Senior Manager, Clinical Data Management
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $151,000 - $188,700 per year
Job Level
Tech Stack
About the role
- Provide timely and professional ongoing management of project and clinical trial data.
- Work closely with outsourced clinical data management (CDM) activities with various Contract Research Organizations (CROs).
- Ensure study team expectations are clearly communicated to the CRO.
- Provide comprehensive data management expertise to deliver efficient data management products.
- Serve as the Lead Data Manager on studies.
- Understand and comply with core standard operating procedures (SOPs).
- Review and approve various CDM documents.
- Communicate ideas for process improvement.
- Provide project updates to management weekly and monthly.
Requirements
- Minimum 8 – 12 years (without Master’s) or 6 – 8 years (with Master’s) of relevant experience in biotech or pharmaceutical industry.
- Thorough knowledge of the data management process.
- Thorough understanding of clinical trial methodology, GCP and medical terminology.
- Electronic Data Capture (EDC) experience, preferably Rave EDC
- Requires a high level of initiative and independence.
- Excellent written and oral communication skills required.
Benefits
- merit-based salary increases
- overtime
- short incentive plan participation
- eligibility for 401(k) plan
- medical, dental, vision, life and disability insurances
- up to 120 hours of vacation per year
- 11 paid holidays
- additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
- access to service recognition program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data managementclinical trial methodologyGCPmedical terminologyElectronic Data CaptureRave EDC
Soft Skills
initiativeindependencewritten communicationoral communication