Senior Clinical Project Manager

JOB SUMMARY:

• Manage at least one primary project; Depending on the scope and phase of the project may support multiple projects.
• Provide project management expertise throughout the development and implementation of clinical studies. Interact with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables.
• Oversee operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations.
• Facilitate communication between R&D, Regulatory Affairs, Sales and Marketing, Training, Senior Management, and investigational sites by conducting team meetings, drafting, and sending routine correspondence (e.g., newsletters), and by presenting regular updates to management staff. 
• Plan, direct, create and communicate clinical study timelines.
• Oversee compliance to study requirements; Reviews compliance to protocol and elevates critical protocol deviations; Reviews monitoring reports.
• Lead team through clinical compliance initiatives and audits.
• Own and manage clinical trial budget, including scenario analysis, periodic budget reviews, and forecasting.
• Work with external vendors and suppliers such as clinical core labs in contract development and negotiation as well as in providing solutions to difficult problems associated with specific projects.
• Interact regularly with Principal Investigators and Key Opinion Leaders, Coordinate investigator and research coordinator meetings.
• Support and mentor junior-level project managers.
• Work on other non-trial-related activities such as process and procedure teams.  

EDUCATION AND EXPERIENCE:

Required:

• Bachelor’s Degree (Engineering or Sciences preferred).
• At least 3 years of direct project management (or at least 5 years of related) work experience.
• At least 2 years of medical device (or related) work experience.

Preferred:

• Advanced degree in a related field.
• Strong verbal communication and interpersonal skills, experience hosting large project meetings, and driving engagement.
• Effective written communication skills and ability to write professional/technical internal and external communications without oversight.
• Experience in the cardiovascular therapeutic areas for both pre-market and post-market clinical trials.
• Applicable knowledge of clinical trial regulations for both US and OUS.
• Demonstrated leadership/management skills with respect to achievement of company goals and objectives.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Solve complex problems within areas of responsibility that require ingenuity and creativity.
• Ability to leverage and engage others to accomplish projects.
• Multitasks, prioritizes, and meets deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.