Clinical Study Planning Senior Associate Manager - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 levels
• Strong computer literacy, including word processing, presentation, and spreadsheet applications  

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EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.