Principal Data Manager I

Everest Clinical Research•Bridgewater, NJ

22d

About The Position

Everest Clinical Research is seeking a Principal Clinical Data Manager for its Bridgewater, New Jersey on-site location or remotely from a home-based office anywhere in the USA, in accordance with its Work from Home policy. The role leads and performs clinical data management activities for assigned projects, ensuring timely, high-quality deliverables and compliance with sponsor requirements, corporate procedures, and applicable industry standards. It serves as a primary contact for data management timelines, deliverables, out-of-scope requests, and first-line technical or procedural issues. The position combines hands-on data management with oversight, project planning, quality review, team coordination, training, and client communication. Responsibilities include developing and maintaining the Data Management Plan and Data Quality Review Plan, supporting database design and validation, reviewing and resolving data queries, managing database changes, monitoring project milestones and resources, coordinating with programmers, supporting bids and billing, and contributing to departmental improvements. The role also supports quality audits and ensures clinical trial data management records are prepared for final archival.

Requirements

M.Sc. or B.Sc. in a related field.
Ten years of related experience.
In-depth understanding of clinical trial data management concepts, processes, procedures, relevant issues, pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.
Leadership ability to manage clinical trial data management activities effectively and integrate them with overall clinical trial operations.
Effective oral and written communication with personnel at all professional and administrative levels.
Excellent presentation skills and ability to build relationships with internal and external clients.
Ability to organize and integrate information-processing activities effectively.
Well organized, able to work independently, and able to manage multiple projects and tasks appropriately.
Knowledge of data management processes and data flow, with the ability to ensure quality delivery.

Responsibilities

Act as the primary contact for communication and discussion of data management timelines and deliverables, out-of-scope task requests, and first-line technical or procedural issues.
Perform hands-on data management tasks, including writing database design specifications, user acceptance testing (UAT) plans, and data transfer specifications.
Review or provide oversight and approvals for tasks performed by data management support team members, including reviewing UAT plans for accuracy and consistency.
Facilitate and participate in UAT as necessary.
Review data, issue queries, and resolve queries from sources such as medical coding, medical history, adverse events, procedures and medicinal products, and external data.
Assist CROs, sponsors, and investigative sites with query resolution.
Perform third-party non-Case Report Form data management activities.
Plan, manage, and perform data processing and data management activities for assigned projects in a timely manner and in accordance with sponsor requirements.
Validate electronically captured data and lead the creation of queries for missing data and data points failing range or logical checks.
Validate and disseminate real-time study monitoring reports to sponsors and internal team members.
Review database edit check specifications for assigned studies.
Lead development and maintenance of standard database validation checks for common and therapeutic- or drug-area-specific modules.
Train clinical trial personnel on the EDC system, data flow, and quality control processes.
Participate in project kick-off meetings, investigator meetings, and regular project management team meetings.
Perform study-level resource planning and management, including review of team members’ timesheet reports.
Manage post-go-live database modifications resulting from protocol amendments or study needs.
Develop and maintain the Data Management Plan (DMP), and document deviations from it.
Assist with developing and implementing 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 programming and validation of listings and summary tables specified in the DQRP.
Assist with project bids, billing, tracking out-of-scope tasks, and bid defense meetings.
Track projects and maintain project milestones and timelines; report and resolve issues with timelines and deliverables with the next line of management.
Promote effective project management practices and review timesheet summary reports for assigned projects.
Keep current with regulatory requirements, industry trends, benchmarks, and data management practices through relevant training and association activities.
Participate in and contribute to Clinical Data Management departmental improvement initiatives.
Define and monitor clinical trial data flow and QC processes in accordance with corporate SOPs, Good Working Practices, and departmental guidelines.
Train study site and sponsor personnel on data entry and review for EDC studies, data flow, and QC processes.
Cooperate with and assist the Quality Assurance department with audits of assigned databases.
Ensure the project team prepares final archival documentation for assigned clinical trials and assist the corporate archivist with assembling and archiving it.