Ben Traies at CK Clinical is currently looking for an experienced Senior Manager Clinical Operations to permanently join a large global Pharmaceutical company based in Hertfordshire.
As Senior Manager Clinical Operations, your role will involve leading the multi functional study team, co-ordinating activities and working closely with other team members including Therapeutics, Data Management, Biostatistics, Regulatory and Pharmacovigilance. You may also be required to lead study teams for both regional and global studies, which will involve:
- Working closely with and act as coordinator for the cross-functional study team
- Selection and management of CROs and Technical Service Providers (TSPs)
- Ensuring that study is conducted in accordance with ICH/GCP guidelines, local regulatory requirements and SOPs/WPs and in accordance with agreed timelines.
- Ensuring quality of data are acceptable and suitable for regulatory submission.
- Involved in training internal staff and CRO staff for the study (if required)
- May undertake co-monitoring visits with CROs when appropriate
- Communicating effectively with upper management both orally and in writing and set and track the study progress and budget using validated clinicaltrial management tools and systems.
For more information, please contact Ben Traies at CK Clinical on 01438 870021 or email firstname.lastname@example.org.Please quote reference CL22322 in all correspondence.