Clinical Trial Management Associate

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.