Overview The Clinical Data Lead holds a pivotal role within a Series A healthtech/clinical trials company, requiring a candidate with a medical background. They will spearhead the establishment and management of crucial clinical data contracts with hospitals, both domestically and internationally, while also overseeing agreements with CRO and biopharma partners during clinical trial operations. Supported by a team of data engineers, this role involves collaboration across various teams and direct reporting to the CEO. Responsibilities Lead the development and maintenance of clinical data contracts with NHS hospitals and global partners. Oversee data contract negotiations with CRO and biopharma collaborators during clinical trials. Collaborate with data engineers to establish legal, R&D, and technical frameworks for contracts. Work closely with platform and QMS teams, as well as key leadership figures such as the CSO and CTO. Requirements Minimum Requirements: UK applicants only. Full right to work in the UK without restrictions or sponsorship. Medical degree and a minimum of 2 years of NHS experience. GCP trained. Willingness to commute to the Cambridge or London office at least one day per week. Experience in data security policy, data retention policy, and GDPR compliance. Experience in negotiating medical data contracts, including EHR and PACs. Desirable Experience: Completion of specialist hospital or GP training. Knowledge of the biopharma sector. Benefits Flexible working hours. Remote work (with one day in the office each week). 25 days of annual leave, plus bank holidays. Health insurance coverage for you, your partner, and dependents. Contributory pension scheme. Up to £1000/year enrichment fund for career/personal development. Access to a beautiful office in central Cambridge and shared office spaces in London. Opportunities for personal and professional development in a dynamic company. Join a motivated team dedicated to advancing healthcare for universal good. For more information about Shift F5 and the opportunities we have to offer follow us on Shift F5 Ltd is acting as an Employment Agency in relation to this vacancy.
Apr 23, 2024
Full time
Overview The Clinical Data Lead holds a pivotal role within a Series A healthtech/clinical trials company, requiring a candidate with a medical background. They will spearhead the establishment and management of crucial clinical data contracts with hospitals, both domestically and internationally, while also overseeing agreements with CRO and biopharma partners during clinical trial operations. Supported by a team of data engineers, this role involves collaboration across various teams and direct reporting to the CEO. Responsibilities Lead the development and maintenance of clinical data contracts with NHS hospitals and global partners. Oversee data contract negotiations with CRO and biopharma collaborators during clinical trials. Collaborate with data engineers to establish legal, R&D, and technical frameworks for contracts. Work closely with platform and QMS teams, as well as key leadership figures such as the CSO and CTO. Requirements Minimum Requirements: UK applicants only. Full right to work in the UK without restrictions or sponsorship. Medical degree and a minimum of 2 years of NHS experience. GCP trained. Willingness to commute to the Cambridge or London office at least one day per week. Experience in data security policy, data retention policy, and GDPR compliance. Experience in negotiating medical data contracts, including EHR and PACs. Desirable Experience: Completion of specialist hospital or GP training. Knowledge of the biopharma sector. Benefits Flexible working hours. Remote work (with one day in the office each week). 25 days of annual leave, plus bank holidays. Health insurance coverage for you, your partner, and dependents. Contributory pension scheme. Up to £1000/year enrichment fund for career/personal development. Access to a beautiful office in central Cambridge and shared office spaces in London. Opportunities for personal and professional development in a dynamic company. Join a motivated team dedicated to advancing healthcare for universal good. For more information about Shift F5 and the opportunities we have to offer follow us on Shift F5 Ltd is acting as an Employment Agency in relation to this vacancy.
