Serve as a clinical project team member, working closely with the Clinical Program Manager to lead, oversee, and execute assigned clinical studies, including timelines and key deliverables.
Operate at a Program Manager level for day-to-day trial operations while contributing to broader program and operational strategy.
Provide hands-on leadership to initiate and drive study operations, particularly during early phases or transitional periods when program strategy is still evolving.
Develop, maintain, and track study budgets and financials, including invoice and PO management/reconciliation, accrual tracking and reporting, and re-forecasting in collaboration with Clinical Outsourcing, Finance, and Project Management.
Oversee and track study status and timelines; contribute to performance metrics and reporting for assigned clinical studies.
Lead and contribute to the development of clinical study documents, including informed consent forms (ICFs), monitoring plans, recruitment plans, and other study-related materials.
Partner with the Clinical Program Management team on CRO and vendor selection, including RFP processes, contract negotiations, and budget management; serve as a key decision-maker in CRO selection.
Oversee and collaborate directly with CROs, vendors, investigators, monitors, and other external partners.
Lead and participate in cross-functional clinical team meetings; act as the primary point of contact for study-level updates and communication.
Lead and coordinate study start-up activities, including feasibility assessments, investigational product and materials preparation, trial master file (TMF) setup, CRF development, regulatory documentation, and site contracting in collaboration with internal teams.
Support and coordinate data management activities, including database setup, user acceptance testing (UAT), development of edit checks and monitoring guidelines, and data cleaning efforts across sites and systems.
Assist the Clinical Program Manager in coordinating the receipt of ancillary data (e.g., safety labs, analytical labs, IVRS/randomization data) to ensure completeness at database lock.
Contribute to SOP development, process improvements, and training of junior Clinical Trial Managers and Clinical Trial Assistants (CTAs), as well as other departmental initiatives.
Independently manage and deliver complex and/or multiple clinical studies, providing senior-level, hands-on leadership to drive efficient operational execution.
Qualifications
Bachelor’s degree in a scientific or healthcare-related field required; Master’s degree preferred.
10+ years of clinical research experience (or equivalent senior-level experience) within a pharmaceutical, biotechnology, or CRO environment; monitoring experience is a plus.
Strong knowledge of GCP and ICH guidelines for conducting clinical trials.
Demonstrated leadership, interpersonal, organizational, and multitasking skills.
Excellent attention to detail and strong problem-solving abilities.
Ability to work effectively both independently and within a team environment.
