Principal Data Manager I

Everest Clinical Research - Bridgewater Township, NJ

Full-time - Senior

Remote - Bridgewater Township, NJ

Professional, Scientific, and Technical Services

About the position

The Principal Clinical Data Manager at Everest Clinical Research is responsible for overseeing data management activities for clinical trials, ensuring high-quality deliverables and compliance with sponsor requirements. This role involves direct communication with stakeholders, hands-on data management tasks, and leadership in developing data management plans and quality review processes. The position can be performed on-site in Bridgewater, NJ, or remotely from anywhere in the USA, aligning with the company's work-from-home policy.

Responsibilities

• Act as the primary contact for data management timelines and deliverables.
• Perform hands-on data management tasks including writing database design specifications and test plans for user acceptance testing (UAT).
• Review and provide oversight for data management tasks performed by support team members.
• Facilitate and participate in UAT as necessary.
• Review data, issue queries, and resolve queries from various data sources.
• Assist other organizations and sites with resolving queries.
• Plan, manage, and perform data processing and management activities for assigned projects.
• Validate electronically captured data accurately and efficiently.
• Lead efforts in writing queries on missing data and data points failing checks.
• Validate and disseminate real-time study monitoring reports to sponsors and internal teams.
• Review database edit check specifications for assigned studies.
• Develop and maintain standard database validation checks.
• Perform training on the electronic data capture (EDC) system and quality control processes.
• Participate in project kick-off and management team meetings.
• Manage study-level resource planning and team members' timesheet reports.
• Manage database modifications due to protocol amendments or study needs.
• Develop and maintain the Data Management Plan (DMP) and document deviations.
• Assist in developing clinical data standards and training standards.
• Develop and maintain the Data Quality Review Plan (DQRP).
• Coordinate with programmers for programming and validation of listings and summary tables.
• Assist in project bids, billing, and participate in bid defense meetings.
• Perform project tracking and maintain project milestones and timelines.
• Report and resolve issues with defined timelines and deliverables.
• Promote effective project management practices.
• Review and assess timesheet summary reports for assigned projects.
• Follow up on regulatory requirements and industry trends in data management.
• Participate in departmental improvement initiatives.
• Define and monitor clinical trial data flow and QC processes.
• Provide training to study site and sponsor personnel on data entry and review processes.
• Assist the Quality Assurance department with audits on assigned databases.
• Ensure final archival of data management documentation for clinical trials.

Requirements

• M.Sc. or B.Sc. in a related field.
• Ten (10) years of related experience in clinical trial data management.
• In-depth understanding of clinical trial data management concepts and regulations.
• Demonstrated leadership ability in managing clinical trial data management activities.
• Effective communication skills, both oral and written, with all professional levels.
• Excellent presentation skills and relationship-building abilities.
• Ability to organize and integrate information processing activities.
• Well organized, able to work independently, and manage multiple projects.

Nice-to-haves

• Experience with electronic data capture (EDC) systems.
• Familiarity with regulatory requirements and industry standards in clinical trials.

Benefits

• Work from home options available.