Clinical Project Manager

• Leads study teams; manages, facilitates and documents team meetings (e.g. meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making
• Responsible for building and maintaining accurate study budgets and timelines.
• With minimal supervision, plans and manages global clinical studies within budget, scope and timeline requirements.
• Executes and communicates high quality, integrated cross-functional plans for clinical studies.
• Leads development of clinical study protocols by working collaboratively with clinical affairs team and key stakeholders. Ensures supporting documentation (i.e. case report forms, monitoring plans, data management plans, etc.) support protocol objectives and operational efficiencies.
• Provides study updates to senior clinical management, project stakeholders and to business unit/corporate management.
• Actively tracks study data analysis and publication activities.
• Ensures completion of timely clinical study reports for use by internal and external customers.
• Maintains strong relationships with study sites and clinicians.
• Effectively recruits, qualifies, contracts and manages Contract Research Organizations (CROs), as needed, to complete clinical studies.
• Ensures regular review, summary and reporting of accurate clinical study progress to Global Clinical Affairs team, stakeholders, project teams, regulatory and marketing teams throughout the course of a study.
• Communicates direction and updates to clinical study team members, assign tasks as appropriate, and ensure that commitments are met.
• Act as mentor to clinical operations team members and has expertise in the operational delivery of a clinical study.
• Proactively identifies study risks and works to mitigate them or create contingency plans.
• Other duties as needed or required.

• 5-8 years overall experience
• Bachelor of Science Degree and a minimum of 5 years relevant experience
• PMP (Project Management Professional) Certification a plus
• ACRP Certification(s) a plus: CRC, CRA, Medical Device Professional, and/or Project Manager Subspecialty
• Clinical project management track record with a working knowledge of project management tools and best practices (e.g., Microsoft Project)
• Experience in Medical Device, Pharmaceutical, or related field a plus
• Experienced in managing global clinical trials and in leading a clinical study team
• Excellent communication skills, both written and verbal
• Ability to progress a study with minimal guidance; Initiative and drive for results
• Demonstrated ability to collaborate and interact effectively on a cross-functional team (represent Clinical Affairs)
• Experienced in the operational execution of clinical studies, including the management of study files
• Demonstrated understanding of creating and communicating an accurate clinical budget
• Organizational, leadership, risk identification and problem solving skills
• Experienced in protocol development, study management, and study reporting
• Sitting for extended periods of time.
• Dexterity of hands/fingers to operate a computer keyboard, mouse, and other devices and objects.
• Physically able to participate in and conduct training sessions, presentations, and meetings.
• Travel up to 10%

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