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Sr. Clinical Trial Management Associate (Senior CTMA)

San Mateo, CA 94404

Posted: 02/26/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 597228 Is job remote?: No Country: United States

Job Description


POSITION OVERVIEW:

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas. Clinical Operations plays a key role in ensuring all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of products.

You will support other Clinical Operations team members in the start-up, maintenance, and close-out of clinical studies. You may manage certain components of clinical studies and act as a member of the study team. You may also manage vendors and/or manage investigator-sponsored research. You may assist in the review of clinical study protocols and other study documents, contribute to SOP development and/or participate in special projects. EXAMPLE RESPONSIBILITIES:
  • Leads or manage components of Phase I, II or III studies
  • Assists Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinates all interactions and deliverables from vendors.
  • May assist as operational contact for studies
  • Plans and coordinates all operational activities required with the collection, delivery and analysis of biological samples within a clinical trial
  • Manages study timelines, including documentation and communications
  • Serves as the point of contact with internal and external stakeholders for successful implementation of all biological sample analysis strategy in client and Collaborative (CO) programs
  • Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.
  • Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting.
  • Participates in the review and approval of main study and optional informed consents, and may review additional study specific informed consents
  • Contributes to SOP development and/or participates in special projects
  • Develops tools and processes that optimize project efficiencies and effectiveness.
  • Proactively identifies potential operational challenges and collaborates with key stakeholders to provide solutions to ensure study execution remains on track to projected budgets and timelines.
  • Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

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
  • MA/ MS / PharmD / PhD with 2 + years relevant clinical or related experience in life sciences.
  • BA / BS / RN with 4 +years relevant clinical or related experience in life sciences.
  • Experience in managing the work of external vendors.
  • Meets all requirements for Clinical Trial Management Associate (CTMA) grade 25 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.
  • Knowledge of full cycle clinical study management, from start-up to close-out, and has shown ability to effectively apply this knowledge to achieve targeted study outcomes.
  • Significant industry knowledge.
  • Complete knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
  • Familiar with standard medical / scientific terminology.
  • 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 and The Planet Group of Companies are equal opportunity employers. 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 San Mateo, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Mateo, California area today! Located in the heart of the Bay Area, San Mateo offers a perfect blend of picturesque landscapes, bustling tech industry, and a rich cultural scene. From the iconic Coyote Point Park to the bustling downtown with its array of dining options, art galleries, and theaters, there is something for everyone here. With proximity to professional sports teams like the San Francisco Giants and Warriors, as well as easy access to the stunning Half Moon Bay and Pacific Ocean beaches, San Mateo provides a unique backdrop for career growth and personal enjoyment. Don't miss out on the chance to make your mark in this dynamic and inviting community!

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.