Sr. Spclst, Project Management
Merck
4 hours ago
Remote friendly (Philadelphia, PA)
United States
Operations
Responsibilities:
- Coordinate observational/non-interventional research activities, including primary-data collection, chart review/surveys, database studies, and health economic model development/adaptations to support HTA.
- Provide operational support to scientists in conducting research in compliance with GPP, company policies, and SOPs.
- Manage execution and closeout of data collection, chart review, and database studies; manage multiple complex study types.
- Oversee suppliers and communicate with internal cross-functional teams on status and mitigations; track timelines/deliverables and follow up on action items.
- Assist in review/finalization of supplier documents (monitoring, PM, safety, data management, validation plans).
- Support protocol and interim/final report preparation; shepherd documents through internal review and submit to the internal repository.
- Manage internal/external meetings (agendas/minutes) and ensure informed consent, compliance, contracts/budget approvals, study registration (when applicable), AE reconciliation, publication submission, and closeout.
- Coordinate confidentiality/consultant agreements; support QC/integrity of study data; manage publication development and troubleshoot issues.
- Participate in process improvement and mentor other research managers as needed.
Qualifications:
- Bachelor’s degree in life sciences/public health (or related).
- 3–5+ years in clinical/observational research.
Preferred:
- Master’s degree in life sciences/public health (or related).
Required Skills (selected): Project management, prioritization, epidemiology/outcomes research knowledge, health economics/HTA, data analysis, RWE, regulatory compliance, risk/safety management, meeting management.
Benefits (explicitly stated): medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline stated on posting.
- Coordinate observational/non-interventional research activities, including primary-data collection, chart review/surveys, database studies, and health economic model development/adaptations to support HTA.
- Provide operational support to scientists in conducting research in compliance with GPP, company policies, and SOPs.
- Manage execution and closeout of data collection, chart review, and database studies; manage multiple complex study types.
- Oversee suppliers and communicate with internal cross-functional teams on status and mitigations; track timelines/deliverables and follow up on action items.
- Assist in review/finalization of supplier documents (monitoring, PM, safety, data management, validation plans).
- Support protocol and interim/final report preparation; shepherd documents through internal review and submit to the internal repository.
- Manage internal/external meetings (agendas/minutes) and ensure informed consent, compliance, contracts/budget approvals, study registration (when applicable), AE reconciliation, publication submission, and closeout.
- Coordinate confidentiality/consultant agreements; support QC/integrity of study data; manage publication development and troubleshoot issues.
- Participate in process improvement and mentor other research managers as needed.
Qualifications:
- Bachelor’s degree in life sciences/public health (or related).
- 3–5+ years in clinical/observational research.
Preferred:
- Master’s degree in life sciences/public health (or related).
Required Skills (selected): Project management, prioritization, epidemiology/outcomes research knowledge, health economics/HTA, data analysis, RWE, regulatory compliance, risk/safety management, meeting management.
Benefits (explicitly stated): medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline stated on posting.