Senior Clinical Data Manager
Our client is a leading international CRO currntly opperating out of Europe and the US. The are well established and have a very exciting, unique approach to their clinical research.
Core Responsibilities:
Provide professional management and coordination of clinical trial data, on both an individual trial and project level (Phases I to IV). Identify errors and inconsistencies in CRF data and ensure their resolution in order that databases can be declared clean and locked according to ICH GCP standards.
• Perform role of Clinical Data Manager (as outlined in Clinical Data Manager job description).
• Ensure tasks documented in the study contract are completed on time and be able to assist monitoring the project budget and resource.
• Respond to requests made by the Sponsor for information or presentations such as workshops and project planning meetings as appropriate.
• Communicate effectively with the Sponsor via e-mail, telephone conferences, presentations etc in order to fully manage and lead the project or trial.
• Train, coach and mentor Clinical Data Associates I/II and Clinical Data Managers. Conduct departmental training workshops or presentations as required.
• Participate in, and support and Business Development activities, i.e. bid defence meetings etc.
Essential Work Experience and Qualifications:
• Degree in life sciences, pharmacy, nursing or nursing qualification (e.g. RGN) or equivalent relevant experience.
• Typically 4 or more years experience in drug development, at least 2/3 years in the discipline of data management.
• Foreign language skills would be advantageous.
Key Words: Clinical Trials Data Management Surrey Manager International CRO ICH GCP