Title: Senior Clinical Data Manager
Company: CRO Company
Location: Little Falls, NJ | Remote
Type: Permanent Role
Notes: No Corp to Corp
- Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
- Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
- Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.
- Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.
- Assist with study-level resource planning and management, including the review of team members' timesheet reports.
- Assist in performing client relationship management activities. Participate in project bid defense meeting when required.
- Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
- Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.
- Assist in generation of project Work Orders and Amendments.
- Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors).
- Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
- Provide support to client audits and regulatory inspections. Follow up on audit findings.
- Create and maintain clinical trial Data Management Study Binders.
Perform Hands-on Data Management Activities
- Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
- Design and review Clinical Trial Source Document templates and completion instructions when required.
- Develop and maintain data validation specifications.
- Develop and maintain Data Management Plan (DMP). Document deviations from the DMP.
- Participate in the database design process. Participate in EDC User Acceptance Testing (UAT).
- Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
- Develop and maintain 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.
- Perform Third Party non-CRF data management activities.
- Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries.
- Perform Serious Adverse Event reconciliation.
- Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
- Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases.
- Perform database soft-lock and hard lock activities.
- Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving such documentation.
- BS or MS in Health Science, Pharmaceutical Sciences and/or related field
- At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 year of experience as a Clinical Data Manager II
- 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.
- Have manage clinical trial data management activities, applying data management concepts, clinical trial data processing techniques, and integrating them with the entire clinical trial operations.
- Experience with EDC systems (Medidata Rave and/or Inform)
- Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is required.
- Excellent oral and written communication skills
- Good organizational and logical skills
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