Mantell Associates are thrilled to have partnered with a mid-sized, global CRO who partner with a huge variety of pharmaceutical and biotechnology sponsors across phases I through IV. They are looking for several additions to their US Statistics department, to support their client's clinical trial design and analysis, including a Clinical Data Manager to join for 12 months on a contract basis.
Clinical Data Manager - Responsibilities:
Provides expert review of study designs, analysis plans and reports.
Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing statistical analysis plans.
Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management
Clinical Data Manager - Requirements:
Msc / PhD plus 7+ years Data Management experience ideally within a CRO environment
Expert in a broad range of EDC's across all phases (I to IV) of Clinical Research
Veeva experience is a plus
Knowledge of FDA, CLIA or other regulatory guidelines is an asset
Thorough knowledge of regulatory standards, SAS and other software applications
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.