Clinical Data Manager - CRO

Posted 14 November 2023
Salary Negotiable
LocationUnited States of America
Job type Contract
Discipline CRO & Clinical Operations
Contact NameNikhil Akkoo

Job description

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.