Senior Clinical Data Manager/Principal Clinical Data Manager
hace 6 días
The Senior Clinical Data Manager/Principal Clinical Data Manager will oversee all aspects of the clinical trial data management process from start-up to post-database lock for assigned projects. This role follows Standard Operating Procedures / Work Instructions (SOPs / WIs), regulatory directives, study-specific plans, and guidelines. The position will also oversee and/or perform database development and testing.
Key Responsibilities- Ensure timely and quality delivery of clinical data management services
- Develop and implement data management plans, including data entry guidelines, training, and quality control
- Oversee project data entry process, including development of data entry guidelines, training, data entry quality, and resourcing
- Conduct quality control of data entry and ensure the overall quality of the clinical database
- Develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders
- Assist in building clinical databases, conducting database build UAT, and maintaining quality-controlled database build documentation
- Specify requirements for all edit check types (e.g., electronic, manual data review, edit checks, etc.)
- Maintain data management documentation, including creating, revising, and appropriate versioning
- Train clinical research personnel on study-specific CRF, EDC, and other project-related items as needed
- Review and query clinical trial data according to the Data Management Plan
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
- Coordinate SAE/AE reconciliation, and liaise with third-party vendors in a project-manager capacity in support of timelines and data-related deliverables
- May assist with SAS programming and quality control of SAS programs used in the Data Management department
- Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
- May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if required by the project
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
- Bachelors and/or a combination of related experience
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device, and/or biologic development and effective data management practices
- Strong representational skills, ability to communicate effectively orally and in writing
- Strong leadership and interpersonal skills
Preferred qualifications include experience in a clinical, scientific, or healthcare discipline, dictionary medical coding (MedDRA and WHODrug), understanding of CDISC standards (CDASH, SDTM, ADaM, etc.), and oncology and/or Orphan Drug therapeutic experience.
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