Senior Clinical Data Manager at SynteractHCR
Senior Clinical Data Manager – Anywhere, US
Office-based in Morrisville, NC or Carlsbad, CA; Remote-based anywhere in the US
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
The Senior Clinical Data Manager is responsible for managing the clinical trial data for multiple assigned projects; acts as liaison between Company personnel and Sponsor personnel to implement and maintain clinical databases. S/he presents project-related or software-related training; coordinates activities such as medical coding, electronic data transfer, and all other aspects of data clean-up. May delegate tasks/responsibilities to multiple team members in multiple projects. Provides project oversight of daily, weekly and monthly data management tasks and Sponsor deliverables to ensure assigned projects and deliverables are on track. Additionally, s/he will serve as a technical resource to colleagues; troubleshoot technical problems; manage more complex projects.
Specific tasks would include:
- Designs, or directs the design of, a Case Report Form (CRF) for data collection.
- Coordinates the printing of CRFs, if applicable for the project.
- Coordinates CRF/Data Clarification Form (DCF) tracking, if applicable for the project.
- Develops a Data Management Plan (DMP), outlining all data management responsibilities.
- Designs, or directs the design of, an efficient logical database using the Company’s standards or the Sponsor’s specifications, which can be exported efficiently into SAS.
- Defines, validates, and documents logical edit checks for data quality control. May program database edit checks.
- Responsible for conducting and documenting project-specific training for all team members prior to project start and throughout the course of the project, as needed.
- Responsible for training end users on the applicable Clinical Data Management System, maintaining current system access and ensuring all training records are up to date.
- Responds to inquiries and provides guidance to study team to ensure accuracy of data. Able to assess skill set of team members to provide individual training and appropriately QC the work performed on an ongoing basis.
- Ensures completion of a comprehensive data review.
- Verifies, or supervises verification of, data entry, processes edit checks, query resolutions and data clarifications.
- Communicates with the Sponsor as needed regarding data/database issues. Responds to any requests or needs of the Sponsor during the course of the project.
- Understands the sequence of running SAS programs to ensure up-to-date data and to troubleshoot problems. May use SAS to develop, program and maintain any output needed within the Data Management group. Able to use SAS to review clinical datasets.
- Produces reports, listings and other output as required during the course of the project.
- Exports data from the clinical database to update the SAS database.
- Creates, or directs the creation of, subject profiles to verify the data entry of paper CRFs.
- Ensures medical coding is performed in a timely manner, as directed by the DMP.
- May perform coding of medical terms/medications.
- Receives electronic data and prepares it for use by Programming/Biostatistics. Performs reconciliation of the external data against the CRF. Interacts with vendors to resolve discrepancies.
- Ensures that all project documentation is complete, accurate and reviewed by the appropriate personnel on an ongoing basis.
- Conducts and documents the database closeout, reviews subject profile findings and provides relevant documentation to the Sponsor and the Company’s appropriate senior management members.
- Archives project documents.
- Able to accept responsibility for projects transitioned to the Company mid-project, clean up the database, the data, and the documentation.
- Assists in writing/reviewing/updating Data Management related Standard Operating Procedures (SOPs).
- May prepare and present data management topics to the department.
- May present software demonstrations and/or project-specific CRF instructions at Sponsor meetings or bid defenses.
- Provides operational and technical guidance and direction to colleagues.
- Mentors junior level DM staff
- Participates in leadership activities outside of day to day project assignments, for example: corporate or department level initiatives, provide department level training, acting as assign topic/system SME, etc.
- Bachelor’s degree in a related field of study
- 5+ years leading studies or equivalent combination of education and experience
- Experience and knowledge of Rave strongly preferred
- Experience working within a CRO environment
- Completion of a Clinical Trials certification program is an asset
- Knowledge of ICH/GCP standards, 21 CFR Part 11
- Strong attention to detail required
- Ability to effectively prioritize tasks and assignments to meet deadlines
- Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required
- Effective verbal and writing skills; English + local language, if relevant
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