Join Police Digital Service as a Cyber Compliance Specialist - starting salary £70.000 We are looking for a highly experienced and motivated individual to join us as a Cyber Compliance Specialist. You will be a key member of the Police Digital Service (PDS) Cyber Security Team, providing risk and compliance advisory across Policing. About Police Digital Service To protect people from harm in our rapidly changing world, police services must not only keep up with technology and business changes but develop capabilities and ways of working that will enable them to adapt to and deal with the complexity of modern criminality. Key Responsibilities The Cyber Compliance Specialist is responsible for monitoring compliance against national policing policy, standards, and security blueprints. It will offer an exciting opportunity to be involved in collaborative working with police data communities, key stakeholders, partners and suppliers. In particular, the duties of the role involve: Advise and guide users on effective cyber risk management and compliance Identify cyber risks and advise on appropriate controls and mitigations, ensuring these are articulated in terms meaningful to the business Support the resolution of major compliance and risk issues and advise on cyber risk management decisions and remedial actions Advise where risks should not be tolerated and provide a point of escalation, using professional judgement and factoring in risk appetite Review, assess and assure cyber security documentation Advise on cyber risk management matters relating to the supply chain and managed service providers Contribute to the continuous improvement of agreed Cyber processes, policies and standards and advise on ongoing compliance Monitor technological, social and scientific trends that could influence PDS CS risk and compliance planning and management Contribute to the PDS Cyber Services Risk and Compliance monitoring plan Work with the Cyber Policies and Standards team to contribute to information security policies and standards Collaborate on the requirements, design, development and implementation of automated solutions Provide direction, oversight and guidance to security risk and compliance subcontractors Deliver the Police Assured Secure Facilities service and provide metrics to inform compliance and risk reporting Conduct Supplier Assurance for National Systems and services Essential Experience Proven IT/Information security and risk experience in large organisations with complex security and compliance requirements Experience of conducting risk reviews in one or more of the following cloud service provider environments: Microsoft Azure, Amazon Web Services (AWS), Google Cloud Platform (GCP) Experience in defining and/or implementing security controls across multiple layers of the IT architecture stack Strong knowledge and ability to demonstrate the use of the NIST Cyber Security Framework, mapping and translating NIST Cyber Security Controls to other frameworks such as ISO27001 and CIS Top 20 controls, including understanding of the Azure Cloud Adoption Framework Demonstrate a track record of developing strong working relationships with a wide number of stakeholders, particularly in managing expectations across a large number of disparate customer, supplier and stakeholder groups Experience delivering risk and issue remediation in large complex organisations Relevant knowledge and experience in one or more of the following areas: cloud security (security controls, assessments, privacy and regulatory risks, security frameworks), Security Operations, Infrastructure Security, Application Security and DevSecOps Good ability to undertake qualitative and quantitative risk analysis in support of business decision making and information risk management Excellent understanding of both procedural & technical compliance monitoring capabilities Knowledge of supplier assurance frameworks and solutions Demonstrable knowledge of the latest IT thinking and risk modelling methods together with a proven ability to implement and incorporate such solutions into systems and services Ability to develop, with the aid of subject matter experts where appropriate, and implement appropriate risk mitigation actions for identified risks across the organisation. The ability to produce clear, persuasive written and verbal communications which engage and influence colleagues and external stakeholders at a range of levels Good understanding of privacy requirements (including GDPR and DPA 2018) Strong engagement focus and proactive style, that motivates, builds trust and inspires colleagues and other delivery partners to engage with PDS productively Why Join us? Balance is important and we want you to take time off to recharge - we offer 28 days' annual leave plus bank holidays, rising to 30 days after 5 years of service. Holiday Purchase also available Flexible working hours - We trust you to do your job and we appreciate that life doesn't always fit around a 9 to 5 workday. We operate core hours of 10 to 4, Monday to Friday (37hr week) We care about your well-being - we have an EAP that offers not just welfare benefits but also retail discounts Plan for the future - we offer an excellent pension scheme and life assurance cover Put your mind at rest regarding your health - offering remote GP, mental health and physiotherapy appointments via video consultation Family - Enhanced maternity and paternity pay along with a flexible return to work You can find out more here:Benefits - Police Digital Service (pds.police.uk) Diversity, equity and inclusion We are committed to equal opportunity for all and will not discriminate on any grounds. We encourage applications from people from the widest possible span of experience. Working Arrangements This is a remote role.
