Job Description
Position Title:
Senior Clinical Data Manager, Clinical Data Management
Department:
Clinical Data Sciences
Reports To:
Senior Director, Clinical Data Sciences
Internal Organizational Relationships:
Daily: Supervisor, Clinical Data Sciences department and colleagues in current study teams/vendors
Weekly: Project Management, Clinical Research, Clinical Operations, and Clinical Pharmacology departments
As needed: Regulatory Affairs department
Once every few months: JT Clinical Data Management (CDM) team
External Relationships:
Daily or weekly (frequency varies depending on the stage of the study): CRO, laboratory, and EDC vendors
Position Summary:
Principal Duties and Responsibilities:
Priority
Time
Allocated
High
5%
High
10%
High
15%
High
5%
High
10%
High
30%
High
15%
Medium
5%
Medium
5%
Minimum Experience Requirements:
Minimum of 8 years of experience in CDM in the pharmaceutical industry, including at least one year of experience managing outsourced services
Knowledge, Skills and Abilities:
Technical:
Must be adept at using Word, Excel, PowerPoint, SAS Enterprise Guide (for clinical data review), and Rave EDC system; must have strong biomedical background and clinical knowledge, thorough knowledge of clinical data management from study start up to database lock, and understanding of database structure and CDISC principals
Programming experiences in SAS and data visualization and review tools (such as Spotfire or JReview) are plus
Non-technical:
Must have strong written and oral communication skills, and creative and logical approach to problem solving; must be a team player
Minimum Education Requirements:
Bachelor’s degree in a life science
Working Conditions:
Physical Demands:
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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