GSK - Study Delivery Lead (3-7 yrs)
There is a growing need to deliver strong, convincing evidence to demonstrate the value of our medicines to support positive reimbursement decisions. In order to efficiently and cost effectively deliver this evidence, VEO has established Study Delivery function to lead the operational aspects of our research projects. This capability will provide operational leadership for VEO studies.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
This job within VEO Study Delivery and Quality Operations combines end-to-end design, execution, and reporting of clinical studies and trials as well as supporting the delivery of VEO activities including:
Interventional studies (including randomized clinical trials):
- 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
VEO activities in support of evidence generation (eg literature review, external scientific advice, feasibility assessments)
- This role works across therapy areas (Oncology, Speciality & Primary Care, Vaccine) and includes responsibility and/or accountability for the set-up, coordination, execution and delivery of the VEO and vaccine portfolio in partnership with the Science Lead:
- Planning and leading the delivery of VEO studies to time, quality, budget, company standards and scientific requirements from concept protocol to final study report.
- Leadership of a multifunctional matrix team to ensure study oversight, study delivery and takes operational decisions at study level.
- 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 and Study Management Plan as applicable (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc).
- Responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors.
- The SDL ensures appropriate training of country staff, vendors and sites on protocol and project specific matters - prepare/deliver monitors meeting (when applicable)
- 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, Senior Study Delivery 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
- Co-ordination and delivery of outsourced VEO activities in support of evidence generation (eg literature review, external scientific advice, feasibility assessments)
- Lead escalation and resolution of operational issues
- Manage, in collaboration with Study Delivery Associates (SDA) and Procurement, RFP, proposal, purchase order requesting and contract execution aspects of the activities and liaise with vendors.
- Ensure activities are registered correctly in GSK enterprise systems, in collaboration with central business groups supporting those systems and processes and with other members of VEO Business Operations
- Ensure that VEO activities remain compliant with relevant GSK procedures, remaining up to date with all relevant training and seeking learnings and best practice from other GSK teams and external organisations, to develop best practice and innovation in study operations
- Demonstrated hands-on clinical operations experience preferably across a range of therapeutic areas and/or study types
- Experience in developing and contributing to study protocols, study procedure manuals, informed consent forms, clinical study report, and manuscripts
- Experience of vendor oversight and relationship management etc
- Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP
- Demonstrated ability to create and foster strong strategic partnerships with colleagues that include Clinical
- Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring
- Ability to work independently and proactively
- Proven track record of applying operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
- Excellent communication skills including verbal and written communications, with the ability to present to internal department meetings and external advisory/investigator meetings.
- Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
- Flexibility and willingness to take champion new approaches
- Excellent interpersonal skills
- A collaborative and partnering style.
- Good organizational and time planning skills
Our values and expectations are 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. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
Note: For your candidature to be considered on this job, you need to apply necessarily on the redirected career page of the company as well.