R21578 Temp Clinical Study Specialist

Pay Range: 40 -50

This is a 1 year temp/contract role. Potential for extension.

Candidates must be able to work 2 days on-site in Tarrytown, NY/Armonk, NY or Basking Ridge, NJ. The other 3 days per week are from home.

Remote work option is not possible.

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).

In a typical day you would:

• Organize and deliver analyzable reports and metrics to the clinical study lead
• Schedule and coordinate meetings, prepare agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
• Collate data for assessments such as feasibility and site selection and reviews site usability database
• Contribute to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
• Compile 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
• Collate materials for training and investigator meetings
• Track site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
• Monitor and update investigator/site status for the trial, and supports with clinical trial registry postings
• Perform scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
• Ensure scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)
• Manage and maintain team SharePoint and/or shared drive sites, as needed
• Communicate with sites as directed and maintains site contact information
• Contribute to line listings review for Blind Data Review Meeting (BDRM)
• Track and monitor close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
• Participate in Standard Operating Procedures (SOPs) revisions or departmental initiatives
• Proactively recommend process improvement initiatives for the department
• May require 25% travel

To be considered, you must possess a Bachelor's Degree and 3 years of related pharmaceutical industry experience in Clinical Trial Management.

• 
  This is a contract position at Regeneron with Magnit Global being the Employer.
• To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.