Study Site Management Specialist – UK
FSP – Oncology-focused Pharmaceutical Company**
This role, under the guidance of Study Site Management leadership, is responsible for overseeing end-to-end site start-up activities, from feasibility to site closure. The Specialist serves as the primary contact for the site, country, and study team, supporting site-level feasibility assessments, site identification, qualification, and closure activities.
Duties and Responsibilities:
* Participate in site management meetings and track activities.
* Collect and review essential documents.
* Gather country and site-level intelligence.
* Manage submissions to Institutional Review Boards (IRBs) and Regulatory Authorities.
* Complete/manage site-specific activities needed for study activation.
* Oversee site-level Regulatory Green Light processing.
* Serve as In-House Study Lead for limited-scope studies and lead site management meetings.
Requirements:
* BA/BS degree in Business Administration, Science, or related field, or equivalent experience.
* 5 years in the biopharmaceutical/CRO industry.
* Strong presentation, documentation, and interpersonal skills.
* Proficient in MS Office, MS Project, and communication tools.
* Ability to manage multiple tasks and meet deadlines.
* Excellent planning, organizational, oral, and written communication skills.
* Knowledge of clinical research principles, FDA/EU regulations, and local healthcare systems.