Senior Clinical Team Manager

General Information

• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office

Company and Position Details

• Company Name: PPD Development, L.P.
• Position Title: Senior Clinical Team Manager
• Salary: $139,207.70 per year
• Location: 929 North Front Street, Wilmington, NC 28401

Summary of Duties

• Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP.
• May assume Lead CTM responsibilities on a regional level, Clinical Study Manager (CSM) responsibilities, or take on additional responsibilities such as process improvements, managing complex programs, or project coordination responsibilities, in accordance with project-specific requirements.
• Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
• Contribute to the development of the Master Action Plan (MAP) for providing clinical-related documents.
• Ensure timely set up, organization, content, and quality of the relevant sections of the Trial Master File (local and central).
• May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required.
• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborate with the clinical team and other departments as needed to meet project deliverables.
• Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained.
• Implement and train for standardized clinical monitoring processes within the study and according to corporate standard policies.
• Archive documents and study materials for the department.
• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
• Continuously monitor clinical trials to assess performance and ensure contractual obligations are met.
• May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• Communicate with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues.
• May coordinate all start-up activities and ensure that essential document quality meets the expectation of Regulatory Compliance Review.
• Ensure timely regulatory submissions (if appropriate) are addressed.
• Review and follow up on all questions raised by ethics committees.
• Provide input into preparation of forecast estimates for clinical activities.
• Responsible for clinical resource management, assignment, delegation of clinical responsibilities, and identification of additional resource requirements.
• Duties may be performed remotely.
• 20% domestic travel is required.

Qualifications

• Education: Bachelor’s degree in Biology, Biotechnology, Pharmaceutical Science, Chemistry, Biochemistry, Healthcare Administration, Pharmacology, or related field.
• Experience:
  • Eight (8) years of experience as a Clinical Research Associate, Trial Manager, Project Manager, Clinical Lead, or related role.
  • Six (6) years of experience with:
    • Clinical monitoring or clinical site support.
    • Regulations such as ICH/GCP, FDA guidelines, and local regulations.
  • Four (4) years of experience with: Working with project budget and adjusting resources accordingly.
  • Three (3) years of experience with: Global experience in managing clinical trials and study teams across regions.