Implementation Project Manager, eClinical & Pharmacovigilance
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Job Description
Structured overview of role & requirementsAbout This Role
Own end-to-end delivery of eClinical and Pharmacovigilance software implementations from project kickoff through go-live and hypercare for 3-5 concurrent projects.
Manage scope, timeline, budget, validation compliance, and stakeholder communication across clinical operations, safety, IT, and quality domains.
Lead requirements gathering, solution design, data migration, integrations, validation, customer training, and identify expansion opportunities to drive customer success and revenue growth.
Minimum Requirements
6+ years project management experience with at least 4 years implementing eClinical or safety/PV systems (e.g., CTMS, eTMF, EDC, Argus, Veeva Vault).
Experience managing multiple concurrent full-lifecycle GxP-regulated implementations including CSV/CSA validation deliverables.
Working knowledge of clinical trial operations or pharmacovigilance workflows and regulatory compliance (GxP, 21 CFR Part 11, EU Annex 11, ICH E6(R3), GVP).
Bachelor's degree in life sciences, pharmacy, engineering, computer science, or a related field.
Ideal Candidate Profile
Experienced managing distributed teams across US and India with strong skills in workshop facilitation and executive communication.
Proficient in hybrid Agile/Waterfall delivery, project budgeting, and change management within regulated environments.
Candidate with prior experience at CRO/pharma sponsors or eClinical vendors and familiarity with Salesforce, safety database migrations, or AI-enabled clinical/safety workflows is preferred.
