Clinical Data Manager

Join to apply for the Clinical Data Manager role at Everest Clinical Research. Everest Clinical Research (“Everest”) is a full‑service contract research organization (CRO) that provides a broad range of expertise‑based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. With headquarters in Markham, Ontario, and additional sites in New Jersey, Shanghai, and Taipei, Everest has been an independent CRO since 2004 and recently acquired August Research, expanding its European footprint. Everest is known in the industry for its high‑quality deliverables, superior customer service, and flexibility in meeting client needs. We continue to experience exceptional growth and great success.

We are seeking a committed, skilled, and customer‑focused Clinical Data Manager to work remotely from a home‑based office anywhere in the UK, in accordance with our Work‑from‑Home policy.

Key Accountabilities

• Plan, manage, control, and perform data processing and management activities for assigned projects in a timely and accurate manner and in compliance with trial Sponsors’ requirements.
• Lead assigned data processing and management projects by applying project management skills, data processing, and management techniques.
• Manage timelines and coordinate activities for assigned projects.
• Specify database validation checks for assigned studies.
• Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules.
• Define and monitor clinical trial dataflow and quality control (QC) processes in accordance to corporate Standard Operating Procedures (SOPs), Good Working Practices, and unit guidelines.
• Perform clinical trial site monitors’ training on dataflow and QC processes.
• Design and review patient Case Report Forms (CRFs) and database schema.
• Test data capture/entry screens.
• Accurately and efficiently validate electronically captured data.
• Write clear queries on missing data and data points failing pre‑defined range checks and/or logical checks.
• Lead efforts in building a standard query library for common database modules, as well as for therapeutic/drug area specific modules.
• Perform QC procedures on assigned database during the trial and additional database closure checks at the end of the study.
• Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific handling, and management of trial data.
• Validate and distribute study progress status reports to internal and external study team members.
• Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment procedures, and medications.
• Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.
• Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies.

Qualifications and Experience

• A Bachelors’ degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields with at least 2 years experience in clinical trial data capture and management, or a Master’s or Ph.D. degree in these fields with at least 1 year relevant experience.
• 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.
• Strong leadership in clinical data management activities and a desire to excel in leading data management projects.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com. We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.