Location: Dallas
Reporting to: Regional Director, Clinical Affairs – Europe

Responsibilities:

• • Manage successful execution of assigned global clinical studies in adherence to Good Clinical Practices (ICH/GCPs) 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
  • Relationships
  • 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 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 stakeholders 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.

Minimum requirements/qualifications:

• • Bachelor’s degree required in medical/healthcare-related science field. Advanced degree preferred.
  • Minimum 5 years of 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.
  • Familiar with electronic data capture tools such as Oracle Clinical and Medi-Data to Excel data import /export management and descriptive data analysis
  • Proficient in technical writing and critical thinking with a demonstrated ability to design and implement projects at a global scale.
  • 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

Knowledge Desired:

• • Professional in English is a MUST.
  • In-depth knowledge of global clinical trial processes, regulations, and management (FDA CFR, ICH GCP, ISO 14155, and EU MDD/MDR).
  • Bilingual is highly desired (Spanish or Italian preferred)
  • Proficient with MS Word, Excel, Power Point, Acrobat, and various EDC systems
  • 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.

Please click here to apply.