Manage all aspects of clinical trials, including study vendor management, CRO oversight, timelines, and budgets
Assist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, Clinical Monitoring Plan, Project Plan, Case Report Forms, Clinical Study Reports, and other study level documents
Engage cross-functionally to ensure clear, consistent communication to key stakeholders on study status, metrics and timelines
Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
Serve as point of contact for CRO and clinical site communication
Set up the Trial Master File (TMF) and appropriately maintain the TMF throughout the trial, including periodic reviews
Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation including central clinical files
Proactively identify risks in study timelines in regard to key milestones and deliverables and work closely with the cross-functional teams to mitigate downstream impacts

Requirements

Bachelor’s degree, life science or medical background preferred
7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
Strong interpersonal and organizational skills are needed, with a high degree of attention to detail with ability to flex communication style to all areas of the organization
Working knowledge of Good Clinical Practices (GCP) and other relevant regulatory requirements
Ability to travel up to 10% of the time
Ability to be onsite in the Cambridge office 2 days per week

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementstudy vendor managementCRO oversightclinical study documentationTrial Master File (TMF)audit resolutionrisk identificationGood Clinical Practices (GCP)biopharmaceutical clinical researchclinical trial documentation

Soft Skills

interpersonal skillsorganizational skillsattention to detailcommunication skillscross-functional collaborationproblem-solvingflexibility in communicationstakeholder engagementtimelines managementmetrics communication