Principal 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 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 Principal Clinical Data Manager 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.

Key Accountabilities :

Act as the primary contact person for communication and discussion of topics related to data management timelines and deliverables;

requests for out-of-scope tasks; and first line contact for technical or procedural issues.

Perform hands-on data management tasks including, but not limited to, writing database design specifications, test plans for user acceptance testing (UAT), and data transfer specifications.

When these tasks are assigned to Data Management support team members, the Principal Clinical Data Manager is responsible for review or to provide data management oversight and approvals for the task performed to ensure quality deliverable, including review of UAT plans to ensure accuracy and consistency among projects.

Facilitate and participate in UAT, as necessary.

Review data, issue queries, and resolve queries from various data sources (e.g., medical coding, medical history, adverse events, procedures and medicinal products, and external data).

Assist other Clinical Research Organizations, Sponsor, or Investigative Sites with resolving queries.

• Perform third party non-Case Report Form data management activities.
• Plan, manage, and perform data processing and data management activities for assigned projects to ensure tasks are performed in a timely manner and in compliance with trial Sponsors’ requirements.
• Accurately and efficiently validate electronically captured data. Lead efforts in writing clear queries on missing data and data points failing pre-defined range checks and / or logical checks.
• Validate and disseminate real-time study monitoring reports to Sponsor and internal team members.
• Review database edit check specifications 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.
• Perform training on the electronic data capture (EDC) system, dataflow, and quality control (QC) processes to clinical trial personnel.
• Participate in project kick off meetings, investigators meetings, and regular project management team meetings.
• Perform study-level resource planning and management, including the review of team members’ timesheet reports.
• Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
• Develop and maintain the Data Management Plan (DMP). Document deviations from the DMP.
• Assist in development and implementation of clinical data standards, training standards, project management, and data management technologies.
• Develop and maintain the 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.
• Assist in the development of project bids, billing, tracking of out-of-scope tasks, and participate in bid defense meetings.
• Perform project tracking and maintain project milestones and timelines. Report and resolve any issues with defined timelines and deliverables to the next line of management.
• Promote effective project management practices. Review and assess timesheet summary reports for assigned projects.
• Follow up on regulatory requirements, industry trends, benchmarks, and best working practices in data management by reading and participating in relevant training and / or association activities.
• Participate in and contribute to CDM departmental improvement initiatives.
• Define and monitor clinical trial data flow and QC processes in accordance with corporate Standard Operating Procedures, Good Working Practices, and departmental guidelines.
• Provide training to study site and Sponsor personnel on data entry and review (electronic data capture studies), data flow, and QC processes.
• Cooperate and assist the Quality Assurance (QA) department with QA audits on assigned databases.
• Ensure project team maintains and prepares 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 :

• M.Sc. or B.Sc. in a related field.
• Ten (10) years of related experience.
• 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 leadership ability to effectively manage clinical trial data management activities and integrate them with the entire clinical trial operation.
• Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels.
• Excellent presentation skills and the ability to build relationships with both internal and external clients.
• Demonstrated ability to effectively organize and integrate the activities of information processing.
• Must be well organized, able to work independently, and manage multiple projects / tasks appropriately.
• Demonstrated knowledge of Data Management processes and data flow with the skill to ensure quality delivery.
30+ days ago