Title: Senior Clinical Data Manager
Type: Permanent Full-Time
SRG is a Global Life Sciences staffing and consulting firm is currently seeking several Senior Clinical Data Managers for permanent full-time employment opportunities across the United States (on-site, remote and hybrid potential). At SRG, we are taking STEM careers further because we are the leader in the Life Science human capital industry and are hiring for science, clinical and engineering jobs to help you develop your scientific career in the right direction. At SRG, we speak your language!
Responsibilities and Key Activities (not limited to):
- Manage all phases of data management activities and support to internal project teams, clients and Clinical Research Organization (CRO) including the following:
- Create, review and approve study startup documents, eCRF/Database specifications, Edit Check specifications, Data Management Plan (DMP), UAT Plan and related documents, CRF Completion guidelines and other documentation as required.
- Supervise data cleaning activities including processing queries, performing ongoing data review, and orchestrating scheduled cross-functional data review/reconciliation, identifying issues, data trends and tracking them through resolution.
- Responsible for all database build activities, database validation and review and execution of User Acceptance Testing
- Represent Data Management in internal study team, client and CRO meetings.
- Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to manager any requested out of scope activities.
- Assist DM oversight role/manager in monitoring timelines and managing resources to meet timelines
- Identify inconsistencies and inefficiencies in data management processes and recommend solutions.
- Direct team members in daily activities including training and supervising Clinical Data Managers I and II
KNOWLEDGE & SKILL REQUIREMENTS
- 5 - 8 years of Clinical Data Management experience; minimum 4 years in the CRO environment.
- Meet the requirements of a Clinical Data Manager II with a high degree of proficiency and autonomy.
- Ability to program in SQL or SAS desirable, but not required
- Experience with various data collection and Electronic Data Capture (EDC) systems (Medidata Rave and Medrio preferred, but not required) and related tools and processes.
- Strong working knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonisation (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
We thank all applicants in advance for their applications! Please note, only candidates who are selected to be moved forward in the recruitment process will be contacted by a member of the SRG Recruitment Team!
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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