Clinical Project Manager

About the role

This position is ideal for experienced and detail-oriented professionals who are interested in joining the Global Clinical Affairs team as a Clinical Project Manager. Partnering with cross-functional teams (such as R&D, Marketing, etc), as well as internal and external customers, you’ll help lead and manage projects to ensure clinical studies and activities are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials or limited release meets the regulatory requirements for approval.

Responsibilities

• Define project scope, develop timelines and budgets, and assemble the study team clinical affairs activities (including but not limited to clinical studies, limited releases, focus groups, data collection activities, etc)
• Ensure the trial adheres to all regulations (e.g., ICH-GCP, FDA, EMA) and maintain high-quality data collection and documentation
• Oversee the study budget, manage expenses, and ensure necessary resources are available for the project
• Career Development
• Coordinate cross-functional teams, lead the project team, and manage relationships with external vendors like Contract Research Organizations (CROs)
• Independently assess and determine the most efficient methods for conducting the study and collaborations needed with internal and external stakeholders, utilizing a variety of strategies and tools to ensure the study stays on track
• Act as the primary point of contact for stakeholders, providing regular status reports and facilitating communication between teams and sponsors
• Oversee all aspects of the trial, from site activation and participant enrollment to data monitoring and final reporting
• Identify and think critically to resolve issues that may arise to ensure the study (and the Clinical Affairs team) stays on track
• Accountable for performing auditing of investigational sites and investigators to ensure data integrity and protocol compliance
• Assist Clinical Research team with negotiating and obtaining approval for investigator agreements
• Lead in the education, training and support of investigators and their staff prior to and during clinical trials of investigational devices (or limited releases of approved products)
• Lead the effort in development of clinical protocols, case report forms, informed consent forms, investigator manuals, product instructions for use, and study training materials
• Prepare and finalize clinical documents for IRB submission and obtain IRB approvals
• Lead team in the interactions with sites and data management team to resolve data queries and to ensure data integrity and completeness
• Track data report forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites
• Oversees delivery and shipment of aligners for clinical studies
• Aids in writing annual and final clinical study reports
• Ensures accurate, up-to-date records of all documents and protocols of all clinical studies
• Fulfills objectives and deadlines assigned to the group
• Complies with all safety policies, practices and procedures
• Reports all unsafe activities to supervisor and/or Human Resources
• Participates in proactive team efforts to achieve departmental and company goals
• Travel may be required – up to 25%

Requirements

• Bachelor of Science, or equivalent experience, required
• Masters of Science preferred
• 6-10 years’ experience in clinical research industry preferred
• 2-5 years experience as Senior Clinical Research Associate Dental industry experience preferred
• Experience running clinical studies from a project management perspective required
• Experience with SaMD clinical studies is preferred
• Person must have excellent organizational skills and pay extreme attention to detail
• Person must have excellent interpersonal and oral/written communication skills and be able to work independently

Qualifications

• Familiarity with applicable FDA regulations
• Ability to think critically and scientifically
• Ability to give presentations and updates on clinical research/studies
• Ability to write clinical reports and protocols
• Ability to communicate effectively
• Proactive mindset and strong drive to take initiative, actively seek opportunities and solutions
• Go-getter attitude to take on challenges with determination and strive to deliver quality results
• Excellent presentation and communication skills
• Ability to work both independently and collaboratively

Skills

• Ability to think critically and scientifically
• Ability to give presentations and updates on clinical research/studies
• Ability to write clinical reports and protocols
• Ability to communicate effectively
• Proactive mindset and strong drive to take initiative, actively seek opportunities and solutions
• Go-getter attitude to take on challenges with determination and strive to deliver quality results
• Excellent presentation and communication skills
• Ability to work both independently and collaboratively

Benefits

• Family Benefits
• Career Development
• Other Insurance
• Legal, Critical Illness, Voluntary Accident, Long-Term Care, Auto, Home and Pet Insurance