Junior Clinical Trial Manager

An exciting opportunity has arisen for a Junior Clinical Trial Manager to join a global biopharmaceutical company based in West London. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.

This role offers a high degree of development scope to suitably motivated individuals with excellent communication skills. With a CRO partner, you will drive and manage the start-up, maintenance and close out of 100+ hospital sites across your allocated European countries within a team of 4 others. You will be responsible for the day to day activities, tracking, report, data quality review, vendor liaison, audits and site relationship management. Working closely with the European Clinical Trial Manager, and the Global Study Team, CRO and Medical Affairs, you will contribute to the successful delivery of the trial data on time to quality and budget.

Job Responsibilties:

• 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 Pharmacovigilance and Epidemiology (PVE) to ensure efficient management of study activities.
• Assists in the Management of the CRO's and vendor's 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.
• Clinical trial experience in the pharmaceutical or health care industry or equivalent.
• CRA experience preferred.
• Excellent verbal, written, interpersonal communication
• 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 priorities multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures.
• Resilient profile with the ability to deliver in an ambiguous environment
• Ability to engage and manage multiple stakeholders to achieve the objective
• Curious with learning agility
• Operationally excellent
• Organized with systematic approach to prioritization
• Process orientated to achieve the business objective
• Critical thinker mediating problem solving
• Highly adept at communicating at multiple levels of the organization

To Apply:

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 call Jack O'Neill on +44 203 846 0646 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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