Job Description
Our client, a young science driven pharmaceutical company with early stage product development pipeline, now seek a Clinical Data Manager to manage multiple clinical projects/programs transferred by the development company to CROs and other vendors to GCP standards.
The Clinical Data Manager will be responsible for providing comprehensive data management expertise (including all operations tasks and Data Management Plan generation, oversight and approval) while overseeing data management activities to ensure that the Project Team expectations are understood, timelines are met and quality data delivered.
Person fit: Ideal candidate will be a Clinical Professional who is self-driven and capable of working on their own initiative in a fast paced dynamic environment.
Responsibilities of Clinical Data Manager:
Manage all aspects of the clinical trial data management process from study start-up to database lock for their clinical trials.
Serve as a member of Clinical Study Teams and act as primary Data Management contact and contributor for assigned projects.
Oversee CROs, EDC vendors and other third-party vendors in a project manager capacity in support of timelines and data-related deliverables.
Monitor timelines and ensures that clinical data management deadlines are met with quality.
Perform UAT for database and test according to UAT Plan.
Specify requirements for data management documentation, electronic and manual edit checks created by CRO.
Review and approve electronic and manual edit checks created by third party vendors.
Review and approve data management documentation created and maintained by third party vendors.
Ensure that all medical coding is performed on an ongoing basis throughout the life cycle of the program and at the end prior to database lock.
Ensure the proper data transfers are conducted (central lab data, ECG data, patient reported outcome data, etc.).
Create and maintain electronic and manual edit check specifications for internal studies.
Create and maintain data management documentation for internal studies.
Oversee the review of clinical trial data to identify erroneous, missing incomplete, or implausible data.
Review and provide feedback on protocols.
Ensure adherence to data management standards.
Provide written and/or verbal status reports to department and project team.
Provide data management input to Requests for Proposal.
Review vendor proposals, work orders and contracts.
Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements.
Manage multiple projects.
Identify and troubleshoot operational problems, issues, obstacles and barriers for studies based on metrics data, and input from project team members.
Participate in the development and maintenance of SOPs and Work Instructions related to data management activities.
Investigate, evaluate and implement new technology solutions.
Requirements for Clinical Data Manager:
8+ years of related experience in clinical data management in the pharmaceutical / biotechnology industry or equivalent.
Oracle Clinical / Inform/ and/or Rave -Remote Data Capture (OC/RDC) experience as well as relational database and report development experience, including basic SQL knowledge.
Knowledge and understanding of regulatory guideline for use of computer systems in clinical studies.
Demonstrated knowledge of GCPs, ICH guidelines, CFR Part 11 and computer systems validation.
Proficiency with web-based EDC systems experience require.
Experience with IVRS/IWRS systems preferred.
Have an understanding of SAS programming, SDTM and ADaM reporting requirements is preferred.
Demonstrates ability to build and maintain effective relationships with others and establish collaborative partnerships with internal and external stakeholders.
Results-oriented; effective ability to set and meet short-term and long-term goals.
Strong working knowledge of MS Office and Outlook.
Excellent communication, organization and decision-making skills.
Flexible in reacting to changing priorities in projects without compromising timelines and/or quality.
Please contact Larry on +353 1 – 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on Twitter, Facebook and LinkedIn