Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines.
Serves as study lead and primary contact for sponsors.
Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory.
Generates and presents frequent study status updates and reports to sponsor.
Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.
Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones.
Identifies issues and develops problem-solving strategies to ensure study timelines are met.
Prepares for and participates in third-party audits and FDA inspections.

BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience
10 years of experience in the pharmaceutical / biotechnology / CRO industry with at least 5 years of clinical project management experience
Proven ability to be careful, thorough, and detail-oriented
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
Strong command of English, both written and verbal
Proficient with MS Office Suite, particularly Word and Excel
Permanent authorization to work in the U.S.

Senior Clinical Project Manager

Key skills