Everest Clinical Research · 1 week ago
Principal Data Manager I
Bridgewater, NJ
Full-time
Hybrid
Senior Level, Lead/Staff
$130K/yr - $155K/yr
10+ years expEverest Clinical Research is a full-service contract research organization providing expertise-based clinical research services to pharmaceutical, biotechnology, and medical device industries. They are seeking a Principal Clinical Data Manager to act as the primary contact for data management timelines and deliverables, perform hands-on data management tasks, and ensure quality deliverables in compliance with trial Sponsors’ requirements.
Pharmaceutical
Responsibilities
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
Qualification
Required
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
Company
Everest Clinical Research
Everest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields
501-1000 employees
H1B Sponsorship
Everest Clinical Research has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (4)
2023 (4)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$0.1MKey Investors
FedDev
2020-12-07Acquired
2019-08-18Grant· $0.1M
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