Senior Clinical Data Manager

1 week ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Senior Clinical Data Manager

Everest Clinical Research Services Inc is seeking a highly skilled Senior Clinical Data Manager to join our team in Bridgewater, New Jersey, USA or remotely from a home-based office anywhere in the USA. As a Senior Clinical Data Manager, you will be responsible for leading data management activities, performing training, and client relationship management.

Key Responsibilities:
  • Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
  • Lead data management activities, including planning and implementing data management timelines and deliverables.
  • Provide training on electronic data capture (EDC) system, dataflow, and quality control processes to clinical trial personnel.
  • Assist in performing client relationship management activities, including participating in project bid defense meetings.
  • Perform hands-on data management activities, including designing and reviewing case report forms (CRFs/eCRFs), developing and reviewing Case Report Form Completion Instructions, and generating and reviewing annotated Case Report Forms.
  • Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
  • Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.
  • Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries.
  • Perform Serious Adverse Event reconciliation.
  • Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures, and medicinal products.
  • Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases.
  • Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials.
Qualifications and Experience:
  • A Bachelor's or Master's degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
  • At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 years of experience as a Clinical Data Manager II, with demonstrated knowledge, experience, and ability to perform to meet high quality standards and high level of customer satisfaction.
  • Demonstrated an in-depth understanding of clinical trial data management concepts, processes, and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.
  • Demonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects.

We are looking for a highly skilled and experienced Senior Clinical Data Manager to join our team. If you have a strong background in clinical trial data management and a passion for leading data management projects, we encourage you to apply for this exciting opportunity.

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