Dee Ward Email & Phone Number

Leland, NC, US

Durham, North Carolina, US

Responsible for the development of clinical trial agreements, contracting strategies and negotiation parameters to support the global site contracting processes.Develops contract and contracting systems, tools, processes, and training materials for selected sponsors and complex studies or multi-protocol programs.Ensure collaboration, including.

Durham, North Carolina, US

Responsible for the development of clinical trial agreements, contracting strategies and negotiation parameters to support the global site contracting processes.Develops contract and contracting systems, tools, processes, and training materials for selected sponsors and complex studies or multi-protocol programs.Ensure collaboration, including.

Wilmington, NC, US

Provides regional oversight, contractual risk assessment in accordance with established PPD contractual considerations, liaise, through established channels, with PPD’s Legal Department, during country process improvement initiatives.Acts as regional subject matter expert in review of Investigator Contracts training materialsProvides, prepares/approves and.

Wilmington, NC, US

Direct supervisor of 12+ employees. Responsible for results interms of cost, methods and personnel. Full accountability for hiring, discipline, discharge,performance appraisals, salary administration, etc.Drafts and negotiates Sponsor-approved Clinical Trial Agreement templates; Reviews, drafts andnegotiates Clinical Trial Agreements; Serves as a liaison.

Wilmington, NC, US

Draft, negotiate and finalize Clinical Trial Agreements; serves as a liaison between Sponsor and study site; identifies and protects Company from unnecessary business and legal risks; implements and manages an efficient process for internal approval and execution of Clinical Trial Agreements; ultimately responsible for the quality of the Company’s Clinical.

Wilmington, NC, US

Manage preparation, review, negotiation and finalization of budget and payment schedule terms and conditions with clinical study sites and principal investigators (“Clinical Trial Agreements”) within the pre-established study specific timelines while ensuring the parameters set by PPD and/or PPD’s clients are fully met. The primary purpose and objective.

Wilmington, NC, US

• Organize, manage and evaluate clinical administration activities and the performance of clinical administration personnel, including hiring, implementation of applicable training, and conducting employee performance.
• Analyzes and manages clinical administration portion of Business Development bids and contracts for multiple studies within specific division(s). Participate in monthly budget meetings. Initiate, develop and assure.
• Organize, manage and coordinate aspects of non-clinical /clinical study start-up as new projects are awarded, including: determination of appropriate staffing; development of regulatory and financial packets, set-up of.
• Coordinate review of regulatory documents for proper and accurate content prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the Client. Manage drug accountability (if required) by.
• Coordinate shipment of investigational product and clinical supplies to investigative sites in accordance with sponsor directives, including acting as a liaison with client-determined vendors.
• Communicate with client and vendors regarding study issues and promotes a collaborative relationship between client and PPD.

Wilmington, NC, US

• Performed and coordinates study activities associated with clinical trials to ensure applicable timelines and metrics are met, including all regulatory, legal and financial aspects in accordance with FDA GCPs, ICH.
• Developed collaborative relationships with CRAs, investigative sites and client company personnel.
• Accountable for the review and transmission of regulatory documents and negotiation of budgets and investigator grants.
• Possessed the ability to conduct investigator file reviews.
• Ability to review and retain knowledge of the protocol.
• Accountable for generating, resolving and clarifying queries and regulatory documents.

Wilmington, NC, US

• Coordinated and assigned workload for Records Management staff.
• Provided Document Technicians with work direction.
• Maintained, organized, and filed regulatory records for multiple projects and projects to assure file security, document control and consistencies with working practices that comply with FDA, Client Company, PPD.
• Coordinated the workload and budget hours for records management personnel.
• Trained and mentor Document Technicians, Sr. Document Technicians, other Records Management Coordinators and temporary employees.
• Assisted with project-specific responsibilities as needed.