Location: Dallas, TX
Our client is an emerging leader in non-invasive therapy medical devices.
- Manage successful execution of assigned global clinical studies in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs) as applicable to United States Food and Drug Administration (FDA) regulations, Health Canada, International Conference on Harmonization (ICH) guidelines and any other applicable guidelines and regulations.
- Responsible for clinical operational oversight and execution of assigned trial(s) in order to achieve successful delivery regarding expectations of quality, timelines,budget, and study conduct.
- Manage successful Clinical Research and Clinical Trials submissions (as needed) to Notified bodies, EU, and leading investigation centers 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 provides timely input to ensure that trials are executed according to agreed project plan.
- Manage internal company relationships and maintains 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 FDA/Health Canada and/or Notified Body in EU in collaboration with the local regulatory team. 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, tracks and evaluates trial milestones and monitors overall operational performance metrics through life of the trial. Identifies issues early and proposes and tracks solutions. Whenever possible, resolves issues that have been escalated and/or take issues to management. Coordinates updates, including presentations and communications, on assigned trials to management.
- Works with internal CRO to ensure 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.
- 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, oversight of monitoring activities, and direct database management, and data analysis, including and not limited to successful data base lock (DBL) and reporting.
- Responsible for written regulatory/clinical communications for assigned trials, including, but limited to protocol and CRF development, responses to regulatory deficiency letters, 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 data base lock is achieved
PROCESSES & PROCEDURES
- Manage appropriate implementation, conduct, tracking and reporting of assigned trial(s) including quality review of trial information using internal clinical trial management practices 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.
SKILLS AND QUALIFICATIONS:
- Bachelor’s degree required in medical/healthcare-related science field. Advanced degree preferred.
- Legally able to work in the U.S. and travel abroad.
- 6-8 years of regulatory / global clinical trial experience (preferably in medical device industry), with at least 2 to 3 years executing global feasibility, pivotal and/or post-approval trials.
- Preferably, some experience with PMA Class III device processes. Experiences with CE Mark, ISO, EMA or other international regulatory processes are welcomed.
- Demonstrates current working knowledge of all phases of clinical trial development from concept through final. Experience with electronic data capture and databases including but not limited to Oracle Clinical and Medidata
- Proficient with MS Word, Powerpoint, and Excel including data import /export management and descriptive data analysis
- Demonstrated technical competence and experience in design, implementation, tracking and completion of global clinical trials
- Knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results.
- Ability to collaborate, align and manage diverse, global cross-functional matrix teams.
- Able and willing to travel as needed, including international travel.
- English is a MUST.
- Bilingual in Spanish or French strongly preferred.
- Knowledge of global clinical trial processes and regulations (US-FDA, EU CE Mark, EMA, and Health Canada-ITA/CTA,).
- Understanding of principles, implementation and maintenance of regulations.
- Knowledge of global trial planning and management principles.
- Demonstrates current working knowledge of all phases of clinical trial development from concept through final CSR and knowledge of operational and regulatory processes involved with clinical trials.
You may send your CV and application directly to firstname.lastname@example.org