Manager, Clinical Data Management
New
E
Elan Solutions LLCClinical Research
United States, PST time zone (flexible)Full-TimeManager
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- 12+ years of hands-on data management experience
- Required Skills
- SQLGCPData management
Requirements
- 12+ years of hands-on data management experience.
- 6-7 years of managerial experience, managing a team of at least 5 people.
- 4+ years of experience in the CRO or Pharmaceutical/Biotechnology environment.
- B.S./B.A. in a science or technical discipline.
- Experience with various data collection and EDC systems.
- Knowledge of FDA, EMA, ICH guidelines, and GCPs.
- Excellent oral and written communication skills.
- Willingness to travel 2-3 times a year.
Responsibilities
- Provide data management expertise to project teams, clients, and CROs, including study startup documents, data cleaning, DCF/query tracking, database QC, and SAE/AE reconciliation.
- Oversee development of specifications for eCRFs/CRF, edit checks, electronic data handling, manual review, and User Acceptance Testing.
- Conduct cross-functional data reviews, identify issues, and track resolutions.
- Innovate and implement new technologies for process improvements.
- Ensure adherence to quality control procedures.
- Write and update SOPs and training guidelines.
- Facilitate internal study team, client, and CRO meetings.
- Review study data quality, provide metrics, and report out-of-scope activities.
- Manage timelines and resources to meet deadlines.
- Direct and manage team members, including training, resource assignment, and performance reviews.
View Full Description & ApplyYou'll be redirected to the employer's site
