PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, technology, advocacy, and dozens of other specialties, PATH develops and scales innovative solutions—including vaccines, drugs, devices, diagnostics, and approaches to strengthening health systems worldwide.
The Center for Vaccine Innovation and Access (CVIA) Clinical Functional Team provides leadership and support to the clinical activities conducted by various programs developing vaccines and drugs for implementation in low-resource settings, including the design of clinical development plans, protocols and related documents, implementation of clinical trials, monitoring and oversight of all trial activities, filing and maintaining control of all essential documents and providing support for regulatory submissions leading to local registration and WHO prequalification of new vaccines.
The Data Manager will be responsible for conducting a number of activities in support of clinical trials of multiple vaccine candidates conducted within CVIA and will report to the Director of Statistics and Data Managementin the CVIA Clinical Functional Area. This newly created position will continue the advancement of in-house Data Management (DM) activities.
- Play an active role in multi-disciplinary project and study teams by supporting DM activities in all phases of projects related to clinical development programs to ensure the consistency, accuracy and integrity of clinical trial data.
- Work with the study team to develop and review RFPs and assist with CRO selection.
- Work with CROs and other partners (e.g. subcontracted vendors, IWRS, pharmacovigilance and laboratory vendors) to develop, implement, and successfully complete clinical study data capture and its summarization.
- Provide oversight of CRO activities during the implementation of clinical studies.
- Oversee the development and implementation of project timelines and monitor the progress of data management activities.
- Review study documents developed by the CRO including but not limited to: CRF, data management plan, data validation plan, CRF Completion guidelines, edit checks, and data transfer specifications.
- Perform User Acceptance Testing on clinical databases in development.
- Review and track data cleanliness from individual trials.
- Oversee the development and implementation of study metrics and provide input into the preparation of study reports.
- Work with the study team to define and monitor study risks and appropriate mitigation.
Additional responsibilities, dependent on candidate qualifications:
- Support protocol statisticians in review of documents including statistical analysis plans and mock tables listings and figures and/or participate in quality control efforts of statistical analysis and conduct analyses independently.