Contract Senior Clinical Study Management Associate
A vacancy has arisen for a Contract Senior Clinical Study Management Associate with an internationally renowned pharmaceutical company, based in their office in London. This organisation 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. This will be a contract position, running for an initial 12 month rolling period.
- Must meet all requirements for Clinical Trial Management Associate position and have demonstrated proficiency in all relevant areas.
- Provide administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Assist global trial managers with setting up central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
- Perform accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to company SOPs and protocol procedures; review routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- Assist in reviewing protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts, and clinical study reports.
- Assist in compiling of investigator brochures under close supervision.
- Review trip reports generated by CRO CRAs.
- Communicate and collaborate with other functional groups including, but not limited to, Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
- Assist in the Management of the CRO's and vendors as required.
- May be asked to assist in the training of Clinical Trial Management Associates and Clinical Project Assistants.
- Assist with the preparation and organization of international investigator meetings.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
Perform administrative duties in a timely manner as assigned.
- Travel is required up to 20-30%.
Skills and Requirements:
- Typically requires a BSc or BA in a relevant scientific discipline or RN qualification.
- Minimum 3 years of relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- CRA experience preferred.
- HIV experience preferred, but not essential.
- Must be familiar with routine medical/scientific terminology.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision as required.
- 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 Matt 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 Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.