Job Description
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.Desired Skills and Experience
Clinical Trial Management, Clinical Operations, CRO management, vendor management, TMF management, clinical study execution, CSET coordination, site management, study start-up, site feasibility, essential document collection, enrollment tracking, FDA regulations, EMA regulations, ICH Guidelines, GCP compliance, protocol review, informed consent forms, case report forms, monitoring plans, clinical documentation, audit readiness, eTMF, EDC, IRT, CTMS, oncology trials, early stage trials, late stage trials, Clinical Trial Assistant supervision, process improvement, site personnel coordination, central lab coordination, meeting coordination, MS Office, project tracking tools, pharmaceutical industry, biotech industry, clinical research, BS / BA / RN scientific discipline, 3-5 years clinical experience
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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