CK Clinical are recruiting for a Senior Clinical Trial Manager, Early Phase to join a well established and successful pharmaceutical company in Switzerland. This will be a hybrid role, office based in Vaud for three days per week.
RESPONSIBILITIES:
As Senior Clinical Trial Manager, Early Phase you will contribute to delivering new medicine to the market through planning, leading and delivering international Phase I & II clinical trials in Oncology. You will ensure that your studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.
Key duties will include:
- Leading the overall initiation, coordination, implementation and management of international clinical trials at different stages during mission duration
- Leading the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
- Managing operational and technical aspects of projects including budgeting, timelines and risk management
- Managing and coordinating external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
- Establishing study milestones and ensuring accurate tracking and reporting of study metrics and timelines
- Ensuring the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company?s specific SOPs
- Providing operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents
- Design, review and approve of all trial related documentation, and establish trial processes
QUALIFICATIONS:
As Senior Clinical Trial Manager, Early Phase you will require:
- BSc in Life Sciences
- Proven experience of managing early phase Oncology studies in a sponsor company
- Experience in pharmacokinetic studies (eg DDI, ADME) will be useful
- Experience of managing and filing Trial Master Files (Veeva Vault knowledge is a plus)
- Strong negotiation skills, scientific knowledge and involvement
- Experience of contributing to protocols and clinical development plans
BENEFITS:
Salary around CHF165.000
Apply:
Entitlement to work in Switzerland is essential. Please quote job reference 54968 in all correspondence.
You must have the right to work in Switzerland.
- Agency: CK Group
- Reference: 54968
Website: CK Group
- Posted: 6th March 2023
- Expires: 3rd April 2023
