James Joyce Email & Phone Number

Decatur, GA, US

Princeton, New Jersey, US

Direct accountability and responsibility of multiple global Clinical Development Programs in various therapeutic areas (Cardiovascular/Metabolic, Neuroscience, General Medicine) across 24 countries and up to 250 sites in all geographic regions.  Direct responsibility for provision of client deliverables on-time, within budget and scope and with required.

Princeton, New Jersey, US

Led global program team and facilitate team’s ability to lead extended/complete program team in Neuroscience and Cardiovascular/Metabolic Therapeutic Areas. Ensured effective cross-functional teamwork among program team members including both internal and external ancillary services.  Served as escalation point for project issues, resolving conflicts as.

Abbott Park, Illinois, US

Independently manage operational execution for Phase I to Phase IV global clinical study programs in Cardiovascular, Neuroscience and Hormone Therapeutic Areas and the Clinical Pharmacology group. Serve as key point of contact for all external contractors, including Contract Research Organizations (CROs) conducting clinical trials, including alliance.

Worked in The Netherlands as Global head of Clinical Supplies Management Office. Functional oversight of seven direct reports in the Netherlands office and two reports in the US office. Coordinated the supervision of over 120 ongoing clinical trials, providing supplies for any drug trial in operation across the organization for all Phase studies. Ensured.

Management and training of direct report to assist in Clinical Supplies functions. Management and transfer of Clinical Supply functions from an acquired company to the Solvay Clinical Supplies group. Continued management of Clinical Supplies activities in correlation with Clinical Supplies Coordinator.

Management of Clinical Supplies activities for all Phase I-IV clinical studies conducted in the US, consisting of approximately 50 ongoing studies covering over 20 products. Coordination with Clinical Operations personnel and outside vendors to meet clinical supply demands for studies. Drafting and implementing standard operating procedures governing.

Drafting standard operating procedures for department, including procedures governing warehouse management, inventory control, reserve samples inventory, sampling and weighing operations, retesting of materials. Training employees on proper procedures. Management of the R&D facilities warehouse. Inventory control and documentation of all products from.

Pre-Clinical Research and Development ArchiveResponsibilities include documentation and registration of information provided by all departments of Pre-Clinical Research and Development. Pulling information for review by FDA auditors and consultants as needed. Directly report to documentation manager. Responsible for training other temporary employees in.

Mph, Outcomes Research

Bs, Physics, Astronomy, Mathematics