Senior Clinical Data Manager I

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. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located 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 also recently completed the acquisition of August Research. August Research is a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients. The Company has worked on over 120 projects for Phase I-IV clinical trials across multiple therapeutic areas including cardiovascular, infectious disease, oncology and rare disease. The acquisition of August Research establishes a European footprint for Everest to provide full-service offerings to its pharmaceutical, biotechnology and medical devices clients, and other operational capabilities through the Company’s substantive experience and infrastructure across 14 countries in Western and Eastern Europe.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

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 the UK in accordance with our Work from Home policy.

Key Accountabilities:

Lead Data Management Activities, Perform Training and Client Relationship Management

• Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
• Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
• Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.
• Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.
• Assist with study-level resource planning and management, including the review of team members’ timesheet reports.
• Assist in performing client relationship management activities. Participate in project bid defense meeting when required.
• Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
• Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.
• Assist in generation of project Work Orders and Amendments.
• Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors).
• Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
• Provide support to client audits and regulatory inspections. Follow up on audit findings.
• Create and maintain clinical trial Data Management Study Binders.

Perform Hands-on Data Management Activities

• Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
• Design and review Clinical Trial Source Document templates and completion instructions when required.
• Develop and maintain data validation specifications.
• Develop and maintain Data Management Plan (DMP). Document deviations from the DMP.
• Participate in the database design process. Participate 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 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.
• Perform Third Party non-CRF data management activities.
• 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.
• Perform database soft-lock and hard lock activities.
• Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.

Qualifications and Experience:

• A Bachelors’ 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 year 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.