Clinical Data Manager
4 weeks ago
Everest Clinical Research Services Inc is seeking a highly skilled and experienced Principal Clinical Data Manager to join our team. As a key member of our data management team, you will be responsible for ensuring the quality and integrity of clinical trial data.
Key Responsibilities:- Act as the primary contact person for communication and discussion of topics related to data management timelines and deliverables.
- Perform hands-on data management tasks, including writing database design specifications, test plans for user acceptance testing (UAT), and data transfer specifications.
- Review data, issue queries, and resolve queries from various data sources.
- Plan, manage, and perform data processing and data management activities for assigned projects.
- Validate electronically captured data and 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 and 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.
- Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
- Develop and maintain the Data Management Plan (DMP) and 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) and 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 and 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.
- 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.
Everest Clinical Research Services Inc is an equal opportunities employer and welcomes applications from all qualified candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Please submit your application, including your resume and cover letter, to [insert contact information].
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