Clinical Trials Management Associate - II
A vacancy has arisen for a Clinical Trials Management Associate - II with an internationally renowned pharmaceutical company, based in their UK office. This organization is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organization and support their innovative impact on the healthcare field.
- Must meet all requirements for Clinical Trial Management Associate position and have demonstrated proficiency in all relevant areas.
- Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Assist global and European trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
- Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to company SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
- May assist in compilation of investigator brochures under close supervision.
- Review of trip reports generated by CRO CRAs.
- Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Pharmacoviligence and Epidemiology (PVE) to ensure efficient management of study activities.
- Assists in the Management of the CROs and vendors as required.
- May be asked to assist in the training of Clinical Trial Management Associates and Clinical Project Assistants.
- Assists with the preparation and organization of international investigator meetings.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Performs administrative duties in a timely manner as assigned.
- Travel is required up to 20-30%, depending on the stage and needs of the clinical trial.
Skills and Requirements:
- Typically requires a BSc or BA in a relevant scientific discipline or RN qualification.
- Minimum 3 years relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- CRA experience preferred and/or experience in a similar role.
- Liver Disease experience preferred but not essential.
- Must be familiar with routine medical/scientific terminology.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials is desirable.
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision as required.
- Must be able to prioritise multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures.
- Demonstrated project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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