Job Description

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

Position overview: The Clinical Project Manager (CPM) manages day-to-day operational and aspects of multiple projects simultaneously, including those of high-volume of data, increased risk, and complexity. The CPM has overall responsibility and accountability to successfully execute projects as defined by the governing protocol(s), and working closely with the Sr. Director of Clinical Affairs to facilitate decisions necessary for timely delivery of high-quality work products..

Essential Duties and Responsibilities:

• Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting and managing vendor, vendor contracts and ensuring expenditures are within budgetary guidelines.
• Leads planning and communication with cross-functional teams to ensure proper and timely execution of clinical projects, assigning individual responsibilities (as needed), identifying appropriate resources needed, and developing the project plan and schedule to ensure timely completion of project deliverables
• Manage the project teams and ensure the project tasks are in line with the project goals
• Monitor and oversee site initiation activities, and maintain documentation of process
• Schedule and deliver site training (via web or in person), as needed
• Prepare, oversee and review documents related to clinical study, and ensure required materials and/or equipment is available for delivery to sites
• Oversight and management of discrepant data handling, including the submission of queries to site/CRO for resolution and documentation
• Arrange or help in organizing clinical study meetings
• Ensure the availability of necessary resources for the execution of clinical projects
• Review and approve invoices being presented by study vendors and external consultants

Education:

• BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).

Required Experience:

• 6+ years of relevant clinical trial experience with associated skill sets.
• Clinical trial experience required of which 2 years must be in a project lead role
• Previous experience in the pharmaceutical industry/biotech. Biotech (a plus)
• Experience working with external vendors and Contract Research Organizations (CRO)

Knowledge, Skills, and Abilities:

• Prior work with clinical data management and EDC systems
• Experience working in a startup environment
• Experience with investigational device clinical trials
• Experience with interventional cardiology and/or heart failure therapeutic areas
• Ability to apply comprehensive technical knowledge of Interventional Cardiology to resolve complex issues in creative ways

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