Trials Manager

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Detailed job description and main responsibilities

For further information on this role, please see the attached detailed Job Description and Person Specification:

• Coordinate the set-up and conduct of clinical trials and clinical research projects.
• Contribute to clinical trial design, protocol development and funding applications together with CI, statistician and other members of the team, under the supervision of Senior Trial Managers and Project Managers members.
• Input into clinical trial protocols, prepare funding applications for new study proposals and prepare clinical trial budgets, under the supervision of the senior team members.
• Contribute to preparation of essential clinical trials documents, including protocol, patient information sheets in collaboration with Chief Investigator (CI), Senior Trial Manager, Clinical Fellow etc.

Person specification

Education/Qualifications

Essential criteria

• Educated to degree level or equivalent experience

Desirable criteria

• Higher degree qualification (e.g. MSc) in a relevant subject, preferably in the medical or biological sciences.
• Project Management qualification (e.g. PRINCE 2)

Experience

Essential criteria

• Experience of working to UK clinical trials regulations
• Previous clinical trial experience - ideally with protocol development, reporting, and archiving
• Experience of working in a clinical research environment within NHS, University or pharmaceutical industry
• Experience of preparing REC submissions
• Experience of working across organisational boundaries with multidisciplinary teams
• Experience of communicating effectively with all levels of staff - written and verbal
• Clear understanding of and interest in cancer research
• Proven problem solving skills.
• Excellent presentation skills

Desirable criteria

• Experience of developing and implementing new SOPs and processes
• Experience of preparing REC, HRA, MHRA, IRMER and other submissions
• Experience working on complex clinical trials with Investigational Medicinal Product
• Experience of regulatory inspections

Skills/Knowledge

Essential criteria

• Knowledge of UK Clinical trial regulations, GCP and regulatory framework
• Knowledge of the requirements of clinical trials and clinical research projects during their life cycle especially at the start-up stage
• Knowledge of systems and processes required to conduct clinical trials in accordance with clinical trials regulations
• Knowledge of clinical trial design issues in conducting oncology studies
• Understanding of the clinical trials approval process to conduct clinical research in the UK
• Proficient in the using PC based Windows and Microsoft Office

Desirable criteria

• Knowledge of database set-up and data management processes and procedures necessary to conduct clinical trials
• Knowledge of Clinical trial methodology and/or statistical issues as they pertain to clinical trials
• Knowledge of developing budgets for clinical trials including AcORD process
• Knowledge of Visio

Other Requirements

Essential criteria

• Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately.
• Maintain a positive and enthusiastic attitude towards tasks and their goals.
• Ability to work well within a multi-disciplinary team environment in an effective and supportive way.
• Able to work under pressure, methodical in approach, with effective problem-solving ability
• Ability to work effectively to tight deadlines under direction and on own initiative
• A high level of accuracy and attention to detail
• Flexible attitude and capable of dealing with changing working conditions