Principal Clinical Research PM

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

📋 Description

• Oversee designated departmental projects and activities related to aortic arch repair technologies, including the execution of investigational device exemption (IDE) studies.

• Act as the primary lead for clinical studies, managing stakeholder communication, team leadership, timelines, budgets, and resolving issues.

• Facilitate cross-functional study team meetings and promote accountability among both internal and external partners.

• Manage study vendors, which includes qualification, onboarding, contract management, budgets, invoicing, and escalation of operational issues.

• Formulate the clinical strategy for IDE studies.

• Collaborate effectively with Regulatory, Quality, R&D, and Commercial stakeholders.

• Supervise clinical site operations to ensure compliance with protocols, contracts, GCP, and regulatory standards.

• Lead the creation, review, and maintenance of clinical documentation, such as protocols, study management plans, informed consent forms, case report forms, SOPs, and amendments.

• Oversee study steering and safety committees.

• Plan and assist with quality initiatives to ensure study readiness and data analysis.

• Support the development of abstracts, manuscripts, and scientific presentations.

• Prepare and finalize clinical study reports.

• Create and deliver presentations related to the study.

• Provide technical training and respond to clinical or customer-related inquiries.

• Facilitate regulatory submissions, including annual FDA reports.

• Review technical and marketing materials to ensure scientific accuracy and compliance with regulations.

• Identify, evaluate, and mitigate device risks in collaboration with Quality and Risk Management partners.

• Assist with site recruitment, investigator meetings, and site training efforts.

• Conduct basic statistical analyses for product lines and support clinical decision-making.

• Perform literature reviews and prepare scientific summaries.

• Attend national and international surgical and scientific congresses.

• Execute additional assigned responsibilities, including tasks beyond the current title level.

⛳️ Requirements

• A minimum of a Bachelor’s degree; a Master’s degree in a relevant field is preferred.

• At least 10 years of experience in clinical research or a related field, or an advanced degree with 8 years of relevant experience.

• Experience with aortic repair technology, such as surgical grafts and endovascular devices, is highly desirable.

• Experience with investigational device exemption (IDE) studies is highly desirable.

• Experience working within a medical device company is highly desirable.

• Proven project management, critical thinking, and communication abilities.

• Demonstrated statistical and computer skills, including proficiency with spreadsheets, relational databases, and intermediate to advanced statistical analysis.

• Exceptional written and verbal communication skills.

• Strong knowledge of medical terminology.

• Willingness to travel.

🏝️ Benefits

• Opportunity to travel.

• Chance to attend national and international surgical and scientific congresses, whether in person or remotely, as required.