Senior Clinical Data Manager I
Join to apply for the Senior Clinical Data Manager I role at Everest Clinical Research.
Everest Clinical Research (“Everest”) is a full‑service contract research organization (CRO) providing a broad range of expertise‑based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. Everest has been an independent CRO since 2004 with a strong foundation in statistics and data management. The company’s headquarters are in Markham (Greater Toronto Area), Ontario, Canada, with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China, and Taipei, Taiwan. Everest recently acquired August Research, a European CRO, adding a European footprint and expanding its full-service capabilities across 14 countries in Western and Eastern Europe. Everest is known in the industry for high‑quality deliverables, superior customer service, and flexibility. The organization enjoys exceptional growth and success.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer‑focused individuals to join our winning team as Senior Clinical Data Manager remotely from a home‑based office anywhere in the UK in accordance with our Work from Home policy.
Key Accountabilities
- Develop and maintain the Data Management Project Plan. Document deviations, log and report issues, and follow up on their resolutions.
- Act as the primary contact for daily data management activities and ultimately responsible for all data management deliverables for assigned projects.
- Lead communication and discussion related to data management timelines and deliverables, request out‑of‑scope tasks, and serve as the first line contact for technical or procedural issues.
- Plan and implement data management timelines and deliverables. Provide database and data‑management activity status reports and contribute to overall project planning, progress tracking, and reporting.
- Assist with study‑level resource planning and management, including review of team members’ timesheet reports.
- Support client relationship management activities and participate in project bid defense meetings when required.
- Conduct training on the electronic data capture (EDC) system, dataflow, and quality control processes for clinical trial personnel.
- Provide training to new data management personnel and perform QC review of work done by less experienced personnel.
- Assist in generating project Work Orders and Amendments.
- Manage dataflow from and performance of third‑party vendors (Non‑CRF data vendors).
- Participate in project kick‑off meetings, investigator meetings, and regular project management team meetings.
- Provide support for client audits and regulatory inspections and follow up on audit findings.
- Create and maintain clinical trial Data Management Study Binders.
Hands‑On Data Management Activities
- Design and review case report forms (CRFs/eCRFs), develop and review CRF completion instructions, and generate annotated CRFs.
- Design and review Clinical Trial Source Document templates and completion instructions when required.
- Develop and maintain data validation specifications.
- Develop and maintain the Data Management Plan (DMP) and document deviations from it.
- Participate in the database design process and in EDC User Acceptance Testing (UAT).
- Manage the process of database modifications (after go‑live) due to protocol amendments or study needs.
- Develop and maintain the Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of listings and summary tables as specified in the DQRP.
- Perform third‑party non‑CRF data management activities.
- Review data, issue and resolve queries, and assist investigative site personnel with resolving queries.
- Perform Serious Adverse Event reconciliation.
- Assist in resolving medical coding discrepancies arising 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.
- Perform database soft‑lock and hard‑lock activities.
- Maintain and prepare final archival of data management documentation relevant to assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.
Qualifications and Experience
- A bachelor’s or master’s degree in health, pharmaceutical, biological, or chemistry sciences.
- At least five years of experience in pharmaceutical clinical trial data management, or at least two years as a Clinical Data Manager II, with demonstrated knowledge, experience, and ability to meet high‑quality standards and high levels of customer satisfaction.
- Demonstrated in‑depth understanding of clinical trial data management concepts, processes, and procedures, as well as relevant issues related to or impacting clinical data management and pharmaceutical clinical trial regulations, industry guidance, conventions and standards.
- Demonstrated 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.
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