Principal Upstream Clinical Program Manager

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Offers strategic leadership for upstream clinical programs, collaborating with key stakeholders to create clinical studies that align with essential business objectives, which may encompass the following:

• Gathers clinical safety and performance data to fulfill regulatory requirements in major regions.

• Acquires clinical data to satisfy post-market obligations (e.g., CPT code applications, marketing claims, etc.).

• Facilitates cross-functional alignment on CRF and data strategy, guaranteeing the collection of high-quality, decision-grade data that satisfies regulatory, scientific, and business requirements.

• Collaborates with R&D, Professional Education, and Medical Affairs to assist in the development of procedures for new indications.

• Aids in the planning and coordination of clinical advisory boards to direct research efforts as necessary.

• Supports the Regulatory Affairs and Quality Assurance teams in preparing for reporting and submissions.

• May assist with internal and external audits.

• Cultivates and maintains robust relationships with physician collaborators.

⛳️ Requirements

• Bachelor’s degree is mandatory, preferably in Science, Medicine, or a related field; an advanced degree is highly preferred.

• At least 8-10 years of progressive experience in medical device clinical studies, with a minimum of 3 years preferred in neurology.

• Familiarity with, and experience in, the FDA and EU regulatory frameworks, with a preference for those who have supported global clinical strategies.

• Outstanding written and verbal communication skills.

• Strong analytical, critical thinking, and problem-solving abilities, with the capability to interpret and analyze data effectively.

• Proven collaboration and leadership skills.

• Capable of engaging in high-level technological and clinical discussions.

• Able to articulate complex technologies in clear, understandable terms.

• Proven ability to forge and maintain relationships both internally and externally.

• Demonstrated skill in effectively prioritizing multiple tasks and deadlines, with excellent follow-through abilities.

• Established track record of translating strategic plans into prioritized product, development, and/or operational objectives.

• Proven capacity to manage changing priorities in a fast-paced environment while maintaining clear communication with team members and management.

• Proficient in Microsoft Office Suite, including Word and PowerPoint.

🏝️ Benefits

• Health, dental, and vision insurance.

• Life insurance.

• Short-term and long-term disability insurance.

• 401(k) plan.

• Paid time off.