Purpose of the role:
Planning and implementation of all operational aspects of assigned medicine studies (e.g. medium to high complexity studies; first in man, patient studies, multi-center studies, mechanistic studies) from synopsis to reporting according to timelines, budget, operational and quality standards.
Responsibilities:
Writing clinical protocols and related documents in collaboration with the Clinical trial Team (CTT)
Lead the clinical trial protocol development process
Lead and matrix manage the global CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
Function as a Clinical Program Manager 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.
BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD.
Languages: Fluent English (oral and written), knowledge of a second language is desirable.
Experience / Professional Requirement:
1. Gained relevant experience (preferred at least 2 years) in Translational medicine, Clinical Research or Research Nurse experience (CRO, academic institution, hospital or industry), as judged from CV/interview
2. Potential to cope with both scientific aspects and operational tasks in a multidisciplinary organization (teamwork).
3. Knowledge of drug development process.
4. Capable of clear written and verbal expression of ideas, an active/proactive communicator.
Key Words:
"clinical project leader" "clinical project head" "clinical trial leader" "clinical trial head" "clinical trials" "study delivery leader" "global study leader" "SDL" "GSL" "CPL" "CTH" "CTL" "pharmaceutical" "biotech" "pharmaceuticals" "biotechs" "CRO" "clinical research organisation" "clinical project leader" "clinical research" "clinical R&D" "clinical development" "clinical research and development" "ich gcp" "ich-gcp" "CPM" "SCPM" "Programme Management" "Project Manager" "program manager"