Clinical Study Manager
- Stevenage, Hertfordshire (GBR)
- £450 - £480 Per Day
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00096629
- clinical study
- data management
- pharmaceutical
- protocol
- sops
- trials
- datasets
- pharmacovigilance
- project management
- medical data
This Study Delivery Lead role within VEO Study Delivery and Quality Operations involves the end-to-end design, execution, and reporting of clinical studies and trials.
Key attributes include scientific credibility, demonstrated ability to input to and influence studies/projects through scientific and operational expertise, and excellence in stakeholder management. This job requires the ability to lead and drive change, strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change and curiosity.
Essential behaviours include continuous improvement and learning, effectiveness at building networks of partners and stakeholders and the ability to lead and inspire others. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential.
Key Responsibilities include, but are not limited to:
This role includes responsibility and/or accountability for the set-up, coordination, execution, and delivery of the VEO portfolio in partnership with the Science Lead:
- Planning and leading the delivery of VEO studies to timelines, 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 VEO studies 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 VEO 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 impact on the study and project; acts to mitigate risk where appropriate
- Work with matrix partners, Study Delivery Therapy Area Lead 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 will include:
- Leadership of a study team with single point accountability for delivery of the study
- Have primary responsibility and be the point of contact for interactions with Value Evidence Leaders/Scientists, Epidemiologists, Medicines leaders (e.g. MDLs, PPLs, GMALS), and other key stakeholder groups including data management, analytics, legal, compliance and project management
Basic Requirements
- Broad understanding of the pharmaceutical industry and the clinical development process
- Ability to establish and build internal and external relationships at all levels in a highly dynamic matrix 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 negotiation skills
Preferred Requirements
- In depth knowledge of study management and knowledge of essential regulatory guidelines worldwide
- 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 a matrix environment to deliver projects, develop clinical plans, and manage change
- Experience in managing relationships with vendors to ensure successful delivery of projects
About VEO
In Value, Evidence and Outcomes (VEO), we lead a wide variety of studies to support the development and reimbursement of GSK’s innovative medicine portfolio. The VEO family is made up of Value Evidence scientists, epidemiologists, patient centred outcomes scientists, patient focussed development leads, data analysts and modellers, as well as critical support functions of study delivery, project management, quality, and business operations who work together to deliver an expanding portfolio.
The types of studies run by VEO include:
- Interventional studies
- 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
