Job Description
Responsibilities include but are not limited to:
Main responsibilities involve study level project management support which includes the following activities:
- Responsible for operational planning and project management of epidemiology research studies.
- Review of requests for information/proposal, draft scope of work, and responsible for the execution of appropriate service, confidentiality, and consultant agreements and subsequent amendments/change orders, including site contract and subsequent amendments.
- Coordinate and manage due diligence checks, IT and/or privacy assessments, vendor qualification, adverse event reporting and reconciliation, and support to publication submissions.
- Manage study level budget which includes forecasting, tracking invoices/spend, navigating SAP (when applicable), and communicate with stakeholders such as Finance and the Budget Management organization.
- Manage outsourced vendors and communicate with cross functional teams to oversee project status and/or needs.
- Draft and coordinate the review of all suppliers’ operational documents such as the project management, communication plan, operation manual and EC/HGRAC application related documents.
- Participate in quality control assessments and ensure integrity of study data for reports and publications
- Track timelines/deliverables and follow up on action items.
- Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements.
- Collaborate extensively and troubleshoot issues by providing potential resolutions when necessary with internal and external partners to ensure timely management and execution of studies.
- Utilize, manage, and maintain document repositories and internal/external systems (e.g. REDS, Spectrum, RevOps, Veeva Vault, and EnCEPP).
- Coordinate internal/external meetings and draft/review agenda/minutes.
- undefined
Qualifications
- Education: Masters degree in Public Health (or closely related discipline) required.
Required Experience and Skills:
- Three (3) or more years of work experience within clinical/observational research or equivalent experience, experience in lab management is a must, experience in primary data collection study is preferred.
- Strong project management, prioritization skills and problem-solving capability.
- Highly motivated, able to work independently and collaboratively.
- Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders.
- Basic knowledge of epidemiologic or outcomes research is preferred.GCP certificate is preferred.
Required Skills:
Data Management, Epidemiology, Methods and Tools, Operational Performance Management (PM), Operations Management, Outcomes Research, Project Management, Public Health, Public Health Research, Quality Control Management, Quality Management, Regulatory Compliance, Researching, Stakeholder Communications, Stakeholder Relationship Management, Strategic Planning, Technical Advice
Preferred Skills:
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Search Firm Representatives Please Read Carefully
Merck Co., Inc., Rahway, NJ, USA, also known as Merck Sharp Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
no
Job Posting End Date:
09/30/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.
Requisition ID: R409587
