Clinical Program Manager

Strategic Staffing Solutions International’s client is a leading healthcare company specializing in the development and distribution of chronic condition monitoring systems for individuals and healthcare providers worldwide.

The company has already changed millions of lives and is poised to impact millions more with its future goal of becoming a leading consumer health technology company, all while continuing to develop solutions for serious health conditions.

By joining the company as a Clinical Program Manager you will provide leadership and direction to Clinical Affairs in planning and execution of clinical strategies in a key business area. A successful leader in this role will understand and translate business strategy into planning an execution of clinical studies to support broader objectives.

Excellent communication skills are required to manage and facilitate collaborations within the Clinical Affairs team, with all internal core team functional groups, and with external partner stakeholders. This role requires a strong technical background and experience in both product development and clinical study planning and execution, ideally in a regulated environment such as medical device development.

Where You Come In:

• You will serve as a member of core team(s), providing strategic direction to study teams to meet goals and timelines
• You will interface with representatives from key functional groups including Executive Management, Product Development/R&D, Regulatory Affairs, Quality Assurance, and Operations as well as Clinical Research Organizations (CROs) to set operational direction and strategy for clinical study activities.
• You will work in collaboration with functional leaders to design/implement strategies and track project plans related to study design
• You will drive the full spectrum of the clinical execution from the design phase to close-out in collaborating closely with the study team.
• You will track and manage strategic study operations including KPIs, study timelines, all budgetary and financial information, etc.
• You will coordinate and prioritize activities amongst trials/establish study milestones to ensure timelines are met
• You will recommend and implement innovative ideas to increase efficiency and quality of study management activities
• You will identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion
• You will drive selection of Contract Research Organizations (CROs) through competitive bid process and other necessary vendors to support study requirements
• You will provide oversight and execution of CRO study deliverables to ensure that objectives are met

What Makes You Successful:

• Bachelor’s degree in biological sciences or related medical/scientific field with a minimum 5-8 years leading clinical studies
• You have a strong regulatory knowledge, including Good Clinical Practices (GCPs).
• You have experience with protocol and ICF development.
• You have experience with clinical study planning and execution in the medical device industry.
• You have exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• You have excellent communication (written and verbal) and presentation skills along with leadership qualities.
• You have strong interpersonal skills and ability to work effectively on cross-functional & global teams.
• You thrive in an extremely fast-paced environment.
• Successful experience managing outside CRO groups in Class II/III, preferably diabetes, device studies would be an advantage
• Proficient with MS Office Suite (Excel, Word and PowerPoint), MS Project, and Smartsheet would be an advantage

What You’ll Get:

• A comprehensive onboarding and training on the job
• Opportunity to work in a diverse and inclusive environment with colleagues representing 45 different nationalities
• Hybrid working model, offering the flexibility to work both remotely and in a modern, well-equipped office space
• 5 additional vacation days, with potential for more for parents, students, and other cases with approval
• Opportunity to work from other countries for up to 30 days per year
• Health Insurance including reduced premiums available for dependents
• Life and Accident insurance coverage
• 3rd Pillar Private Pension plan
• Health and Wellness programs, including access to online coaching and therapy sessions
• Fertility, Family forming, Menopause and Men’s health support services
• Regular team-building events that foster collaboration and connection
• Best-in-class training and career development programs
• Exclusive discounts on restaurants, spas, clothing, gyms, entertainment, and more
• Access to a fitness tracking app with rewards for staying active
• Free parking space at the city center office location.