Temp Clinical Trial Management Associate(Hybrid) - Redwoodcity, CA

Title: Temp Clinical Trial Management Associate

Location: Redwood City, CA

Contract: 6 Months - With possible extension

The Opportunity:

• This is a unique opportunity for a Clinical Trial Management Associate (CTMA). You will be responsible for supporting the execution of clinical activities across vendors, CROs, and sites from start-up through. close-out with growing independence. This position will report into the Associate Director.

• Work on problems of a moderate scope, using independent decision-making to select course of action within described guidelines under moderate supervision.

• Serve as Clinical Trial Assistant (CTA) back-up for arranging meeting logistics, agendas, and meeting minutes.

• Maintain tracking systems (e.g., site status, enrollment metrics); assist with study start-up activities (e.g., site feasibility, essential document collection).

• Interact with the Clinical Study Execution Team (CSET), as directed, to complete moderate tasks; interface with vendors and site personnel as needed.

• Ensure document quality and audit readiness in Trial Master File (TMF) with close collaboration with the CTA.

• With moderate supervision from the study lead (or designee), support the review of study documents such as protocols, informed consent forms (ICFs), case reports forms (CRFs), monitoring plans, etc.

• Participate in process improvement initiatives limited to your day-to-day scope.

• Interface with vendors (e.g., central labs, CROs) and site personnel as needed and with limited supervision from the study lead (or designee).

• Mentor and support CTAs.

• Support other Clinical Operations activities as appropriate.

Required Skills, Experience and Education:

• BS, BA, or RN in a relevant scientific discipline.

• 3-5 years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.

• Intermediate knowledge of FDA and EMA Regulatorions, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.

• Good communication and teamwork skills.

• Proficient in MS Office and project tracking tools.

• Strong attention to detail and organization, demonstrate reliability and efficiency in supporting clinical trial operations.

• Take the initiative to independently apply knowledge of Clinical Operations.

• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• High sense of urgency and commitment to excellence in the successful execution of deliverables.

• Ability to multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.

• Travel may be required (~10%).

Preferred Skills:

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.