We are a pioneer and a world leader in Rare Diseases. In 2017, we celebrated 20 years of bringing life changing therapies to our patients, many whom are children.
CenterWatch, a leading source for global clinical trial information, has named us one of the fastest drug developers in the industry. On average, we can bring treatments to market 12 months faster. For our patients, one year can make a lifetime of a difference. Clinical Operations plays a critical part in creating a sense of urgency tied to our purpose: To deliver new therapeutic options, as fast as we can, to our patients by ensuring proper planning, conduct, monitoring and data quality from study start-up to close-out. Our department is proud to foster rich communication and collaboration between study sites, and key stakeholders in the clinical trial ecosystem.
We are currently looking for the best and brightest talents to join our team. The ideal candidate would be a clinical research professional passionate about operations with up 4 years’ experience in Clinical Operations, focused on working to ensure delivery of quality data, and committed to helping our patients. A proactive problem solver who shows flexibility and an ability to communicate efficiently.
The Sr. Clinical Trial Specialist (Sr. CTS) performs essential responsibilities for successful trial execution. He/She takes on the key role of Study Specialist in the operational team, contributing to, or leading tasks related to study management and oversight activities. This may include contributing to and/or supporting study matters that impact study timelines, quality and budget.
Following demonstrated success in the Study Specialist role, the Sr. Clinical Trail Specialist may have the opportunity to take on regional operations responsibilities including managing issues and opportunities that impact regional study timeline, quality and budget; overseeing the CLO team, vendors and CRO for the study in the region; and escalating regional decisions, issues and risks.
Key responsibilities for this position include:
Manage and track vendor adherence to SOW and oversight plan for assigned vendors
Lead protocol deviation meetings, if assigned
Contribute to or be responsible for the development of vendor specific timelines ensuring alignment with study level timelines
Contracts & Budgets:
Manage Change Order and Change Negotiation Form (of vendors) processes, in collaboration with Business Operations
Review and approve invoices for assigned vendors
Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing
Clinical Operations Managed Vendors:
Drive day-to-day management of assigned vendors
Communicate study performance expectations to vendors, manage and track vendor performance metrics at a study level
Study startup, conduct and close-out:
A diverse set of operational responsibilities related to the startup, the conduct and the close-out of clinical trials
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.