Apr 18, 2024
Full time
Join Police Digital Service as a Cyber Compliance Specialist - starting salary £70.000 We are looking for a highly experienced and motivated individual to join us as a Cyber Compliance Specialist. You will be a key member of the Police Digital Service (PDS) Cyber Security Team, providing risk and compliance advisory across Policing. About Police Digital Service To protect people from harm in our rapidly changing world, police services must not only keep up with technology and business changes but develop capabilities and ways of working that will enable them to adapt to and deal with the complexity of modern criminality. Key Responsibilities The Cyber Compliance Specialist is responsible for monitoring compliance against national policing policy, standards, and security blueprints. It will offer an exciting opportunity to be involved in collaborative working with police data communities, key stakeholders, partners and suppliers. In particular, the duties of the role involve: Advise and guide users on effective cyber risk management and compliance Identify cyber risks and advise on appropriate controls and mitigations, ensuring these are articulated in terms meaningful to the business Support the resolution of major compliance and risk issues and advise on cyber risk management decisions and remedial actions Advise where risks should not be tolerated and provide a point of escalation, using professional judgement and factoring in risk appetite Review, assess and assure cyber security documentation Advise on cyber risk management matters relating to the supply chain and managed service providers Contribute to the continuous improvement of agreed Cyber processes, policies and standards and advise on ongoing compliance Monitor technological, social and scientific trends that could influence PDS CS risk and compliance planning and management Contribute to the PDS Cyber Services Risk and Compliance monitoring plan Work with the Cyber Policies and Standards team to contribute to information security policies and standards Collaborate on the requirements, design, development and implementation of automated solutions Provide direction, oversight and guidance to security risk and compliance subcontractors Deliver the Police Assured Secure Facilities service and provide metrics to inform compliance and risk reporting Conduct Supplier Assurance for National Systems and services Essential Experience Proven IT/Information security and risk experience in large organisations with complex security and compliance requirements Experience of conducting risk reviews in one or more of the following cloud service provider environments: Microsoft Azure, Amazon Web Services (AWS), Google Cloud Platform (GCP) Experience in defining and/or implementing security controls across multiple layers of the IT architecture stack Strong knowledge and ability to demonstrate the use of the NIST Cyber Security Framework, mapping and translating NIST Cyber Security Controls to other frameworks such as ISO27001 and CIS Top 20 controls, including understanding of the Azure Cloud Adoption Framework Demonstrate a track record of developing strong working relationships with a wide number of stakeholders, particularly in managing expectations across a large number of disparate customer, supplier and stakeholder groups Experience delivering risk and issue remediation in large complex organisations Relevant knowledge and experience in one or more of the following areas: cloud security (security controls, assessments, privacy and regulatory risks, security frameworks), Security Operations, Infrastructure Security, Application Security and DevSecOps Good ability to undertake qualitative and quantitative risk analysis in support of business decision making and information risk management Excellent understanding of both procedural & technical compliance monitoring capabilities Knowledge of supplier assurance frameworks and solutions Demonstrable knowledge of the latest IT thinking and risk modelling methods together with a proven ability to implement and incorporate such solutions into systems and services Ability to develop, with the aid of subject matter experts where appropriate, and implement appropriate risk mitigation actions for identified risks across the organisation. The ability to produce clear, persuasive written and verbal communications which engage and influence colleagues and external stakeholders at a range of levels Good understanding of privacy requirements (including GDPR and DPA 2018) Strong engagement focus and proactive style, that motivates, builds trust and inspires colleagues and other delivery partners to engage with PDS productively Why Join us? Balance is important and we want you to take time off to recharge - we offer 28 days' annual leave plus bank holidays, rising to 30 days after 5 years of service. Holiday Purchase also available Flexible working hours - We trust you to do your job and we appreciate that life doesn't always fit around a 9 to 5 workday. We operate core hours of 10 to 4, Monday to Friday (37hr week) We care about your well-being - we have an EAP that offers not just welfare benefits but also retail discounts Plan for the future - we offer an excellent pension scheme and life assurance cover Put your mind at rest regarding your health - offering remote GP, mental health and physiotherapy appointments via video consultation Family - Enhanced maternity and paternity pay along with a flexible return to work You can find out more here:Benefits - Police Digital Service (pds.police.uk) Diversity, equity and inclusion We are committed to equal opportunity for all and will not discriminate on any grounds. We encourage applications from people from the widest possible span of experience. Working Arrangements This is a remote role.
