We have an exciting opportunity for an office based Senior Clinical Program Manager working in Neurosciences for our large global pharmaceutical client.
Summary:
Accountable for all aspects of assigned CD&MA clinical trials (Phase II through lifecycle management) including leading Clinical Trial Team(s). Number of clinical trials depends on the workload and complexity of the individual trials. Responsible for program level activities as assigned.
Responsibilities:
Writing clinical protocols and related documents in collaboration with the Clinical trial Team
Lead the clinical trial protocol development process
Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
Function as a Lead trial leader on studies for Full Development and assist in the coordination of TM related submission documents.
Responsible for ordering and management of clinical trial materials
Identify sites and manage study set-up
Support the CRA on study related questions and serve as point of contact for managing/ answering questions relating to trial procedures and subjects eligibility
Responsible for set up and maintenance of the Trial Master File for assigned studies
Regularly update all trial information databases in order to manage accuracy of information
Approve for all necessary center payments
Lead the ongoing review of the clinical trial medical/scientific data (as needed), analysis and interpretation including the development of first interpretable results, clinical trial reports, publications and internal/ external presentations.
Co-ordinate pre-audit activities for nominated projects
Contribute to identification and evaluation of new centers suitable for performing TM studies in healthy volunteer and patients.
Requirements:
CANDIDATES MUST HAVE PROTOCOL WRITING EXPERIENCE
Education:
Advanced degree or equivalent education/degree in life science/healthcare is required. MD, PhD preferred.
Languages:
Fluent English (oral and written)
Experience:
* ≥ 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
* Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote).
* Experience in developing effective relationships with key investigators.
* Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
* Advanced knowledge of the assigned Therapy Area is preferable.
* Previous experience within a local medical organisation is preferable.
Keywords:
"Clinical Project Leader" "Clincal trial leader" "CPM" "Clinical Project Manager" "Clinical Programme manager" "Study Manager" "SCPM" "Programme manager" "Clinical Development" "Respiritory" "Clinical Trial Head" "CTH" "Protocol" "Global study leader" "Oncology"