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Clinical Trial Manager / In-House Sr. CRA

Redwood City, CA 94063

Posted: 03/26/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 603446 Is job remote?: No Country: United States

Job Description


Clinical Trial Manager/In-house Sr. CRA - CTM 

The Opportunity:


This is a unique opportunity for an experienced Clinical Operations Professional who has technical expertise in managing Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) regulatory requirements. Oncology experience is preferred. As the Clinical Program Manager/Sr. Clinical Program Manager of Clinical Operations, initially reporting to the Associate Director/Director Clinical Operations, you will be responsible for Contract Research Organization (CRO) oversight and execution of clinical studies.

Specifically, you will be responsible for:

  • Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives.

  • Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines.

  • Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, Electronic Data Capture (EDC) provider, and independent contractors) to execute clinical trials.

  • Reviewing and contributing to the development of study-specific documentation including clinical trial protocols, case report forms, study guides/manuals, informed consent forms and clinical database.

  • Reviewing monitoring reports and other study documentation as required.

  • Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).

  • Participation in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.

  • Following up on assigned team action items and identification, escalation, and resolution of issues as needed.

  • Collaboration with contracts specialist to review and negotiate Clinical Trial Agreements and site specific study budgets.

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

  • Development of clinical study monitoring priorities and Monitoring Plan in conjunction with CRO.

  • Conduct site visits (e.g., training visits, site initiation visits, monitoring visits), as required.

  • Managing investigational product accountability and reconciliation process.

  • Assistance with the preparation of safety, interim and final clinical study reports, and resolution of data discrepancies.

  • Providing clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies.

  • Preparation and tracking of study participant enrollment projections vs. actuals and study budgets.

  • Serving as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.

Required Experience, Skills, and Education:

  • BS or MS degree with a minimum of 5+ years clinical operations experience in the pharmaceutical or biotech industry, preferably the majority in oncology drug development

  • Hands-on experience of running early-stage clinical trials within an industry environment.

  • Experience of clinical trial operations outside the USA is desirable, but not essential.

  • Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.

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

  • Experience in working with cooperative group studies and investigator sponsored trials, preferred.

  • A demonstrable record of strong vendor management and teamwork.

  • Direct experience of managing clinical CROs.

  • Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

  • Excellent written and verbal communication skills.

  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.

  • Ability to travel (~25%).
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