Senior Clinical Data Manager

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, built on a strong foundation as a statistical and data management center of excellence. Since then we have expanded into a full-service CRO with headquarters in Markham (Greater Toronto Area), Ontario, Canada, and additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai, China, and Taipei, Taiwan.

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

We are seeking committed, skilled, and customer‑focused individuals to join our winning team as Senior Clinical Data Managers for our Bridgewater, New Jersey, USA on‑site location, or remotely from a home‑based office anywhere in the USA in accordance with our Work from Home policy.

• Develop and maintain Data Management Project Plan; document deviations, log and report issues, and follow up on their resolutions.
• Serve as the primary contact for day‑to‑day data management activities and be ultimately responsible for all data management deliverables for assigned projects.
• Act as the primary contact for communication and discussion of topics related to data management timelines and deliverables, including requests for out‑of‑scope tasks and first‑line contact for technical or procedural issues.
• Plan and implement data management timelines and deliverables; provide database and data management activities status reports; contribute to overall project planning, progress tracking, and reporting.
• Assist with study‑level resource planning and management, including review of team members’ timesheet reports.
• Assist in performing client relationship management activities; participate in project bid defense meetings when required.
• Perform training on electronic data capture (EDC) system, dataflow and quality control processes for clinical trial personnel.
• Provide training to new data management personnel on processes and procedures; perform QC review of work performed by less experienced 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 meetings, investigator meetings, and regular project management team meetings.
• Provide support to client audits and regulatory inspections; follow up on audit findings.
• Create and maintain clinical trial Data Management Study Binders.

• Design and review case report forms (CRFs/eCRFs); develop and review case report form completion instructions; generate and review annotated CRFs.
• 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 and 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 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; assist investigative site personnel with resolving queries.
• Perform serious adverse event reconciliation.
• Assist in resolving medical coding discrepancies from coding of medical history, adverse events, procedures, and medicinal products.
• Cooperate with the Quality Assurance Department for 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…