About Us
About the Role
You will oversee all clinical data management activities and deliverables from study start-up through database lock and closeout across multiple clinical trials. Working independently with cross-functional teams and external partners, you will ensure the delivery of complete, accurate, high-quality, and regulatory-compliant data to support study reporting, publications, and regulatory submissions. This role requires a balance of strong operational execution and innovative thinking to advance data quality, integration, and analysis in support of clinical development goals.
We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Key Responsibilities
- Responsible for relationships with Data Management partners (eg, CROs and vendors)
- Oversight of outsourced study-related DM activities including CRF design, data collection, edit checks and listings reviews, data reconciliation (SAEs, labs, other external data), medical coding, UAT testing, database lock and archival of DM documents.
- Accountable for ensuring data quality and timeliness of DM deliverables are met and align with company goals
- Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the Trial Master File
- Represent DM during Investigator Meetings, CRA training, on-site visits, company or department meeting
Experience
- Bachelors degree in life sciences required
- Minimum of 5 years of clinical data management experience in Sponsor and/or CRO setting
- Strong understanding of DM related systems, technologies and standards including data analytics platforms
- Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management
- Self-motivated and able to work autonomously as well as take direction and work within a high-functioning and collaborative team environment
- Detail-oriented with strong verbal and written communication skills
- Ability to build relationships internally and with external partners
- Highest levels of professionalism, confidence, personal values and ethical standards
United States
AU, CA + 4 more
CA, FR + 5 more