Clinical Trial Manager
ProClinical is seeking a Clinical Trial Manager for a biotechnology company based in Zurich on a permanent basis. The Clinical Trial Manager will be accountable for all aspects of the management and clinical execution of early phase clinical trials within Translational Medicine (TM). The Senior Clinical Scientist (SrCS) leads the planning and implementation of all operational aspects of TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).
- Clinical Scientist for Phase I/II including multi-country / multi-centre trials. The main focus will be on high complexity studies
- Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team and support functions to ensure all trial deliverables are met. Chair Clinical Trial Team meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards.
- Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.
- Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects' eligibility.
- May support the Medical Expert on project documentation e.g. briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.
- Lead the ongoing medical /scientific review of the clinical trial data, coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations. Direct the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are available in a timely manner.
- Accountable for Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements.
- Accountable for the set up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.
- Contribute to the evaluation of clinical sites and external service providers for performing TM studies in healthy volunteers and patients.
- Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.
- Oversee and coordinate the work of assigned support Clinical Trial Associate(s) and Clinical Scientist(s) at the study/project level ensuring clear delegation/assignment of duties are documented.
- Identify and help implement areas for process improvements.
- Active participation in on-boarding, training and mentoring activities of new CS&I or TM hires. In collaboration with CS&I management, contribute to the hiring/interview process for new CS&I or TM hires.
- Responsible for implementation of best practices and standards for trial management within TM, including sharing lessons learned.
- Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies. Assist or perform training for CTAs and Clinical Scientists.
Skills and Requirements:
- 6+ years' experience in clinical trials
- Extensive knowledge of GCP.
- Track record of managing multiple Early phase studies & complex clinical trials.
- Demonstrated leadership and problem-solving skills.
- Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills.
- Clear written and verbal expression of ideas, an active/proactive communicator.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Valaince Penteng on +44 203 8460 643 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.