Senior Project Manager, Clinical and Regulatory Affairs
Summary of Major Responsibilities
The Senior Project Manager, Clinical and Regulatory, is responsible for planning, leading and coordinating activities to support the operational success of clinical and regulatory projects. The position will work cross-functionally to develop project plans and timelines to ensure overall goals are accomplished in alignment with business objectives.
Essential Duties and Responsibilities
- Leads cross-functional project teams to accomplish project goals.
- Consults with project sponsors and reviews project proposals to determine goals, time frame, funding, allotment of resources and procedures for accomplishing projects.
- Identify and schedule project deliverables, milestones and required tasks.
- Troubleshoots problems associated with coordination, development, or design of projects.
- Escalates issues when critical risks arise and maintains pulse with project activities to ensure progress.
- Directly or indirectly leads cross-functional teams to execute on project tasks to include effective creation and management of timelines, budgets, resources, risks and project objectives.
- Collaborates with other project and program managers to manage project interdependencies.
- Acts as a problem solver to drive decisions.
- Prepares status reports and modifies schedules and plans as required.
- Follows established project management practices, including management of scope, requirements, issues, and risks.
- Creates MS Project schedules, and utilizes the schedule to communicate and manage the work.
- Manages project budgets.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work seated for approximately 75% of a typical working day. Ability to work standing for approximately 25% of a typical working day.
- Ability to work in front of a computer screen and/or perform typing for approximately 75% of a typical working day.
- Ability to travel approximately 10% of working time.
- Bachelor's degree in Business Administration, Engineering, Information Technology, Management Information Systems or a related field.
- 7+ years of broad-based project management experience to include tracking and reporting responsibilities for a large project portfolio.
- 7+ years working in a client-facing project management role.
- 5+ years of experience in a medical device, quality, regulatory affairs, clinical affairs, operations, or related field.
- Demonstrated ability to balance cost, quality and schedule constraints while escalating issues as needed.
- Demonstrated ability to prioritize and balance multiple competing priorities within and across multiple projects at the same time.
- Demonstrated success with oral and written communications/presentations, influence and persuasion, results orientation, facilitation, and teamwork skills.
- Experience working in a matrix management organization with primary responsibility for project success while relying on a team of resources which may or may not be direct reports.
- Advanced proficiency with MS Project as well as MS Visio, Excel and PowerPoint.
- Authorization to work in the United States without sponsorship.
- Strategic planning experience.
- 5+ years of experience in medical technology or related field.
- 1+ years of experience with clinical studies.
- PMI Project Management certification.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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