Clinical Trials Manager

2 months ago

Union City, United States XII Medical Full time

Company Summary: XII Medical is an innovative medical device company working on developing a next generation neurostimulation system for treating obstructive sleep apnea. The next-generation system aims to increase patient compliance by reducing surgical invasiveness and improving the patient’s sleeping habits.


Job Summary: The Clinical Trial Manager (CTM) will be responsible for overseeing all aspects of our clinical trials, from study planning through study closeout. This role involves working cross-functionally with clinical research associates (CRAs), project managers, regulatory teams, and other stakeholders to ensure compliance with regulatory requirements, timelines, and budgets. The CTM will be expected to manage multiple clinical trials simultaneously, ensuring high-quality execution, adherence to protocol, and successful completion.


Key Responsibilities:

  • Lead the planning, implementation, and management of clinical trials from start-up to closeout, ensuring studies are conducted according to protocol, ICH-GCP guidelines, and regulatory requirements.
  • Develop and manage study timelines, budgets, and resources to ensure efficient execution of clinical trials.
  • Collaborate with cross-functional teams, including regulatory affairs, data management, biostatistics, and clinical operations, to ensure successful trial execution.
  • Oversee the selection, qualification, and management of clinical sites and vendors, including CROs, electronic data capture (EDC) systems, laboratories, and other service providers.
  • Prepare and review clinical study documents, such as protocols, informed consent forms, case report forms, investigator brochures, and clinical study reports.
  • Ensure timely and accurate submission of study-related documents to regulatory authorities and ethics committees.
  • Monitor clinical trial progress, track milestones, and provide regular updates to senior management and stakeholders.
  • Identify and resolve any issues related to patient recruitment, site performance, protocol deviations, and data quality.
  • Conduct site monitoring visits, including initiation, interim, and closeout visits, to ensure compliance with the study protocol and regulatory requirements.
  • Lead and manage internal and external audits and inspections.
  • Mentor and train junior team members, as we grow, to ensure a high standard of clinical trial conduct.


Qualifications:

  • Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
  • Minimum of 5 years of experience in clinical trial management, preferably within the medical device industry.
  • In-depth knowledge of clinical research regulations, including ICH-GCP, ISO 14155, and applicable FDA and EU regulations.
  • Proven track record of successfully managing multi-center clinical trials from start to finish.
  • Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
  • Strong organizational and project management skills with the ability to manage multiple tasks and priorities.
  • Excellent written and verbal communication skills, including the ability to effectively present information and respond to questions from stakeholders.
  • Ability to work independently and collaboratively in a fast-paced, dynamic environment.
  • Willingness to work from the Union City office up to a week per month.
  • Willingness to travel up to 20-30%, including internationally, as needed.


Preferred Qualifications:

  • Master's degree in a related field.
  • Certification in clinical research (e.g., ACRP, SOCRA).
  • Experience working with Class II and Class III medical devices.
  • Familiarity with medical device development processes and regulatory submissions.

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