Contract Clinical Study Lead

Position Summary:
This role offers a unique opportunity to contribute to the development of innovative cancer therapies. The Contract Clinical Study Lead will independently oversee clinical trial execution, leading cross-functional teams to ensure successful completion of clinical trial activities and deliverables. This position involves managing clinical vendors, coordinating trial activities, and ensuring compliance with regulatory guidelines.

This is a 6-month contract position, with the possibility of transitioning to a permanent role for the right candidate.

Key Responsibilities:

• Lead Study Execution Teams (SET) to initiate and complete clinical trials efficiently, on time, and within budget, ensuring compliance with SOPs, regulatory guidelines, and GCP standards.
• Collaborate with the SET to develop and review Requests for Proposals (RFPs) and support bid defense meetings to select appropriate CROs and clinical vendors.
• Manage CROs and vendors to ensure project milestones align with corporate goals.
• Oversee the development and review of clinical documents, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study plans.
• Manage budgets and contracts, including financial forecasting, invoice reconciliation, and accuracy of vendor work orders and change orders.
• Support the implementation and oversight of clinical systems such as CTMS, TMF, EDC, and IRT.
• Conduct data review, including data listings and summary tables, and generate queries as needed.
• Supervise site management activities, including monitoring reports and quality metrics, in collaboration with CROs.
• Handle site selection, start-up, recruitment, protocol deviation review, and TMF maintenance.
• Monitor study progress and metrics, proactively identifying and addressing risks to achieve timelines and project goals.
• Build strong relationships with internal teams, CROs, vendors, and site personnel to facilitate trial success.
• Provide training on protocols and trial conduct processes to investigators, site staff, and vendors.
• Ensure trials are inspection-ready and participate in audits or regulatory inspections as required.

Requirements:

• Bachelor’s degree in life sciences or a related discipline, with 8–10 years of experience in clinical trial and drug development.
• Advanced knowledge of clinical study and vendor management, particularly in oncology, and a strong understanding of FDA and ICH/GCP regulations.
• Experience with early-phase oncology trials, including precision medicine.
• Self-motivated and focused on continuous improvement and process optimization.
• Strong organizational, analytical, and communication skills in a fast-paced environment.
• Ability to analyze problems, prioritize effectively, and propose solutions.
• Collaborative team player with a track record of building positive relationships.
• Willingness to travel up to 10%.