Sr. Clinical Team Manager

at  Thermo Fisher Scientific

JOB DESCRIPTION

Company Name: PPD Development, L.P.
Position Title: Sr. Clinical Team Manager
Location: 929 North Front Street, Wilmington, NC 28401
Summary of Duties: Interpret data on project issues and make good business decisions with minimal support from experienced team members or line manager. Work to ensure that all clinical deliverables meet the customer’s time, quality, and cost expectations. Maintain profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Manage all clinical operational and quality aspects of allocated studies, of moderate to complex complexity, in compliance with ICH GCP with minimal oversight. 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). 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 deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of 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 or co-monitor clinical trials to assess performance and ensure contractual obligations are met. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follow up on all questions raised by the ethics committees. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements. Duties may be performed remotely. 20% domestic travel.
Qualifications: Master’s degree in Biotechnology, Biology, Pharmaceutical Science, Clinical Research, or related field, and five (5) years of experience as a Clinical Trial Manager, Clinical Research Associate, Study Coordinator, or related role. Employer will also accept a Bachelor’s degree in Biotechnology, Biology, Pharmaceutical Science, Clinical Research, or related field, and eight (8) years of experience as a Clinical Trial Manager, Clinical Research Associate, Study Coordinator, or related role. Must also have Five (5) years of experience with: Clinical monitoring; Relevant regulations, including ICH/GCP and FDA guidelines; Oversight activities for systems such as CTMS, EDC, and ePIP. Four (4) years of experience with: Budgeting, forecasting, and fiscal management.

Please refer the Job description for details