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Clinical Trial Management Associate
700 Saginaw Drive Redwood City, CA 94063 US
Job Description
Clinical Trial Management Associate
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, Clinical Operations.
Responsibilities:
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Work on problems of a moderate scope, using independent decision-making to select course of action within described guidelines under moderate supervision.
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Serve as Clinical Trial Assistant (CTA) back-up for arranging meeting logistics, agendas, and meeting minutes.
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Maintain tracking systems (e.g., site status, enrollment metrics); assist with study start-up activities (e.g., site feasibility, essential document collection).
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Interact with the Clinical Study Execution Team (CSET), as directed, to complete moderate tasks; interface with vendors and site personnel as needed.
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Ensure document quality and audit readiness in Trial Master File (TMF) with close collaboration with the CTA.
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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.
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Participate in process improvement intiatives limited to your day-to-day scope.
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Interface with vendors (e.g., central labs, CROs) and site personnel as needed and with limited supervision from the study lead (or designee).
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Mentor and support CTAs.
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Support other Clinical Operations activities as appropriate.
Required Skills, Experience and Education:
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BS, BA, or RN in a relevant scientific discipline.
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3-5 years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
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Intermediate knowledge of FDA and EMA Regulatorions, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
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Good communication and teamwork skills.
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Proficient in MS Office and project tracking tools.
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Strong attention to detail and organization, demonstrate reliability and efficiency in supporting clinical trial operations.
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Take the initiative to independently apply knowledge of Clinical Operations.
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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.
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High sense of urgency and commitment to excellence in the successful execution of deliverables.
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Ability to multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
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Travel may be required (~10%).
Preferred Skills:
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Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
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Oncology experience, early and/or late stage, strongly preferred.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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