Clinical Trial Management Associate (CTMA)

Clinical Trial Management Associate (CTMA)

W2 Contract-to-Hire

Salary Range: $124,800 - $145,600 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

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 to the Associate Director, Clinical Operations or Clinical Program Manager.

Duties and Responsibilities:

• Work on problems of a moderate scope, using independent decision-making to select a 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 the 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 report 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.

Requirements and Qualifications:

• 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 Regulations, 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 demonstrates 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 the 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 Qualifications:

• Has familiarity working with vendor systems/portals (eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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