Sr. Clinical Operations Specialist
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 our 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 record 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 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:
- Bachelors' 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, obstetrics, or gastroenterology medical devices.
- Experience with clinical trial management systems (CTMS) or electronic TMF (eTMF), and payment tracking tools.
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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