Senior Global Clinical Study Manager

CK Group are recruiting for a Senior Global Clinical Study Manager to join a Global Pharmaceutical company at their site based in Berkshire on a permanent basis. This role would allow some home working post-pandemic.

Senior Global Clinical StudyManager Role:

• Lead development of core trial documents & patient facing documents.
• Design and preparation of clinical trials, including definition of trial milestones.
• Ensure provision/provide appropriate trial-specific training of the global trial team and external partners.
• Define the needs for External Service Providers (ESP), identifies and selects ESPs in collaboration with relevant internal stakeholders and oversees vendor services.
• Provide advice on safety aspects and riskbenefit assessments.
• Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical Affairs on Global/Regional level.Your Background:
• University degree in Life Sciences or related field, higher degree/qualification preferred (e.g. MSc, PhD).
• Project management skills including oversight of teams to achieve planned timelines and milestones (4 to 6 years of leadership experience; leading projects).
• Experience ideally in oncology clinical studies.
• Understanding of major regulations (MHRA, FDA, EMA and PMDA).

Apply: For more information or to apply for this Senior Global Clinical Study Manager position, please contact Sam Whyley-Smith on 01246 588040 or email ssmith@ckclinical.co.uk, quoting job ref 49897.

It is essential that applicants hold entitlement to work in the UK.