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Sr. Clinical Trial Manager

Redwood City, CA 94063

Posted: 04/07/2025 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 618702 Is job remote?: Yes Country: United States

Job Description


Clinical Trial Manager - CTM
 

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional. As a Clinical Trial Manager (CTM) / Sr. Clinical Trial Manager (Sr. CTM), you will be responsible for acting as a central contact for the clinical study team(s) and assist with the execution and clinical trial CTM Responsibilities (will also need to meet the General Responsibilities):

Sr. CTM Responsibilities (will need to meet all responsibilities [General and CPM]):

  • Identify, engage, and manage the activities of contract research organizations (CROs) and other clinical trial vendors (e.g., Interactive Response Technology (IRT), imaging vendor, central labs, etc.) as well as serve as liaison between internal team members, investigative sites, and CROs.

  • Support the study lead in the management of clinical study timelines and budget by utilizing appropriate project management tools, identify and select vendors, manage vendor contracts and ensure budgets are within department guidelines.

  • Co-lead team meetings and collaborate with cross-functional groups within the clinical study team (e.g., Clinical Data Science, Clinical Development, Pharmacokinetics, Regulatory, etc.) to achieve clinical trial goals.

  • Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.

  • Assess adequacy/feasibility of potential clinical investigators and sites, including qualification of investigators, evaluation of facilities, personnel, patient referral base, and adherence to GCP.

  • Review and identify trends when performing routine data surveillance of data listings, and support in the preparation of interim and final Clinical Study Reports and resolution of data discrepancies.

  • Provide support, mentorship, guidance, and direction to Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs), as appropriate.

  • Actively contribute in development of internal business documents (e.g. SOPs, Clinical Study Reports, Investigational New Drugs (INDs), New Drug Applications (NDAs), and other Clinical, Regulatory, Safety documents) with minimal supervision.

  • Support other Clinical Operations activities as appropriates.

Required Skills, Experience and Education:

  • RN or Bachelor’s degree in biological sciences or health-related field required.

  • 5+ years (CTM) or 7+ years (Sr. CTM) direct experience preferred and/or relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.

  • Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

  • Experience in selection of CROs/vendors and management of external resources.

  • 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.

  • Excellent written/verbal communication and interpersonal skills.

  • High sense of priority and commitment to excellence in the successful execution of deliverables.

  • Ability to analyze operational data, perform with an emphasis on quality, timeliness and multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.

  • Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

  • Travel may be required (~15%).

Preferred Skills:

  • Decision-making skills

  • Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

  • Oncology experience, early and/or late stage, strongly preferred.

  • Knowledge and/or familiarity with EMEA/APAC region(s) clinical trial operations.

  • Attention to detail.

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 Redwood City, CA

Ready to embark on an exciting career opportunity in the vibrant area around Redwood City, California? Nestled in the heart of Silicon Valley, this thriving region offers a perfect blend of innovation, growth, and charm. From the bustling tech scene to the serene beauty of Redwood City's parks, like Edgewood Park and Pulgas Ridge Preserve, there's something here for everyone. Immerse yourself in the local culture by visiting the Fox Theatre or exploring art galleries like The Art Center and Redwood City Art Kiosk. With a bustling food scene offering everything from trendy cafes to authentic Mexican cuisine, it's no wonder that Redwood City is a top choice for job seekers looking to thrive in a dynamic environment. Browse our job listings today and take the next step towards a fulfilling career in this captivating locale!

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.