Project Manager - Clinical

The SetPoint Medical Program Management team is seeking a highly motivated individual who will be responsible for using project management skills and processes to ensure successful execution of complex interconnected projects, with a focus on the successful ramp up and execution of clinical studies. The Clinical Project Manager serves as an effective team leader who manages and motivates team members using positive and productive methods of communication. This position reports to the Director of Program Management.


Job Responsibilities:

· Provide strategic/tactical planning, organization, and oversight of clinical study activities such as clinical site start up, budgeting, monitoring, regulatory reporting, vendor management, clinical supply management, and site payments

· Develop, maintain, and monitor project timelines and allocated resources throughout the life of the study and continuously analyze trial performance to plan 

· Ensure cross-functional coordination of project timelines directly with teams from Product Development, Quality Assurance, Clinical Affairs, Operations, Regulatory Affairs and Marketing 

· Perform risk management and contingency planning activities to ensure that all potential study risks, such as delays in study milestones and increased study costs, are managed in a proactive and efficient manner while appropriately escalating issues

· Develop dashboards and status reports as required

· Collaborate with senior management to provide up-to-date information regarding study progress, resourcing needs, and issues at regularly scheduled intervals 

· Identify and manage project scope and communicate changes in scope to the management team

· Provide direction and implementation of clinical operations standard operating procedures and best practices within the team to ensure compliance

· Manage clinical study budget, contracts, and payments

· Facilitate team coordination and workflow

· Lead project team meetings to ensure on-time deliverables

· Identify and assist in developing continuous process improvements based on experience and trends

· Participate in evaluation and selection of clinical study vendors including CRO, Data Management, IRT, Central labs, Imaging, etc.

· Stay abreast of new project management techniques, methods, and strategies

Skills and Abilities

· Able to recognize inter-relatedness of cross-functional study team activities and understand the impact of project decisions

· Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities

· Work collaboratively on cross functional teams to establish detailed and accurate schedules

· Attention to detail

· Excellent written and oral communication skills

· Analytical mindset:

o Ability to analyze and present data

o Ability to do basic research and present results

· Strong leadership, organizational and time management skills

· Willingness to travel up to 25% 

Minimum Qualifications

· Proven work experience as a Project Manager or similar role

· Experience working in the medical device, pharmaceutical or other regulated industry

Preferred Qualifications

· PMP certification

· Experience with Microsoft Project, Wrike or other scheduling tools

· Familiar with 21 CFR 820 and ISO 13485 requirements and practices

Salary Range: $95,000 - $135,000, depending on experience


Not available


Company Headquarters in Valencia, CA

Company Description:

SetPoint Medical is an early-stage medical device company developing the first implantable neurostimulation device for the treatment of chronic inflammation.