Clinical Study Specialist

7 months 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 a hybrid position and must work onsite 3 days per week. Fully remote is not possible for this role.

**In this role, a typical day might include the following**:
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, enrollment 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

**This role might be for you if**:
You have a strong attention to details for the ability to track information and deliver on assigned study activities
You demonstrate strong communication and interpersonal skills; ability to form relationships internally and externally
You are resourceful and to demonstrate problem solving skills
You can proactively assess information and investigate impact on clinical trials
In order to be considered, a Bachelor’s degree with 2+ years of relevant pharmaceutical industry experience. In lieu of a Bachelor’s Degree 5+ years of relevant pharmaceutical industry experience is required with a focus in clinical operations or trial management.

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

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