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Clinical Trials Operations Manager

2 months ago

Columbia, South Carolina, United States Planet Pharma Full time

Position Overview:

A dynamic biopharmaceutical organization is seeking to expand its team with two Clinical Trial Managers. This role involves collaborating closely with the Head of Clinical Operations (HCC) to oversee the recruitment, initiation, execution, and closure of clinical trials. Additionally, you will play a key role in managing the daily operations of the Clinical Research Associate (CRA) field staff.

Key Responsibilities:

  • Facilitate and monitor site visits for the clinical monitoring team.
  • Coordinate and track project-specific training for field CRA personnel.
  • Review and finalize monitoring visit reports and follow-up communications.
  • Oversee trial start-up activities and manage regulatory documentation to ensure site readiness.
  • Administer the electronic Trial Master File (eTMF).
  • Collaborate with the unblinded CRA to manage clinical supplies.
  • Develop and implement study-specific plans, including clinical monitoring tools and documentation.
  • Ensure compliance with standard operating procedures (SOPs), local regulations, and ICH/GCP guidelines.
  • Participate in the creation of screening and data collection forms.
  • Support the development of Institutional Review Board (IRB) submission packages.
  • Conduct field monitoring and co-monitoring as required.
  • Engage in site qualification, initiation, interim monitoring, and close-out visits as necessary.
  • Evaluate monitors in the field at designated intervals.
  • Oversee study progress and daily operations with site personnel.

Qualifications:

  • Registered Nurse (RN), Radiologic Technologist (RT), or a bachelor’s degree in a science-related discipline, or equivalent experience.
  • Minimum of 5 years of experience in clinical trials or a related field, with over 8 years in the industry.
  • Experience in clinical roles (RN, PA, etc.) with CRA experience is preferred for enhanced field understanding and medical terminology knowledge.
  • Demonstrated experience supporting Phase 2B and Phase 3 studies, particularly with launch experience.
  • Experience working with both sponsors and Contract Research Organizations (CROs).
  • Experience in managing blinded and unblinded Phase 2 and 3 studies, with a focus on blinded studies.
  • Familiarity with therapeutic areas such as neonatal care, respiratory, intensive care, and oncology, with significant study involvement.
  • Proficient in using various Electronic Data Capture (EDC) platforms.
  • Willingness to travel up to 25% domestically and internationally.
  • Able to work onsite as required, with a strong preference for specific locations.
  • Preferred Skills: Experience in clinical supply chain management due to the complexities of drug and device logistics.
  • Background in a startup environment is advantageous.