Principal Data Manager I

Everest Clinical Research•Bridgewater Township, NJ

23d•$130,000 - $165,000

About The Position

Everest Clinical Research is seeking a Principal Clinical Data Manager for its Bridgewater, New Jersey, on-site location or 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 studies, ensuring timely, high-quality deliverables that comply with sponsor requirements, corporate procedures, and applicable clinical trial standards. The Principal Clinical Data Manager serves as a primary contact for data management timelines, deliverables, out-of-scope requests, and technical or procedural issues. The position combines hands-on work—such as database design specifications, UAT plans, data transfer specifications, data review, query management, and third-party non-CRF data management—with oversight and approval of work performed by support team members. It also involves study planning, resourcing, milestone tracking, sponsor and site communication, training, quality review planning, and coordination with programmers, QA, and project teams. The successful candidate has a related bachelor’s or master’s degree and ten years of related experience, with in-depth clinical trial data management knowledge, demonstrated leadership, strong communication and presentation skills, and the ability to organize work independently across multiple projects. The company offers medical, dental, and vision coverage; life and AD&D insurance; short- and long-term disability; tuition and fitness reimbursement; an employee assistance program; a 401(k) retirement/pension plan; paid time off and sick leave; and the opportunity to earn a performance-based bonus. The estimated salary range is $130,000–$165,000.

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.
Demonstrated leadership ability to manage clinical trial data management activities and integrate them with overall clinical trial operations.
Effective oral and written communication with personnel at professional and administrative levels.
Excellent presentation skills and ability to build relationships with internal and external clients.
Ability to effectively organize and integrate information-processing activities.
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

Serve as the primary contact for data management timelines and deliverables, out-of-scope requests, and first-line technical or procedural issues.
Perform hands-on data management work, including writing database design specifications, UAT test plans, and data transfer specifications; review, oversee, and approve assigned support-team work and facilitate or participate in UAT as needed.
Review data, issue and resolve queries across data sources, and assist sponsors, sites, and other CROs with query resolution.
Perform third-party non-CRF 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 clear queries for missing data or data failing range or logical checks.
Validate and distribute real-time study monitoring reports to sponsors and internal team members.
Review database edit-check specifications and lead development and maintenance of standard validation checks for common and therapeutic- or drug-area-specific modules.
Train clinical trial personnel on the EDC system, data flow, and QC processes.
Participate in project kickoff meetings, investigator meetings, and regular project management meetings.
Plan and manage study-level resources, including reviewing team members’ timesheet reports.
Manage post-go-live database modifications arising from protocol amendments or study needs.
Develop and maintain the Data Management Plan and document deviations from it.
Assist with developing and implementing clinical data standards, training standards, project management practices, and data management technologies.
Develop and maintain the Data Quality Review Plan and coordinate with programmers on programming and validation of its listings and summary tables.
Assist with project bids, billing, and tracking out-of-scope tasks, and participate in bid defense meetings.
Track projects and maintain milestones and timelines; report and resolve issues affecting timelines or deliverables with the next line of management.
Promote effective project management practices and review and assess project timesheet summary reports.
Keep current with regulatory requirements, industry trends, benchmarks, and data management practices through reading, training, and 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 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 QA in audits of assigned databases.
Ensure project teams prepare and maintain final archival data management documentation for assigned trials, and assist the corporate archivist with assembling and archiving documentation.