Clinical Project Manager

The Clinical Project Manager (CPM) Contingent Worker is responsible for leading the operational execution of clinical studies. As a key member of the Global Clinical Affairs (GCA) team, the CPM oversees all phases of clinical study delivery, from protocol development to final reporting, ensuring execution within defined timelines, budgets, and quality standards. In this role, the CPM will regularly collaborate with GCA Study Team members (Clinical Operations, Clinical Data Management, Biostatistics, and Clinical Scientists) as well as cross-functional stakeholders and external study vendors.

Responsibilities:
Clinical Study Leadership

• With minimal supervision, lead global clinical study teams from clinical protocol design to final clinical study report within assigned budget, scope and timeline requirements. Serves as the primary point of contact for operational oversight of assigned clinical studies.
• Utilizes project management tools effectively for organizing team meetings, maintaining action and decision logs, and facilitating effective decision making.
• Provides study updates to GCA management and project stakeholders as needed

Study Planning and Execution

• Leads development of clinical 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.) are aligned to protocol objectives and include operational efficiencies.
• Actively tracks study progress to ensure that enrollment targets, data quality, and study milestones are met.
• Effectively manages external vendors as needed, to complete clinical studies.
• Communicates direction and updates to clinical study team members, assign tasks as appropriate, and ensure that commitments are met.
• Ability to proactively identify study risks and works to mitigate them or create contingency plans.

Documentation & Compliance

• Maintain regulatory compliance, ensure accurate and timely documentation of the essential study documents within the Trial Master File (TMF).
• Ensure all study activities adhere to regulatory requirements, ethical guidelines, and company policies.
• Other duties as needed or required

Essential Functions of the Role:

• Excellent oral and written communication skills
• Strong interpersonal skills
• Demonstrated ability to work independently, as well as part of a multifunctional study team
• Ability to work on multiple concurrent studies and independently balance priorities to meet timelines
• 2-5 years of relevant experience

Education Requirements

• Bachelor’s degree in Life Sciences or related field. Equivalent combination of education, training and work experience may be accepted in lieu of degree.
• PMP (Project Management Professional) Certification preferred

Specialized Skills/Technical Knowledge:

• Strong working knowledge of project management methodologies and tools (e.g., Microsoft Project).
• Understanding of relevant clinical research regulations (GCP, EUMDR, ISO)
• Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams)
• Knowledge relating to continence care, critical care and/or ostomy a plus

Pay Rate Range: $50-65/hr depending on experience