Senior Manager, Clinical Operations
An international and dynamic biopharmaceutical company is hiring a Senior Manager, Clinical Operations to join their office in Zurich, Switzerland. This organisation is renowned for its work on high-quality biosimilar medicine to help people live longer, healthier and more active lives. This is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Act as the main point of contact for project related discussions (both internally and with external stakeholders).
- Implement, monitor, supervise and direct the assigned Clinical program(s).
- Ensure all program deliverables are met according to timelines, budget, operational procedures and quality / GCP standards.
- Supervise maintenance of Trial Master File (TMF) in strict compliance with ICH/GCP and internal Standard Operating Procedures (SOPs).
- Streamline interactions with relevant internal functions, by leading and coordinating the Clinical Project Team.
- Keep regular interaction with CRO and trial sites to ensure the sponsor's oversight responsibilities.
- Develop clinical outsourcing specifications to facilitate bid templates and selection of clinical research vendors.
- Develop/prepare relevant sections of clinical trial protocols, related documents and clinical sections of regulatory documents, in collaboration with internal stakeholders and CROs.
- Clinical and pharmacovigilance databases reconciliation.
- Support management of clinical trial supply.
- Prepare, conduct and report internal/external meetings.
- Implement and update/improve policies, SOPs and Work Instructions (WIs), as required.
- Up to date with ICH-GCP requirements.
- Responsible for the operational and logistic aspects of the assigned clinical program(s).
- Adhering to regular planning of tasks in accordance with clinical program timelines, performing the required activities to keep the assigned clinical program(s) on budget, on time and with the highest standard of quality.
- The primary point of contact for any program related issue, both internally and with external stakeholders.
- As part of the multifunctional team, the Manager / Senior Manager Clinical Operations is a key function to coordinate activities in the Project Team. Therefore, it is expected that the Manager / Senior Manager Clinical Operations should be able to work independently as well as feel comfortable in coordinating a multifunctional team.
Skills and Requirements:
- Master of Sciences or equivalent.
- Pharm.D. or Ph.D. or equivalent.
- 5+ (Manager) 7+ (Senior Manager) years in relevant functions in the Pharmaceutical Industry, or equivalent.
- Demonstrated ability to interact collaboratively in a cross-functional environment required.
- Subject matter expertise in clinical operations and related activities.
- Previous experience conducting clinical trials in Europe/US or some Asia-Pacific regions in an outsourcing model is necessary, along with a working knowledge of the EMA and FDA clinical/regulatory environment.
- Good knowledge of GCP and other relevant ICH/regulatory guidelines.
- Prior experience in phases 1-3 of clinical drug development as well as a strong operational background, is required.
- Prior experience with the development of biological/biosimilar drugs is desirable, but not essential.
- A proven track record of effective project management is required as well as a high level of communication (written and verbal), interpersonal, organisational and cross-functional collaboration skills are expected.
- Very good knowledge and understanding of Good Clinical Practice (GCP) is a requirement for this role, as well as a very good understanding of Operational aspects associated with the conduct of a clinical program.
- Previous experience in an international Clinical Research Organisation (CRO) is desirable, but not essential.
- Organisation and management skills are required to coordinate, participate and make a positive contribution to team meetings.
- GCP Experience is expected to understand and comply with Good Clinical Practices (GCP).
- Collaboration and interpersonal skills are expected to build team spirit, be tolerant and considerate, be active and open communicator and share knowledge and experience with other team members.
- Proficient in the use of a PC and common Microsoft packages such as Word, Visio, Excel, Powerpoint, MS Project.
- Traveling internationally, as required by the Clinical Trial activities.
- Fluent in English, both written and Any additional language is a plus.
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 contact Lewis Davis at +44 203 078-9569 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.