Our client is a growing Swiss pharmaceutical company that specialises in neuromuscular diseases and other areas of unmet medical need. It is looking to hire a Clinical Trial Manager to join the team in Switzerland on a permanent basis.
Role and Responsibilities:
- Provide clinical operations related input to the Clinical Development Plan
- Ensure that the design of clinical studies under area of responsibility is in line with the objectives defined in the Clinical Development Plan or other relevant plan such as Risk Management Plan
- Develop or coordinate development and approval of study documentation such as the study protocol, ICF, study-specific guidelines, regulatory documents, monitoring, data management and statistical analysis plans and clinical study report, in accordance with internal SOPs and GCP requirements
- Form and lead a cross functional SMT including representatives of appropriate internal or external functions such as Technical Development, Regulatory Affairs, Clinical Science and any expertise required to implement and oversee the study according to GCP, the Protocol and the requirements of the Management Team
- Coordinate the development of specifications for ESPs in collaboration with SMT and ensure appropriate quality control of deliverables
- Contribute to the development of regulatory documents, responses to Health Authority, EC/IRB and DSMB questions
- Oversee study approval processes for Health Authority, EC/IRB approvals for all study document as required
- Plan, organize and lead Investigator meeting and CRA training & review related material
- Resolve issues in a proactive and timely fashion and escalate unresolved issues and identified risks to Head of Clinical Operations and Head of Development as appropriate
- Provide regular study status updates including critical issues to SMT, Development Management and Senior Management as needed
- Create, manage and ensure tracking of study budget including revisions and perform final reconciliation at trial close out
- Oversee database lock activities to ensure timely data availability and coordinate study close out with ESPs as needed
- Coordinate pre-audit and CAPA resolution activities ensuring satisfactory outcome
- Adhere to personal development plan and maintain training records to ensure appropriate level of competence in compliance with this job description including GCP etc
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A full job description is available on request.
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