Clinical Study Specialist

3 weeks ago

Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full time

The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
This role is hybrid with a minimum 3-day onsite requirement.

**A typical day in this role looks like**:
Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
**Compiles study manuals including but not limited to**: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)
Manages and maintains team SharePoint and/or shared drive sites, as needed
Communication with sites as directed and maintains site contact information
Contributes to line listings review for Blind Data Review Meeting (BDRM)
May manage or contribute to oversight of Third Party Vendors (TPV)
Tracks and monitors close out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
Proactively recommends process improvement initiatives for the department
May require 25% travel

**This role may be for you if you have**:
Attention to details for the ability to track information and deliver on assigned study activities
Good communication and interpersonal skills; ability to build relationships internally and externally
Ability to be resourceful and to demonstrate problem solving skills
Demonstrate the ability to proactively assess information and investigate impact on clinical trials
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Basic familiarity with medical terms and clinical drug development
Awareness of ICH/GCP
In order to be considered qualified, a minimum of a Bachelor’s degree with 2+ years of relevant experience, in a sponsor or CRO. Hematology or oncology experience is highly preferred.

Salary Range (annually) $90,700.00 - $148,100.00

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