Strategy & Governance Director, Epidemiology & Real World Evidence
- Master of Science degree in a Life Sciences subject
- 7-10 years of experience in a pharmaceutical industry environment
- 5-7 years of experience in project management
- 3-5 years of experience in quality/compliance role
- Experience working with GSK systems and processes
- Experience working with vendors and academic groups & monitoring them for compliance during study conduct.
Epidemiology and RWE team is supporting a rapidly expanding HIV portfolio, trying to meet the increasing demand for Real World Data. The overall purpose of this role is to ensure that streamlined research, governance, data disclosure, compliance and operations management is in place within the Epidemiology and RWE team within ViiV's Global Medical Sciences Organization in order to meet the department's organizational, compliance, and project management objectives and obligations. In addition the role will work with the Global Head on strategy for the Epidemiology & RWE team, projecting resource needs and future direction for the team.
This role will provide strategic, tactical, project management, and governance support to the Epidemiology and RWE team. The role will provide an important interface with external suppliers of Epidemiology and RWE related services including CROs, Academic Institutions, HCPs, External Experts and other service providers. It will work with GSK Epidemiology and RWE group and business support functions to ensure Epidemiology and RWE research and operations management remains effective. It will ensure core Epidemiology and RWE procedures, practices and training requirements for existing and new staff are clearly defined, documented and communicated. The role will also provide scientific support to the head of Epidemiology and RWE in conducting non-interventional studies.
- Contribute to the drafting and critical review of Epidemiology and RWE protocols and facilitate the PRC review process.
- Provide critical review of Epidemiology and RWE study deliverables including draft and final reports.
- Contribute to the drafting and critical review of congress abstracts, journal publications, and Data Dissemination Plans as needed.
- Oversee the registration of Epidemiology and RWE studies in OPT, OneCDP, and eTrack.
- Serve as the SAP role for Epidemiology and RWE studies in eTrack by providing monthly positive confirmation, ensuring eTrack study data is up to date, and resolving eCoMP errors.
- Ensure Epidemiology and RWE studies are disclosed to the ViiV Clinical Study Register and EU PAS Register per POL408 requirements.
- Contribute to and draft sections of regulatory documents including PBRERs, NDA Annual Reports, DSURs, Clinical Overviews, and Risk Management Plans and facilitate posting of NDA AR checklists to internal database.
- Financial Management: Ensure the accuracy of finance data within Hyperion and finance payment systems by liaising with finance partners at both GSK and ViiV to support Epidemiology and RWE studies.
- Provide forecasting and reporting of quarterly and annual budgets for Epidemiology and RWE studies.
- Develop and continuously update Epidemiology and RWE study lists and evidence generation plans to support VET portfolio planning and transparency across the ViiV CSMO organization.
- Update quarterly project management reports, FTE forecast estimates, and IEPs for required ViiV assets.
- Vendor management: Facilitate the non-approved supplier due diligence process for Epidemiology and RWE studies that do not use Approved suppliers.
- Serve as the key contact for contract management and execution, working with CGOM, TPR, Procurement and external suppliers.
- Draft and implement Oversight Plans for external vendors with executed contracts.
- Work with Procurement to put MSAs in place with external suppliers as needed.
- Ensure compliance with outsourcing and operationalizing HCP reporting requirements
- Serve as the key contact for HCP tracking and payment and ensure payments are reported in accordance with Sunshine Act requirements.
- Develop policies and procedures related to the conduct of Epidemiology and RWE studies as needed and ensure that in scope parties are adequately trained.
- Provide guidance on SOPs/policies/governance processes (ABAC, Scientific Engagement, US Sunshine Act, etc) and provide "need to know" communications and/or training as necessary.
- Work with Compliance to understand and implement role specific policy-related requirements.
- Facilitate the development and delivery of responses to audits and inspections including the creation of CAPAs.
- Create and maintain the ViiV Epidemiology and RWE teamsite for storage of study and compliance documents.
You may apply for this position online by selecting the Apply now button.
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