Senior Associate Study Management
Russell Oakley at CK Clinical is recruiting for a Senior Associate Study Management to join a company in the pharmaceutical industry at their site based Uxbridge on a contract basis.
The main purpose of the role will be to:
- Contribute to the preparation and/or review of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets.
- Assist in the identification of/identify clinical trial investigators. Contribute to or coordinate preparation and conduct of monitors workshops and investigator meetings.
- Work with the CRSM and CRAs to develop recruitment strategies.
- Coordinate study-level investigational product arrangements, accountability and reconciliation. Participate in and support study teams.
- Coordinate activities associated with site start-up and management including review of site-modified informed consent forms and tracking of the budget and contract process.
- Provide input for screening and enrollment progress. Provide extensive clinical site/CRA support by answering protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations).
- Work with BSM and assay groups to coordinate shipment and analysis of clinical biological samples.
- Identify and consolidate study-related trends and report them to the clinical research manager and clinical studies team.
- Identify barriers to screening and enrolment and provide solutions. Support and monitor vendor activities, including relationships and training, and development of vendor specifications and scopes of work.
- Using relevant reports, identify progress of CRF data collection and query resolution.Monitor progress of studies, identify study-related trends/issues and work with the CRSM to implement corrective actions when necessary.
- Provide input to the clinical studies team for the creation of clinical study timelines and budgets. Assist in the processing and distribution of essential documents to the trial master file.
- Communicate regular updates to CRAs and other study staff. Support preparation and quality control of clinical study reports.
- Continue to increase knowledge of clinical research, clinical operations, and relevant therapeutic area.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- BA/BS/BSc in the sciences or RN. Broad experience in life sciences or medically related field, including general biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company.
- Knowledge: Ability to understand technical, scientific and medical information.
- Understanding of drug development process.
- Familiar with advanced concepts of clinical research. Advanced computer skills. Experience in interactions with outside vendors, e.g., CROs and contract labs.
- 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
This is an excellent opportunity to join a Global Pharmaceutical company
For more information or to apply for this position, please contact Russell Oakley on 01246 45 77 33 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL31308 in all correspondence.