Our client, a small oncology-focused biotech company is currently looking for an experienced Contract Clinical Trial Manager and a Senior Clinical Trial Manager to join their dedicated team.

• 6-month contract, 40 hours per week. (contract could potentially be extended)
• Fully remote (must be located in the Pacific or Mountain time zone - this is required)
• The hourly rate is based on employment options (1099 or W2 contract) and based on experience-whether it's for the CTM or Sr. CTM position.

Responsibilities:

• Lead and support the study execution team to ensure trials are initiated efficiently and completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP guidelines with minimal supervision.
• Collaborate with the study execution team to develop, review, and facilitate Requests for Proposals (RFPs), and contribute to bid defense meetings to select Contract Research Organizations (CROs) and other clinical vendors that align strategically.
• Manage CROs and other clinical vendors to ensure that project and corporate goals are achieved on time and within budget.
• Lead the development and review of key clinical documents, including protocols, informed consent forms (ICFs), case report forms (CRFs), study reference manuals, and study plans.
• Oversee and manage the overall study budget and contracts, forecast financials in partnership with finance, reconcile invoices against accruals, and ensure the accuracy of all CRO/vendor work orders and change order updates.
• Participate in the implementation and oversight of clinical systems, including but not limited to CTMS, TMF, EDC, and IRT.
• Conduct clinical data reviews of data listings and summary tables, including query generation.
• Oversee site management in collaboration with CRO, including the review of monitoring reports and quality metrics.
• Lead additional study activities as needed, such as site selection, start-up, recruitment, protocol deviation management, and TMF review.

Qualifications:

• Bachelors in life sciences or related discipline with 6-10 years of experience in clinical and drug development
• Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology including interpretation and implementation of FDA and ICH/GCP regulations and guidelines
• Early phase oncology trial management experience preferred including precision medicine trials