Duration: 5 months to start
Job Description:
Responsible for oversight, coordination, and execution of clinical studies in support of clinical programs. This role combines hands?on trial management with program?level operational leadership to ensure studies progress efficiently and deliver against program objectives.
Responsibilities:
Duties and Responsibilities:
- Clinical project team member: works closely with the Clinical Program Manager and is responsible for leadership, oversight and execution of assigned clinical studies, timelines, and key deliverables.
- Operates at a program manager level for day-to-day trial operations while contributing to higher-level program and operational strategy.
- Provides hands-on leadership to get studies operationally moving, particularly in early stages or during periods of transition, while program strategy may still be evolving.
- Responsible for developing, maintaining and tracking study budgets and financial reporting, including invoice and PO management/reconciliation, accrual tracking
and reporting, and re?forecasting, with Clinical Outsourcing & Finance and Project Management. - Oversees and tracks study status and timelines, and feeds data into performance metrics reporting for assigned clinical studies.
- Initiates and participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents.
- Works closely with Clinical Program Management group on selection of CROs and vendors, RFP process, contract and budget negotiations. Primary decision maker on CRO selection along with CPM and the Clinical Program Management team.
- Oversees and works directly with CROs, vendors, investigators, monitors and other external partners.
- Leads and participates in internal cross?functional clinical team meetings; serves as main point of contact study?level status updates.
- Leads and coordinates study start?up activities including feasibility, investigational product and materials preparation, trial master file setup, CRFs, regulatory documents, and site contracts in conjunction with relevant departments.
- Supports and coordinates tasks related to data management, participates in database creation and user acceptance testing, input for edit checks and
monitoring guidelines, data cleaning activities between study sites, data management and field monitors. - Supports CPM in coordination of receipt of all ancillary data e.g. safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock.
- Participate in SOP development, process mapping, training of junior Clinical Trial Managers and Clinical Trial Assistants (CTA), and other departmental activities.
- Autonomously delivers complex and/or multiple clinical studies with hands?on senior trial leadership to quickly and effectively advance operational execution.
Qualifications:
Education/Skills and Experience Requirements:
- Science background BS or healthcare degree required, Masters preferred.
- Experience:10+ years (or equivalent senior-level experience) in clinical research experience in a pharmaceutical/biotech, CRO setting; monitoring experience a plus.
- Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials.
- Strong leadership, interpersonal, organizational, and multi?tasking skills.
- Excellent attention to detail and problem-solving skills.
- Ability to work effectively work in a team setting.
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