Clinical Project Manager

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.

The CPM may also assist other departments to execute post marketing studies of approved products either to comply with regulatory approval conditions or to generate additional clinical information for marketing purposes. This role is responsible for ensuring that the studies are conducted in accordance with the study protocol and Good Clinical Practice. The process includes interaction and communication with key project stakeholders, clinical sites, private-practicing orthodontists, and treatment coordinators related to case specific issues, status updates, budgets and timelines related to the project.

* 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.

* 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

* Ensure the team performs evaluations of potential investigational sites and investigators for participation in clinical trials (or limited releases)

* Is accountable for perform 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

* Prepare clinical trial language details and post on clinical trials.gov (as applicable)

* Lead team in the interactions with sites and data management team to resolve data queries and to ensure data integrity and completeness

* 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.

* Other duties may be assigned.

Additional responsibilities:

* Provides technical assistance to study sites regarding the conduct of clinical research

* 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

* Assists in writing annual and final clinical study reports

* Ensures accurate, up-to-date records of all documents and protocols of all clinical studies

* Follows all departmental and company procedures as indicated in quality, administrative, or other systems

* Ensures the effective fulfillment of objectives and deadlines assigned to the group.

* Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources.

* Participate in proactive team efforts to achieve departmental and company goals.

* Travel may be required - up to 25%

* Perform other duties as assigned.

Working Relationships:

* Internal:
Position interacts on a regular basis with all members of the Regulatory Affairs, Legal, Product Innovation, Marketing and with members of other departments as a representative to internal project teams as appropriate.

* External:
Position interacts with investigational site personnel including investigators, their staff,…