Clinical Study Planning Senior Associate Manager
hace 4 semanas
External Job Description**Responsibilities**:- Lead the development of realistic study timelines, from design through final study reporting on priority programs- Maintaining accuracy of clinical study timeline information in Company data control systems (e.g., Planisware (PPM)- Tracking, documenting, and ensuring key stakeholder involvement and timely delivery of clinical study deliverables- Leading special projects as assigned- Represent Clinical Study Planning group in applicable forums and lead functional specific communications- Closely support Sr. Manager with Program oversight and stakeholder management, as required by the assigned program/s- Oversight of Clinical Study Planning staff, as required by the Sr. Manager- Develop and monitor clinical trial timelines: Ensure high-quality, realistic, cross-functional, global timelines within specified deadlines.- Conduct routine integrity checks: Regularly resolve data issues for assigned study timelines.- Manage, communicate & implement changes- Align funding and investment: Support operational planning by ensuring alignment of funding for clinical studies.- Collaborate and improve: Maintain strong relationships with study teams, identify bottlenecks, and contribute to continuous improvement in project management.**Qualifications**:- Master’s degree & 3 years of directly related experience or Bachelor’s degree & 5 years of directly related experience**Preferred Qualifications**:- BA/BS/BSc in the sciences or RN- 5 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company)- Minimum 3 years’ experience in Clinical Study Planning Manager role- PMP Certification- Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory- Project management tools and processes (e.g., MS Project, PPM, PowerPoint, Excel)- Strong communication skills to all levelsLI-REMOTE
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