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, general 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 levels
LI-REMOTE