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Job Description

Company Name:                                              PPD Development, L.P.

Position Title:                                                   Clinical Team Manager

Location:                                                           929 North Front Street, Wilmington, NC 28401

Summary of Duties: Accountable for achieving clinical deliverables, including cleaning data from evaluable patients as specified in the study protocol. Interpret data on complex issues and makes good business decisions with support from line management. 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 high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities, including processing improvements, managing complex programs, and having wider management or project coordination responsibilities. Develop clinical tools, including Monitoring Plan and 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 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 period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, and 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 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. This role requires independent travel up to 20% including domestic and international.

Qualifications: Bachelor degree in Healthcare Management, Pharmaceutical Science, Chemistry, Biochemistry, Medical Biology, or related field and five (5) years of experience as a Clinical Research Associate, Site Manager, Project Manager, or related role. Must have three (3) years of experience with: Practices, processes, and requirements of clinical monitoring; Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management; Relevant regulations, including ICH/GCP, FDA guidelines, and local regulations; Independently managing clinical only studies; Navigating and oversight activities for systems such as Clinical Trial Management System; Oversight of quality and audit readiness with supportive systems for assigned studies; and Technical experience with Electronic Data Capture system, Query Management and Data Analytic Reports. Must have one (1) year of experience with: evaluating own and team members workload against project budget and adjust resources accordingly.

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