Ergomed

Study Start Up Specialist

Raleigh, NC, United States

Sponsorship not specifiedDetected 16 hours ago

GCPLeadershipProblem Solving

About the role

Ergomed is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
We have nourished a true international culture here at Ergomed.
Come and join us in this exciting journey to make a positive impact in patient's lives.

Drive & Passion
Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
Prepare, collect, review regulatory information to support regulatory submissions for initial authorization and maintenance, in compliance with all applicable regulations.
Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation.
Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information.
Prepare study team reports or updates regarding status of essential document collection, review and approval.
Take ownership in contract negotiations with investigative sites or coordinate other team members assigned to perform contract negotiations as per study specific
Ensure all relevant documents are submitted to Trial Master File (TMF) for filing as per study specific guidance.
Support, mentor and train department staff and new-hires.

Arrange for and/or review translation of essential documents as required.
Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.

Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures.

Study Start Up Specialist takes leadership and acts as the primary point of contact for Sponsor and internal stakeholders during the study start-up process

This listing is sourced directly from Ergomed's careers page and normalized into a canonical job model.