Principal Clinical Data Associate
Advanced Clinical · Ahmedabad · onsite · Posted 51d ago
Undisclosed7–12 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
The Principal Clinical Data Associate ( CDA ) will have experience in all required areas of a Senior Clinical Data Associate. The Principal CDA is responsible for all data review associated activities for a clinical study. The Principal CDA may provide oversight to other CDAs and may assist the Lead with additional data management activities.
Responsibilities:
- Exceed expectations and responsibilities of a Senior Clinical Data Associate
- May serve as the Lead Data Manager
- May assist in the creation of the DMP, eCCGs, Edit Check Specifications, data review listing specifications and other start-up documents
- Perform user acceptance testing
- May assist with EDC module integrations/setup (ePRO, Randomization, Dispensing, etc.)
- Review eCRFs in the database to ensure data consistency and completeness
- Perform manual data review and data listing review as defined on assigned studies
- Review and respond to answered queries by the site and issue re-queries as needed
- Generate manual queries
- Communicate potential data issues to the appropriate data management personnel
- Perform reconciliation of SAEs and external vendor data as required for assigned studies
- Identify data trends and report inconsistencies to applicable data management personnel; collaborate to develop and implement actions to address
- Perform user account management
- Collect and report on study metrics
- Perform data entry or quality control review of local lab data
- Perform Quality Control review
- Perform EDC archival tasks
- Serve as subject matter expert
- Provide training and mentoring for other Clinical Data Associates
- Standard Operating Procedures (SOPs)
- Strong understanding of departmental and company procedures; ability to guide others on procedures
- Participate in the development and revision of department SOPs
- Business Development
- May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
- Additional Responsibilities
- Perform other duties as requested by management
- Participate in data management candidate interviews
Qualifications:
- Minimum of 7 years direct data management experience in pharmaceutical development or CRO environment
- Bachelor s Degree preferred. Work experience may be substituted for degree
- Working knowledge of CDASH standards
- Excellent oral and written communication skills, organizational skills, and attention to detail are required
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
clinical dataEDCManager Quality ControlCROUser acceptance testingData ManagementData EntryreconciliationPharmaaccount management