Senior Clinical Data Manager (RWE/RWD) # 4426

Responsibilities:

• Work closely with GRAIL study team members to ensure that clinical and real-world data captured is complete, consistent, and accurate across all data sources.
• Perform study startup activities such as study protocol review, Clinical Data Management Plan (CDMP) development, and Electronic Data Capture (EDC) set-up, while collaborating with Clinical Technology staff to integrate EDC with external and real-world data sources (e.g., EHR, laboratory, registry, or other vendor-provided datasets).
• Manage study conduct activities including facilitation of study team data review, documentation of data handling decisions, issuance of data queries, and resolution of data discrepancies across traditional clinical and real-world data sources.
• Utilize programming skills to create listings and dashboards as required by study team members, including review and reconciliation of external or real-world datasets.
• Lead data locking efforts, ensuring that study team members have executed according to the CDMP and that all contributing data sources are appropriately reviewed and documented.
• Ensure that data integrity is maintained throughout the data lifecycle for sources including clinical data, external bio-specimen storage data, real-world data (RWD), and data produced by ultra-deep ctDNA sequencing laboratories.
• Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
• Create and/or review Data Transfer Plans (DTPs) with external data providers or collaborators, including vendors supplying real-world or observational data.
• Assist the Director of Clinical Data Management and other GRAIL staff with developing and implementing data standards, controlled procedural documents, and software development efforts supporting both interventional and real-world data collection models.

Required Qualifications:

• Bachelor's degree with 5+ years of industry experience in clinical data management within the pharmaceutical, biotechnology, diagnostics, or healthcare industry in an FDA-regulated environment, including experience supporting studies that incorporate real-world data (RWD) or real-world evidence (RWE) required.
• Experience working on IDE trials and device registries within the medical device and/or pharmaceutical industry.
• Prior experience leading mid to large scale clinical trials and ability to support multiple projects at a given time. 
• Understanding of Real World Data (RWD) and Real World Evidence (RWE).
• Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA).
• Strong interpersonal communication (written and verbal) and organizational skills.
• Excellent team player with demonstrated track record of success in a cross-functional team environment.
• Consistent commitment to delivering on team goals with a sense of shared urgency.
• Experience managing vendors and partnering with collaborators to deliver according to contracts and plans.
• Familiarity with various data visualization, analytics, and reporting tools (e.g. tableau).
•  Prior experience working on the sponsor side is required
• Experience working on developing/reviewing standard operating procedures for clinical data management in collaboration with cross functional teams required.

Preferred Qualifications:

• Advanced degree (with epidemiology, informatics) preferred.
• Solid understanding of programming, analytics, or related disciplines is strongly desired.
• Experience working with EDC systems, with some EDC build experience is preferred.
• Experience programming in R, SAS, Python is preferred. 
• Molecular diagnostics industry experience preferred.

Physical Demands and Work Environment:

• Hours and days may vary depending on operational needs.
• Standing or sitting for long periods of time may be necessary.
• Some lifting (up to 25 pounds) may be necessary
• Requires that a minimum of 40%, or 24 hours, of your total work week be on-site.