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Aug 9 2022 Are you energized by an opportunity to strategize on projects and improve platform capabilities across the Clinical Biomarker Group? If so, this Clinical Biomarker Specialist role could be an exciting opportunity to explore. The Clinical Biomarker Specialist will report to the Clinical Biomarker Lead to enhance clinical biomarker strategies for projects and improve platform capabilities across the Clinical Biomarker group. Working as part of the Clinical Biomarkers Team, the Clinical Biomarker Specialist will employ cutting edge technologies and procedures to discover and support technical validation of biomarkers to strengthen clinical biomarker strategies at all stages of clinical development to ensure optimally informed decision making in drug development. The Clinical Biomarker Specialist role provides an opportunity to gain clinical experience and for future development into the Clinical Biomarker Lead role. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Technical validation of biomarkers for use in clinical trials and in observational studies. Working with internal technology groups, Contract Research Organisations and collaborators to deliver clinical biomarker assays. Providing input on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, Study Reference Manuals and Central Lab Worksheets. Ensuring alignment of biomarker outputs with data management, statistics, and modelling/simulation requirements. Liaise with other parts of the organization to resolve study biomarker issues. Evaluating the value and suitability of new technologies for potential use in clinical trials. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD-educated scientist (or equivalent) in life sciences (background/degree in immunology an advantage) with at least 2 years of experience in pharmaceutical industry supporting pipeline progression. Experience with the discovery, validation and implementation of biomarkers. Excellent communication skills and positive can-do attitude. Good interpersonal and matrix working skills. Preferred Qualifications: If you have the following characteristics, it would be a plus: In depth knowledge of GCP principles. Experience of clinical implementation of biomarker technologies. at least 2 years of experience in pharmaceutical industry supporting pipeline progression. Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Sep 24, 2022
Full time
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Aug 9 2022 Are you energized by an opportunity to strategize on projects and improve platform capabilities across the Clinical Biomarker Group? If so, this Clinical Biomarker Specialist role could be an exciting opportunity to explore. The Clinical Biomarker Specialist will report to the Clinical Biomarker Lead to enhance clinical biomarker strategies for projects and improve platform capabilities across the Clinical Biomarker group. Working as part of the Clinical Biomarkers Team, the Clinical Biomarker Specialist will employ cutting edge technologies and procedures to discover and support technical validation of biomarkers to strengthen clinical biomarker strategies at all stages of clinical development to ensure optimally informed decision making in drug development. The Clinical Biomarker Specialist role provides an opportunity to gain clinical experience and for future development into the Clinical Biomarker Lead role. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Technical validation of biomarkers for use in clinical trials and in observational studies. Working with internal technology groups, Contract Research Organisations and collaborators to deliver clinical biomarker assays. Providing input on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, Study Reference Manuals and Central Lab Worksheets. Ensuring alignment of biomarker outputs with data management, statistics, and modelling/simulation requirements. Liaise with other parts of the organization to resolve study biomarker issues. Evaluating the value and suitability of new technologies for potential use in clinical trials. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD-educated scientist (or equivalent) in life sciences (background/degree in immunology an advantage) with at least 2 years of experience in pharmaceutical industry supporting pipeline progression. Experience with the discovery, validation and implementation of biomarkers. Excellent communication skills and positive can-do attitude. Good interpersonal and matrix working skills. Preferred Qualifications: If you have the following characteristics, it would be a plus: In depth knowledge of GCP principles. Experience of clinical implementation of biomarker technologies. at least 2 years of experience in pharmaceutical industry supporting pipeline progression. Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
