Global Clinical Trial Associate (CTA)/Clinical Manager (CM)

For our Life Sciences client in Switzerland, we are seeking for a Clinical Trial Manager.

Job title: Clinical Trial Manager - Oncology

Location: Basel, Switzerland

YOUR ROLE:

- Manage all aspects of assigned Regional clinical trials as Clinical Manager, including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials.
- Support writing of clinical protocols and related documents in collaboration with the Franchise Medical Directors, and/or MSE,: manage the clinical trial protocol development process; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards.
- Forecast trial resources needs (internal and external costs): Supports the COM for the development, management and tracking of trial budget working closely with the appropriate groups in Oncology (eg Finance, CRO management). Accountable for accuracy of trial information in all trial databases and tracking systems.
- Contribute to the development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, submission documents, responses to Health Authorities questions.
- Accountable that program specific standards (eg, CRFs, outsourcing specifications, data monitoring and validation plans) are developed and applied across all trials to ensure consistency of clinical dossier.
- Responsible for implementation of best practices and standards for trial management, including sharing lessons learned.

YOUR EXPERIENCE:

EDUCATION: Advanced degree or equivalent education/degree in life science/healthcare is strongly recommended.

EXPERIENCE:

-3-5 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 Oncology and/or Haematology is preferable.

We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.

We hope that the role will be of interest to you and understand that further information may be required prior to an application to the end client, please feel free to email or call me at anytime with any questions you may have. Alternatively I am contactable via an open-link on LinkedIn.

Looking forward to hear from you soon,

Kind regards,

Neha Sharma

Pharmaceutical & Life Sciences Business Developer

Michael Bailey Associates

Michael Bailey International is acting as an Employment Business in relation to this vacancy.