Project Manager - FSP/NIS Study Delivery Lead

at  Thermo Fisher Scientific

JOB DESCRIPTION

Client Job Description:
NIS Study Delivery Lead

This position combines end-to-end design, execution, and reporting of clinical studies and trials including:

• Non-interventional studies using primary data collection, including prospective studies enrolling patients and / or HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g. with EMRs / chart abstraction), patient reported outcomes development and validation.
• Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilisation studies, prevalence / incidence studies of exposure, risk factors and outcomes.
• Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients.
• Economic modelling studies and supplemental analyses of clinical trials / meta-analyses.
• Interventional and low-interventional studies.

Key attributes include scientific credibility, demonstrated ability to provide input on and influence studies / projects through scientific and operational expertise, and demonstrated excellence in stakeholder management. This job requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change and curiosity.
Essential behaviours valued include: The ability to lead and drive change, continuous improvement and learning, effectiveness at building networks of partners and stakeholders. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential.

This includes responsibility and / or accountability for the set-up, coordination, execution and delivery of studies in partnership with the Science Lead:

• Planning and leading the delivery of NIS to time, quality, budget, company standards and scientific requirements from concept protocol to final study report.
• Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.
• Accountable for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms / tools etc).
• With the majority of NIS fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors.
• Ensure compliance with ICH / GCP & ENCePP guidelines and/or applicable guidelines for studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
• Make decisions which balance risk / benefit with clear understanding of the impact on the study and project; acts to mitigate risk where appropriate.
• Work with matrix partners, Study Delivery Director and/or manager to develop and manage study level budget within project budget allocation.
• Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills.

The position may include:

• Leadership of a study team with single point accountability for delivery of the study
• Have primary responsibility and be a focal point of contact for interactions with key stakeholder groups including lead scientists (epidemiologists, health economists, health outcomes, etc.) data management, biostatistics, legal, compliance and project management.
• Responsibility for reviewing and/or enhancing the technical and scientific robustness of clinical plans and studies developed by the key customers for their designated area, while inputting and influencing.
• Lead and drive significant cross-therapeutic / functional business change initiatives according to company and/or group strategy and business needs. Be accountable for implementing new business processes and strategies; may also proactively identify issues and propose strategies to manage implications and risks on study timelines, budgets and goals.
• Drive innovative approaches to study delivery through external facing advances in technology and sciences
• Supporting technical and leadership development of Study Delivery staff via mentoring and coaching.
• Work with matrix partners to develop and manage study level budget within project budget allocation. Look for ways to use resource most effectively to manage workload within budgets and headcount allocation.
• Have an established track record of generating alternative solutions and perspectives at study and line level. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.

Basic Requirements

• Broad understanding of the pharmaceutical industry and the clinical development process.
• In depth knowledge of study management and knowledge of essential regulatory guidelines worldwide and GSK company policies.
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary.
• Ability to work independently and proactively and to take on leadership roles on cross-functional study teams.
• Excellent leadership skills.
• Excellent influencing and negotiation skills.

Preferred Requirements

• Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.
• Demonstrated experience leading in matrix environment to deliver projects, develop clinical plans, and manage change.

• Planning and leading the delivery of NIS to time, quality, budget, company standards and scientific requirements from concept protocol to final study report.
• Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.
• Accountable for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms / tools etc).
• With the majority of NIS fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors.
• Ensure compliance with ICH / GCP & ENCePP guidelines and/or applicable guidelines for studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
• Make decisions which balance risk / benefit with clear understanding of the impact on the study and project; acts to mitigate risk where appropriate.
• Work with matrix partners, Study Delivery Director and/or manager to develop and manage study level budget within project budget allocation.
• Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills