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Clinical Trials Operations Manager

2 months ago

Columbia, South Carolina, United States Planet Pharma Full time

Position Overview:

**This role will initially be fully remote and transition to a hybrid model in the near future.**

  • Travel Requirements: Occasional travel is necessary, both internationally and domestically, with frequency varying from three times a month to quarterly based on business demands. Internal travel will primarily occur within the UK for Phase 3 studies.

A dynamic biopharmaceutical organization is seeking to enhance its team by adding two Clinical Trial Managers. In this pivotal role, you will collaborate closely with the Head of Clinical Operations and will be accountable for facilitating recruitment, initiation, execution (day-to-day operations), and closure of clinical trials. Additionally, you will assist in managing the daily operations of the Clinical Research Associate (CRA) field staff.

Qualifications:

  • Registered Nurse (RN), Radiologic Technologist (RT), or a bachelor’s degree in a scientific discipline or equivalent professional experience.
  • Over 5 years of experience in the clinical trials sector or a related field, with a minimum of 8 years of industry experience.
  • Preference for candidates with a clinical background (RN, Physician Assistant, etc.) who possess CRA experience, as this is beneficial for field comprehension and familiarity with medical terminology.
  • Previous experience supporting Phase 2B and Phase 3 studies is essential, particularly with launch experience.
  • Experience working with both sponsors and Contract Research Organizations (CROs) is preferred (3/2 split).
  • Experience in supporting both blinded and unblinded Phase 2 and 3 studies, with a primary focus on blinded studies.
  • Experience in therapeutic areas such as neonatal care, respiratory conditions, intensive care, and oncology is ideal, particularly with significant study involvement (not from asthma or allergy backgrounds). Emphasis on drug over device for drug/device combinations.
  • Familiarity with multiple Electronic Data Capture (EDC) platforms.
  • Willingness to travel up to 25% - both internationally and domestically (must possess a valid driver’s license and passport).
  • Able to work onsite three days a week in designated locations, with a strong preference for one specific location.
  • Preferred Skills: Experience in clinical supply chain management, given the complexities associated with drug and device product logistics.
  • Prior experience in a startup environment is advantageous.

Key Responsibilities:

  • Coordinate and monitor visits for the field clinical monitoring team.
  • Track and manage project-specific and Standard Operating Procedure (SOP) training for the field CRA staff.
  • Review, track, and finalize monitoring visit trip reports and follow-up communications.
  • Oversee trial start-up efforts and manage regulatory documents to ensure site readiness for Site Initiation Visits (SIVs).
  • Manage the electronic Trial Master File (eTMF).
  • Coordinate clinical supplies in collaboration with the unblinded CRA.
  • Develop and implement study-specific plans (clinical monitoring plan), monitoring tools, and documentation.
  • Ensure compliance with SOPs, local regulations, and applicable guidelines (CFR, ICH/GCP).
  • Participate in the initial creation of screening and data collection forms, as well as database/data entry screens.
  • Support site-specific development of Institutional Review Board (IRB) submission packages or central IRB submissions.
  • Conduct field/remote monitoring/co-monitoring as necessary.
  • Participate in site qualification, initiation visits, interim monitoring visits, and close-out visits as required.
  • Perform field evaluations of monitors at predetermined intervals or as needed.
  • Oversee study progress and daily operations with sites (Principal Investigators, Coordinators, and other research personnel).