* SUMMARY: This is a seasoned leadership role accountable for site activation project management and delivery in the Site Activation and Regulatory (SAR) department. Project activities include site identification, investigator and site contracts, central and local EC submissions, Competent Authority submissions and any other country and/or study specific activities necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). It may also include proposal and budget management or feasibility/site identification activities. Reports to the Site Activation and Regulatory Therapeutic Lead or may report to a Site Activation Portfolio Manager if assigned to a portfolio or program of studies * *RESPONSIBILITIES:* * Serve as the primary point of communication and accountability for start-up and maintenance (if applicable) activities on assigned projects * Lead and manage assigned SAR project teams to achieve successful delivery of milestone achievements and any key performance indicators * May perform line management activities with; responsibility for direct report performance, development and administrative compliance * Oversee project activities of Regulatory Affairs Specialists and Site Activation Specialists to ensure critical path activities completed on time * Ensure accurate compilation, management, tracking and analysis of site activation activities in timely manner * Work closely with assigned team members to expedite the Site Qualification and Selection process * Effectively communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM and project team * Lead risk assessment and mitigation plans relating to departmental deliverables with input from other roles * Work with and lead project team members to develop site activation related project plans, such as the study-specific Site Activation Plan which includes all activities required to activate sites for a specific study ensuring each task has a clear owner and due date. Liaise with other functional contributors and vendors as needed. * Help develop, review, and maintain SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation department * Lead/provide input to departmental process improvement initiatives * Recommend, establish and interpret site activation metrics; drive corrective action to achieve deliverables, milestones and KPIs * May participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals budgets, and other country and/or study specific activities related to Site Activation * Report and/or escalate issues to Site Activation & Regulatory Therapeutic Lead as necessary to ensure resolution and minimize risks to on-time deliverables * Comply with SOPs, ICH GCP and national regulations as applicable * May lead or support feasibility or site identification activities * Liaise with other functional contributors and vendors as needed * OTHER SKILLS AND ABILITIES: * * Proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing * Demonstrated ability to exercise sound judgment and consistently make decisions independently to proactively prevent and solve problems * Demonstrated ability to consistently positively impact initiatives relating to interacting with sites and/or customers * Demonstrated ability to motivate, lead and engage a team to consistently and successfully achieve meaningful goals * Demonstrated ability to perform and thrive in ambiguous situations * Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment * Strong oral and written communication skills to clearly and concisely present information * Demonstrated ability to collaborate across the business * Team-oriented work style; seeks and gives guidance * Thorough understanding of regulatory processes, guidelines, and the application of local regulatory requirements * Thorough understanding of initiation, planning, and execution of clinical projects and overall project planning * Thorough awareness of ICH GCP Guidelines and the FDA/ EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications) * Demonstrated ability to handle multiple tasks in a fast-paced and constantly changing environment * Demonstrated ability to work in an organized, methodical and self-motivated manner * Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude * REQUIREMENTS: * * A minimum four-year college curriculum or equivalent with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR... * Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and four years' experience within clinical research (e.g. CRA, Reg Affairs.) * Plus a minimum of 7 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience * Proficient in cross-cultural communication * Proficient in both spoken and written English #LI-MP1 #LI-Remote
Feb 25, 2022
Full time
* SUMMARY: This is a seasoned leadership role accountable for site activation project management and delivery in the Site Activation and Regulatory (SAR) department. Project activities include site identification, investigator and site contracts, central and local EC submissions, Competent Authority submissions and any other country and/or study specific activities necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). It may also include proposal and budget management or feasibility/site identification activities. Reports to the Site Activation and Regulatory Therapeutic Lead or may report to a Site Activation Portfolio Manager if assigned to a portfolio or program of studies * *RESPONSIBILITIES:* * Serve as the primary point of communication and accountability for start-up and maintenance (if applicable) activities on assigned projects * Lead and manage assigned SAR project teams to achieve successful delivery of milestone achievements and any key performance indicators * May perform line management activities with; responsibility for direct report performance, development and administrative compliance * Oversee project activities of Regulatory Affairs Specialists and Site Activation Specialists to ensure critical path activities completed on time * Ensure accurate compilation, management, tracking and analysis of site activation activities in timely manner * Work closely with assigned team members to expedite the Site