Melanie Miles at CK Clinical is recruiting for a Senior Associate Study Manager for an initial 12 month contract to be based in the Home Counties.
Responsibilities will include:
- Contributing to the preparation and/or review of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets.
- Assisting, contributing to or coordinating preparation and conduct of monitors workshops and investigator meetings.
- Working with the CRSM and country managers to develop recruitment strategies.
- Coordinating study-level investigational product arrangements, accountability and reconciliation.
- Coordinating activities associated with site start-up and management including review of site-modified informed consent forms and tracking of the budget and contract process.
- Providing input for screening and enrolment progress.
- Providing extensive country support by answering operational and protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations).
- Working with BSM and assay groups to coordinate shipment and analysis of clinical biological samples.
- Identifying and consolidating study-related trends and reporting them to the clinical research manager and clinical studies team.
- Identifying barriers to screening and enrolment and provide solutions.
- Supporting and monitoring vendor activities, including relationships and training, and development of vendor specifications and scopes of work.
- Monitoring progress of studies, identifying study-related trends/issues and working with the CRSM to implement corrective actions when necessary.
- Assisting in the processing and distribution of essential documents to the trial master file. Communicating regular updates to countries. Continuing to increase knowledge of clinical research, clinical operations, and relevant therapeutic area.
Qualifications and Skills Required:
- BA/BS/BSc or RN.
- Specialist experience in life sciences or medically related field. Previous biopharmaceutical clinical research experience (clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company).
- Advanced computer skills.
- Experience in interactions with outside vendors.
- Experience with administration of site budgets and grants with supervision. Experience with development of prospective site-selection criteria. Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations. Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
- Ability to write and present clearly using scientific and clinical issues terminology. Experience dealing with time demands, incomplete information or unexpected events. Good organizational and planning skills. Experience working effectively in a team/matrix environment.
How to apply
For more information or to apply for the role please contact Melanie Miles on 01438 743047 or email email@example.com.