Senior Clinical Trial Manager - Switzerland, United Kingdom - CK GROUP

CK GROUP

Verified Company

Switzerland, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 accordingto 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 CHF

Apply:

Entitlement to work in Switzerland is essential. Please quote job reference 54968 in all correspondence.