Class III Medical Devices. Our client is a leading provider of medical devices for non-invasive surgical treatment solutions. For their main office in Dallas, TX, they are looking for several seasoned Clinical Project Managers.
Skills and Qualifications:
- Bachelor’s degree required in medical/healthcare-related science field. Advanced degree preferred.
- 6-8 years of regulatory / global clinical trial experience (preferably in medical device industry), with at least 2 to 3 years of executing global feasibility, pivotal and post-approval trials.
- Preferably, ~ 5 years of experience with PMA Class III device process. Experience with global regulatory processes are welcomed. Experience with various international clinical trials regulations also desirable.
- Demonstrates current working knowledge of all phases of clinical trial development from concept through final Clinical Study Report and knowledge of operational and regulatory processes involved with clinical trials. Professional certification for clinical trials management is welcomed.
- In-depth knowledge of global clinical trial processes and regulations (US-FDA, ISO, Health Canada-ITA/CTA, and familiarity with Japan, China and South Korea).
- Manage successful execution of assigned global clinical studies in adherence to Good Clinical Practices (ICHGCPs) and in compliance with appropriate company Standard Operating Procedures (SOPs) as applicable under the Regulatory Agency(ies) governing the study, and any other applicable guidelines and regulations.
- Responsible for clinical operational oversight and execution of assigned trial(s) in order to achieve expectations of quality, timelines and budget, and study conduct.
- Manage successful Clinical Research and Clinical Trials submissions (as needed) to governing Regulatory Agency(ies) in full compliance with local regulatory laws
- Builds and sustains extensive global networks across multiple functions at study team level.
- Develop and share best practices to accelerate project timelines
- Develop professional relationships with investigational sites and key opinion leaders involved in assigned study(ies) to ensure appropriate stakeholder engagement and support.
- Manage site relationships and provide timely input to ensure that trials are executed according to the agreed project plan.
- Manage internal company relationships and maintain open communication to successfully meet projected trial timelines, trial execution and completion.
- Manage study team performance and CRO subcontractors to ensure adherence to agreed deliverables within timelines.
- When applicable, manage relationships with the governing Regulatory Agency, in collaboration with the local regulatory agencies. Ensure full compliance with global/local regulations.
- Hands-on management of assigned clinical trials to ensure that timing of all major trial milestones meets the plan. Specifically, track and evaluate trial milestones and monitor overall operational performance metrics through life of the trial. Identifies issues early and proposes and tracks solutions. Elevates critical issues to management and, whenever possible, resolves issues in a professional manner in accordance with company policies. Coordinates updates, including presentations/communications, on assigned trials to management. Coordinates protocol amendments and database changes within the study team and documents all changes for the regulatory files. Leads the change initiative with the sites in an orderly and efficient planned process.
- Works with internal CRO to ensure the trial risk assessment is complete, and that mitigation and contingency measures are prepared and implemented. Actively assesses potential risks to trial and implements mitigation plans, as needed.
- Develops key site relationships with the site personnel and serves as the key point of contact for operational and process related issues and inquiries for assigned trial(s).
- Takes specific responsibility to manage quality of clinical trial initiation, execution, recruitment efforts, coordination and oversight of monitoring activities, direct database management, and data analysis, including and not limited to successful database lock (DBL) and reporting; coordination of Data Safety Monitoring Board, as needed.
- Responsible for written regulatory/clinical communications for assigned trials, including, but not limited to protocol and CRF development, responds to regulatory deficiency letters, develops annual reports with safety reporting, SAE/UADE reports, final Clinical Study Reports, CE Mark reports, and other internal reports as needed.
- Liaise with vendors and internal stakeholders to ensure timely database lock is achieved.
Processes & Procedures
- Manage appropriate implementation, conduct, tracking and reporting of assigned trial(s) including quality review of trial information within internal clinical trial management practices used to support and manage assigned responsibilities.
- Identifies and assists with opportunities for process development, improvement and implementation of policies, procedures and processes related to Good Clinical Practice, SOPs, and assigned clinical trial activities.