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Clinical Operations Specialist

Minnetonka, United States

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 Clinical Operations Specialist will support the clinical research team in 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, and management of key study supplies and materials.

About the Role:

Support the management of the TMF and ISF documentation lifecycle, ensuring organization, accuracy, and inspection readiness.
Conduct quality control reviews and resolve discrepancies 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.
Stay current on regulatory standards (ISO-14155, ICH GCP, FDA).
Coordinate the administration of payments for investigators, sites, vendors, and healthcare professionals (HCPs), ensuring accuracy, compliance and timely disbursement for the department.
Coordinate payment tracking and reporting (e.g., Sunshine Act/Open Payments) in collaboration with Finance, Legal, and Compliance.
Support monthly accrual tracking and year-end accrual dissemination between clinical research teams and finance for assigned projects.
Coordinating and processing payments to investigators, clinical sites, vendors, and consultants in compliance with study protocols and applicable regulations.
Collaborating with internal and external stakeholders to address payment-related queries and ensure timely and accurate disbursement of funds.
Support other activities as needed

Minimum Qualifications:

Bachelor's degree in the sciences, medicine, or similar discipline
At least one year of industry experience in clinical research or equivalent experience gained with a CRO, Pharmaceutical or Medical Device company
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 preferred

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

Paid time off and paid volunteer time
Medical, Dental, Vision and Flexible Spending Account
Health Savings Account with Company Funded Contributions
401k Retirement Plan with Company Match
Parental Leave and Adoption Services
Health and Wellness Programs and Events
Awarded 2024 Cigna Healthy Workforce Designation Gold Level

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.

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