Clinical Operations Lead

Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with minimal side effects.

If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.

General Accountability:

The Clinical Operations Lead will provide comprehensive operational and administrative support across multiple clinical trials. The role is dedicated to ensuring efficient and compliant execution of sponsored trials from startup to closeout.

Duties and Responsibilities:

• Coordinate clinical operations during startup, maintenance, and closeout phases
• Negotiate clinical trial agreements/budgets and liaise with ethics boards, working closely with study sites to accelerate activation
• Serve as the primary point of contact for study sites, investigators, and vendors
• Support cross-functional teams to resolve data queries
• Support financial tracking and reporting
• Facilitate completion of close-out activities ensuring accurate archiving
• Coordinate with cross-functional teams such as clinical operations, data management, and regulatory affairs
• Ensure clinical trials adhere to protocols, ethical guidelines, and regulatory requirements
• Identify and mitigate risks that could impact project success
• Prepare and present project status reports
• Establish and maintain the Trial Master File (TMF) ensuring copies of study documents, including protocols, ethics approvals, patient-facing materials, and site training and qualification are current and compliant
• Ensure the study conduct, TMF and adverse event reporting are compliant with ethics board approval, Good Clinical Practice (GCP) guidelines and applicable regulatory requirements
• Gather analytics on clinical trial progress to ensure integrity of data collection and track project milestones
• Provide support to Senior Clinical Management Team
• Conduct training for colleagues or study team as requested
• Fulfill other duties as required, including but not limited to tracking inventory and supplying study sites

Education and Certification:

• Bachelor's degree in health or biomedical sciences; Master's degree preferred
• Strong preference is given to candidates with SOCRA/CCRP or ACRP certification

Key Attributes (experience, skills and technical knowledge):

• Minimum 5 years professional experience in clinical research or trial support
• Knowledge of clinical trial operations and regulatory standards (e.g., GCP, ICH)
• Strong organizational and project management skills
• Ability to thrive in fast-paced environment
• Outstanding communication and interpersonal skills
• Proficiency in Microsoft Office Suite and clinical trial management systems is preferred
• Ability to manage multiple tasks simultaneously and adapt to shifting priorities
• Experience working with cross-functional teams and familiarity with contracting and budget management in clinical trials settings

We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.

We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.