Clinical Trial Manager Jobs

Clinical Trial Manager/Sr

Onsite 100% in Redwood City, CA

12mth contract (potential of extension/conversion based on performance and ongoing need)

This position will include managing operational activities for assigned studies, may assume responsibility for additional vendors, studies and/or clinical programs, and provide operational leadership to ensure the study milestones are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. Successful candidate will help establish new processes and work instructions to ensure consistent, effective, and efficient execution of clinical operation activities. Partnering with key stakeholders (internal and external), the goal is to ensure continuous harmonized operations of clinical operations activities, and maintain high standards for performing in a cross-functional environment.

**This opportunity may have future direct management responsibilities.

Responsibilities:

• Assist with the analysis and development of action plans to address issues with investigational sites and/or vendors.
• Support vendor selection, onboarding, management, and oversight of multiple vendors including but not limited to CRO (including RFPs and bid defense for CRO and finalization of SOW), imaging, central and specialty labs, eCOA, and compliance.
• Responsible for the review and oversight of tasks in study management plans for operations and all operational activities associated with clinical trials.
• Ensure inspection-readiness for all assigned studies, including ensuring all components of the trial master file (TMF/eTMF) are up to date and accurate.
• Assist with the planning, coordination, and presentation at Investigator Meetings and CRA Training meetings, SIVs, and ad hoc trainings, as requested.
• Manage vendor operational meetings to ensure project goals and timelines are met.
• Participate in the development and review of study related materials, including but not limited to informed consent forms, case report forms, study manuals and plans, and other supporting clinical trial materials.
• Responsible for study start-up, including working with cross functional teams on startup, and with the CRO on site selection/activation
• Support Study Lead and take on responsibility and management of clinical trial to ensure that corporate goals are met, studies are completed on time, within budget, and in compliance with SOPs, FDA/EMA regulations and ICH/GCP guidelines.
• Review/approve invoices, and ensure timely payment processing for vendors, including investigative sites (as applicable).
• Create study specific tools and manuals to ensure timeliness, standardization, and control of data quality.
• Act as the study lead delegate on cross-functional study teams, Vendor, and CRO operational meetings and ensure compliance with global operational standards and procedures.
• Assist with or be responsible for the management of key study parameters (e.g., start-up activities, site feasibility, enrollment, site management, data collection, data review, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.

Education/Experience:

• BA required, preferable in a scientific/medical field. Advanced degree preferred.
• Early phase and start up experience required.
• Demonstrated experience in selecting, managing, overseeing, and successfully developing effective relationships with multiple vendors and CROs.
• 7-10 years of experience in Clinical Operations or related function, working with CROs and other vendors, with increasing responsibility and scope; Oncology experience preferred.
• Prior experience working in a start-up environment is a highly desired.