Senior Manager, Clinical Data Management
Crinetics Pharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $138,000 - $172,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Manages the assigned study/studies and makes expert recommendations and/or decisions that assure timelines, deliverables and data quality.
- Collaborates cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process.
- Resolves and/or escalates issues encountered at the study level and ensures the performance of the data management function.
- Provides effective CRO/vendor oversight to ensure requirements are met and the project plans are executed to meet the development needs.
- Leverages data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders.
- Contributes to team building and best practice to achieve the defined data quality with cost efficiency.
- Participates in regulatory audit and/or company initiatives.
Requirements
- MS/BS in life sciences or related field
- 7 + years of direct data management experience and at least 3 years of CRO oversight experiences
- In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry
- Strong project management skills and experiences working with CROs/vendors
- Demonstrated organizational and interpersonal skills
- Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting
- Highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance
- Knowledge of GCP, ICH and other regional regulations and compliance
- Experiences with clinical data lifecycle from database set-up and maintenance to database lock and archiving
- Working knowledge of current technologies in clinical trial data collection systems.
Benefits
- Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data managementclinical data managementproject managementCDISC standardsSDTM requirementsCFR-Part 11 ComplianceGCPICHclinical data lifecycledatabase set-up
Soft skills
organizational skillsinterpersonal skillscommunication skillsdetail orientedteam buildingcollaborationproblem-solvingdecision-makingcross-functional teamworkcost efficiency