Qualification and Selection process * Effectively communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM and project team * Lead risk assessment and mitigation plans relating to departmental deliverables with input from other roles * Work with and lead project team members to develop site activation related project plans, such as the study-specific Site Activation Plan which includes all activities required to activate sites for a specific study ensuring each task has a clear owner and due date. Liaise with other functional contributors and vendors as needed. * Help develop, review, and maintain SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation department * Lead/provide input to departmental process improvement initiatives * Recommend, establish and interpret site activation metrics; drive corrective action to achieve deliverables, milestones and KPIs * May participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals budgets, and other country and/or study specific activities related to Site Activation * Report and/or escalate issues to Site Activation & Regulatory Therapeutic Lead as necessary to ensure resolution and minimize risks to on-time deliverables * Comply with SOPs, ICH GCP and national regulations as applicable * May lead or support feasibility or site identification activities * Liaise with other functional contributors and vendors as needed * OTHER SKILLS AND ABILITIES: * * Proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing * Demonstrated ability to exercise sound judgment and consistently make decisions independently to proactively prevent and solve problems * Demonstrated ability to consistently positively impact initiatives relating to interacting with sites and/or customers * Demonstrated ability to motivate, lead and engage a team to consistently and successfully achieve meaningful goals * Demonstrated ability to perform and thrive in ambiguous situations * Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment * Strong oral and written communication skills to clearly and concisely present information * Demonstrated ability to collaborate across the business * Team-oriented work style; seeks and gives guidance * Thorough understanding of regulatory processes, guidelines, and the application of local regulatory requirements * Thorough understanding of initiation, planning, and execution of clinical projects and overall project planning * Thorough awareness of ICH GCP Guidelines and the FDA/ EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications) * Demonstrated ability to handle multiple tasks in a fast-paced and constantly changing environment * Demonstrated ability to work in an organized, methodical and self-motivated manner * Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude * REQUIREMENTS: * * A minimum four-year college curriculum or equivalent with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR... * Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and four years' experience within clinical research (e.g. CRA, Reg Affairs.) * Plus a minimum of 7 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience * Proficient in cross-cultural communication * Proficient in both spoken and written English #LI-MP1 #LI-Remote
EMEA GVP Consultant / Auditor Salary up £70,000 per annum plus benefits Location - home based / remote Are client, an international specialist consultancy offers a full range of independent GCP, GVP, GLP and GMP Quality Assurance and Quality Management services on a global basis. Due to company expansion they are now looking for an experienced GVP consultant / auditor to join their pharmacovigilance practice. What will the role typically involve? * Delivering projects in compliance with agreed project proposals * Project management of PV Audit programs * Performing the role of Project Lead and Client liaison * Preparation, conduct and reporting of PV system audits at clinets, service providers, marketing partners, distributors What will you bring * Strong experience conducting and leading internal and external PV audits * Expert knowledge of PV regulations and guidance with a strong focus on EU * Ability to work effectively to tight deadlines * Ability to work proactively, identify issues and dealing with solutions effectively * Willingness to travel (around 40%) For further information please contact Louise on (0)
Mar 24, 2021
Full time
EMEA GVP Consultant / Auditor Salary up £70,000 per annum plus benefits Location - home based / remote Are client, an international specialist consultancy offers a full range of independent GCP, GVP, GLP and GMP Quality Assurance and Quality Management services on a global basis. Due to company expansion they are now looking for an experienced GVP consultant / auditor to join their pharmacovigilance practice. What will the role typically involve? * Delivering projects in compliance with agreed project proposals * Project management of PV Audit programs * Performing the role of Project Lead and Client liaison * Preparation, conduct and reporting of PV system audits at clinets, service providers, marketing partners, distributors What will you bring * Strong experience conducting and leading internal and external PV audits * Expert knowledge of PV regulations and guidance with a strong focus on EU * Ability to work effectively to tight deadlines * Ability to work proactively, identify issues and dealing with solutions effectively * Willingness to travel (around 40%) For further information please contact Louise on (0)