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.
Supervises and trains Associate CPMs and provides ongoing support and high-level guidance to CPMs.
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.
Ensures accuracy of reports and material work product.
Provides monthly billing information to finance team.
Presents at project meetings such as investigator meetings and new client meetings.
Updates management accurately and regularly through frequent communication.
Identifies issues and develops problem-solving strategies to ensure study timelines are met.
Manages subject accrual, retention, and compliance.
Assists in TMF management and manages TMF reviews as needed.
Prepares for and participates in third-party audits and FDA inspections.
Complies withand ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs.
Participates in internal, client/sponsor, scientific, and other meetings as required.
Performs additional duties as assigned.
