Manager Clinical Data Management
Round Lake, IL
Req ID 51438BR
Business Title
Manager, Clinical Data Management
Business
Medical Products
Sub-Business
Research & Development
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
Summary: The position is responsible for ensuring the on-time, compliant execution of all data management activities in support of clinical trials for two or more therapeutic areas
Essential Duties and Responsibilities:
•Working collaboratively with cross-functional teams to develop timelines and define deliverables in support of clinical trials and regulatory submissions
•Creating, reviewing, and approving data management deliverables, including: case report forms (CRFs), edit check specifications, and data management plans
•Testing databases and edit checks for accuracy and completeness
•Ensuring compliance with applicable procedures, processes and regulations in the completion of all data management activities
•Maintaining effective relationships with external service providers (e.g., application vendors, CROs)
Job Requirements
Qualifications:
•Highly proficient in the use of Oracle Clinical
•Very proficient in all data management functions, including: CRF design, edit check development, creation of Data Management Plans, SAE and lab reconciliation
•Experience as lead data manager for multiple clinical trials (Phase I - IV) in 2 or more therapeutic areas from study start-up to study close-out
•Excellent analytical, decision-making, organizational, interpersonal, communication, and project management skills
Education and/or Experience:
•Minimum: Bachelors degree; at least 4 years experience in the Pharma, Device or Biotech industry; project management experience
•Preferred: Master's degree; electronic data capture (EDC) experience; MedDRA and WHO Drug coding experience
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
