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Clinical Data Management Manager – United States Remote
Lead clinical data management teams, study delivery, budgets, quality, and process improvement for Worldwide Clinical Trials. The role combines team leadership, sponsor engagement, and operational oversight within a global contract research organization.
संयुक्त राज्य
कैलिफ़ोर्निया
कनेक्टिकट$99,000 – $1,96,000 / वर्ष
रिमोटपूर्णकालिकवरिष्ठलीडआवश्यक भाषा: अंग्रेज़ीनैदानिक अनुसंधानविवरण
- Lead assigned clinical data management teams and projects, overseeing study execution and budgets
- Serve as the main contact for internal and external escalations related to assigned studies
- Represent Worldwide Clinical Trials in sponsor governance meetings
- Assign staff to projects based on their capabilities and competencies
- Provide team oversight, training, mentoring, and career development support
- Confirm appropriate project resourcing and address operational or budget risks
- Handle performance-related escalations involving team members
- Communicate upcoming staff availability to Data Management leadership to support utilization continuity
- Assist Business Development with proposals and sponsor presentation materials
- Participate in sponsor audits, regulatory inspections, and third-party meetings
- Act as a subject matter expert for assigned Data Management processes when needed
- Evaluate and improve process effectiveness and efficiency
- Deliver process training and serve as a central contact for related questions
- Lead quality issues, including root-cause analysis and CAPA activities when required
- Maintain and revise QMDs and other process guidance documents
- Coach and mentor members of the Data Management department
- Direct departmental process improvement and efficiency initiatives
- Complete additional duties as assigned
आवश्यकताएँ
- Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related field, or equivalent relevant experience
- At least nine years of clinical data management or related experience in the pharmaceutical, biotechnology, or medical device industry
- Two to four years of line management experience
- Expertise in clinical-trial data management best practices and technologies
- Advanced knowledge of clinical trial operations and protocol documents, including protocols, statistical analysis plans, CRFs, and study reports
- Strong project management capabilities, including oversight of data management teams, operations, and budgets
- Experience with recruitment, career development, and performance reviews as a line manager
- Exceptional attention to detail
- Strong written and verbal communication abilities
- Effective interpersonal and communication skills for working with cross-functional internal and external teams
- Ability to analyze issues and solve problems independently
लाभ
- Benefits package varies by location
- Transparent compensation practices with a focus on pay equity
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