Description
An exciting biopharma company located in Foster City, CA is urgently seeking an in-house Sr CTM to help plan and manage a global Phase III trial. This person will be responsible for vendor, personnel, and study management, leading clinical operations to deliver global and clinical trials. This is a full time, permanent, in-house position, located in Foster City, CA. There is no possibility to work remotely.Responsibilities:
- Responsible for planning and managing clinical research studies
- Establishes and maintains study budget and timelines
- Serves as the primary project lead for communication and coordination of third-party vendors, escalating issues to Senior Management as appropriate
- Coordinates the execution of outsourced Global Phase 2 and 3 Clinical trials
- Manages project contracts, including finalization of initial task order and subsequent amendments, forecasting, assessment of work performed and appropriate site/vendor payments.
- Directs study teams to identify and manage critical path activities such as selection of countries and sites, selection and management of vendors, development of risk management plan, CRF development, EDC system development, study portal setup, study monitoring, safety reporting, IRB/regulatory submissions and approvals, and study status reporting.
- Manages and oversees the performance of the study team to include third-party vendors and Regional CRAs/In-house CRAs
- Participates in the development, review and implementation of departmental SOP's and processes
Qualifications:
- BA/BS degree
- 7+ years of progressively responsible clinical operations experience
- 5+ years experience in global program management for Phase II-III studies
- Experience in managing CRO's, specialty labs and third-party vendors
- Strong knowledge of GCP's, ICH guidelines and study management skills
- Excellent interpersonal skills. Must have the ability to build and maintain positive relationships with management, peers, and direct reports
- Excellent written and verbal skills required. Must display strong analytical and problem solving skills.