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Clinical Trials Manager - I

Foster City, CA 94404

Posted: 12/03/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 616360 Is job remote?: No Country: United States

Job Description


Target PR Range: 75-85/hr
*Depending on experience

Job Description - Clinical Trial Manager (CTM)
  • May contribute to development of abstracts, presentations and manuscripts
  • Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
  • Must have a general, functional expertise to support Process development and implementation
  • Provides knowledge and expertise on country specific regulations
  • Participates in and manages project meetings and conference calls with vendors and cross-functional teams.
  • Develops tools and processes that optimize project efficiencies and effectiveness.
  • Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
  • May be required to present at internal or external meetings (i.e., investigator meetings).
  • Leads or otherwise assists in the preparation of interim and final study reports, including resolving any data discrepancies when biomarker data is needed for primary, secondary or support.
  • Proactively identifies potential operational challenges and collaborates with other Clinical Operations colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
  • Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
  • Travel may be required

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. Minimum Education & Experience
  • PharmD / PhD with 2+ years relevant clinical or related experience in life sciences.
  • MA / MS with 3+ years relevant clinical or related experience in life sciences.
  • BA / BS / RN with 5+ years relevant clinical or related experience in life sciences.
  • Meets all requirements for Senior Clinical Trial Management Associate (Senior CTMA) grade 26 position with demonstrable proficiency.

Knowledge & Other Requirements
  • Demonstrated ability to be a fast learner.
  • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
  • Ability to manage any component of full cycle study management, from start-up to close-out.
  • Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
  • Fully understands protocol requirements and effectively articulates and interprets these. Thorough knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
  • Familiar with standard medical / scientific terminology.
  • Experience managing the work of external vendors.
  • Ability to communicate in a clear and concise manner.
  • Ability to support a team-oriented, highly-matrixed environment.

Ability to execute multiple tasks as assigned.
  • When needed, ability to travel.

The staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Foster City, CA

Discover your next career opportunity in the vibrant job market of Foster City, California! Nestled in the heart of the San Francisco Bay Area, Foster City presents a perfect blend of scenic beauty and bustling industry. With top-notch companies, such as Visa and Gilead Sciences, calling this region home, job seekers can find a plethora of growth opportunities in various fields like technology, biotech, and finance. Explore job listings in this charming city known for its picturesque lagoons, beautiful parks like Leo J. Ryan Park, and the iconic Foster City Shell Mound. Indulge in the diverse culinary scene, catch a show at the Hillbarn Theatre, and cheer for the local sports teams like the San Francisco Giants at Oracle Park. Begin your career journey in Foster City today!

Although this hasn't been an issue at Planet Pharma, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.