Planet Pharma

Clinical Trial Management Associate

Planet Pharma Redwood City, CA
Planet Pharma

Clinical Trial Management Associate

Planet Pharma Redwood City, CA
4 days ago 35 applicants

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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

  • 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 intiatives 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.

  • Seniority level

    Mid-Senior level

  • Employment type

    Contract

  • Job function

    Research, Analyst, and Information Technology

  • Industries

    Staffing and Recruiting

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