Sr. Clinical Operations Specialist

5 days ago

Hopkins, Minnesota, United States Laborie Medical Technologies Full time $80,000 - $120,000 per year

We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We're not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We're Looking For:

As a key member of the Clinical Affairs team, the Sr. Clinical Operations Specialist will support the clinical research team in managing all aspects of clinical study operations including, but not limited to, trial master file (TMF) and investigator site file (ISF) creation and maintenance, department-level end-to-end invoice processing and management, vendor and healthcare practitioner management, and investigator-initiated research and grant support.

About the Role:

  • Oversee the lifecycle of TMF and ISF documentation, ensuring organization, accuracy, and ongoing inspection readiness.
  • Lead quality control reviews, identify discrepancies, and resolve issues in collaboration with cross-functional teams.
  • Coordinate the preparation, distribution, and inventory management of essential study supplies (e.g., binders, tip cards) to ensure timely availability and compliance with protocol requirements.
  • Maintain up-to-date knowledge of regulatory standards (ISO-14155, ICH GCP, FDA) and ensure all activities adhere to applicable guidelines and SOPs.
  • Manage the coordination and administration of payments to investigators, clinical sites, vendors, and healthcare professionals (HCPs), ensuring accuracy, compliance, and timely disbursement.
  • Track and report payments in accordance with the Sunshine Act/Open Payments, collaborating closely with Finance, Legal, and Compliance teams.
  • Lead monthly accrual tracking and year-end accrual dissemination between clinical research teams and finance for assigned projects.
  • Serve as a primary point of contact for payment-related queries, working with internal and external stakeholders to resolve issues and ensure timely, accurate disbursement of funds.
  • Identify and implement process improvements to enhance documentation quality, payment workflows, and study material management.
  • Support additional clinical operations activities as needed.

Minimum Qualifications:

  • Bachelor's degree in the sciences, medicine, or similar discipline
  • 5+ years of clinical research or equivalent experience gained with a CRO, Pharmaceutical or Medical Device company
  • In-depth knowledge of GCP, ICH guidelines, ISO 14155, FDA and EU MDR regulations
  • Experience with financial management or equivalent
  • Strong interpersonal, verbal, and written communication skills
  • Strong organizational, analytical, and problem-solving skills

Preferred Qualifications:

  • Experience with interventional urology, urology, obstetrics, or gastroenterology medical devices
  • Experience with clinical trial management systems (CTMS), electronic TMF (eTMF), and payment tracking tools

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