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Senior Clinical Data Manager - Sponsor Dedicated, Fortrea (Poland Remote)
Lead sponsor-dedicated clinical data management for Fortrea, overseeing studies, vendors, budgets, data quality, standards, and client relationships.
विवरण
- Lead Clinical Data Management activities for assigned projects or indications
- Hold global accountability and act as the second project-level contact
- Direct studies involving healthy volunteers or patients, multiple sites, complex protocols, demanding client-management needs, or accelerated timelines
- Coordinate and prioritize workloads and deliverables
- Plan and produce Clinical Data Management deliverables at program and project levels
- Oversee vendor contracts, staffing, budgets, and vendor performance
- Communicate and negotiate with program-level stakeholders
- Act as the principal Clinical Data Management contact
- Implement consistent Clinical Data Management processes and documentation across assigned programs
- Supervise external providers and internal teams to deliver high-quality data in line with procedures and standards
- Advise on company standards, processes, systems, and expectations
- Manage risks and resolve or escalate Clinical Data Management improvement and technology issues
- Build knowledge of CDASH, SDTM, and other recognized industry standards and their effects on programming teams
- Review therapeutic-area-specific data capture and standards through lessons learned, then share findings
- Coach Clinical Data Management colleagues and stakeholders
- Direct project-level activities that support study delivery
आवश्यकताएँ
- A university or college degree in life sciences, pharmacy, or a related field is preferred, or certification in a related allied health profession from an appropriately accredited institution
- Eight years of combined early- or late-stage data management experience
- At least two years of direct sponsor-management experience
- At least two years of experience providing technical mentoring
- Demonstrated ability to manage customer negotiations
- Experience managing Statements of Work and budgets
- Extensive clinical data management experience
- Experience leading studies in a CRO or pharmaceutical environment
- Strong oral, written, and presentation communication skills
- Thorough knowledge of clinical trial processes and data management, clinical operations, biometrics, quality management, and systems applications
- Working knowledge of CRO-industry relationships and regulatory obligations with pharmaceutical and biotechnology companies
- Ability to lead by example in project strategy and in achieving departmental goals, objectives, and initiatives
- Demonstrated management and interpersonal capabilities
लाभ
- Highly competitive compensation packages
- Pension contributions
- Complimentary health insurance plans
- Allowances for remote work
- Support for work-life balance
- Flexible working hours
- Comprehensive onboarding with guidance from a personal mentor
- Permanent employment contract with Fortrea Drug Development
- Career advancement opportunities
- Mentoring, training, and individualized development planning
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