PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges.
PATH’s Center for Vaccine Innovation and Access (CVIA) brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA’s current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against fifteen different diseases. Our focus is on vaccines to address the leading diseases that claim children’s lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others. PATH has led numerous global partnerships, including the award-winning Meningitis Vaccine Project and the Malaria Vaccine Initiative, which helped develop the first malaria vaccine candidate recommended for pilot implementation.
CVIA’s 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.
PATH is currently recruiting for a Data Manager who 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 Management in 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.
- Contribute to the development and maintenance of DM-related Quality documents.
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.
- Bachelor's degree in a related field and at least 3-5 years of experience in clinical research required. In addition, education or experience in statistics and ability to contribute to statistical activities on an as-needed basis preferred.
- Proven experience in clinical study DM operations, including the following:
- Selecting CROs to provide DM services to support clinical studies.
- Selecting quality Electronic Data Capture systems to support clinical studies.
- Continuous monitoring of data entry directed at identification of issues and trends.
- Identification of problems and development of solutions for complex data issues.
- Data review and cleaning.
- Data release and database closure.
- CRO management.
- Extensive knowledge of the clinical research development process and relevant regulatory guidelines. Specific experience in vaccine clinical trials preferred.
- Experience with DM tools and other data management and analysis software. Experience with Oracle Clinical, EDC systems, and CDISC standards. Experience with statistical software, such as SAS and/or R preferred.
- Ability to work on multiple projects simultaneously, with flexibility to work both collaboratively and independently in a multidisciplinary project environment.
- Strong oral and written communication skills in English.
- Must have legal authorization to work in the country of PATH office location.
COVID-19 Vaccine Requirement:
PATH has instituted a COVID-19 vaccine mandate for all employees, interns, consultants, and temporary staff based in the United States. Individuals selected for job opportunities in the United States must be fully vaccinated, and show proof of vaccination status, upon hire. Individuals are considered fully vaccinated 2 weeks after their second dose in a 2-dose series, such as Pfizer or Moderna, or 2 weeks after a single-dose vaccine, such as Johnson & Johnson. Individuals with medical issues or sincerely held religious beliefs that prevent them from getting the vaccine may request an exemption from the vaccine requirement.
PATH is dedicated to building an inclusive workforce where diversity is valued.
PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.