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Clinical Trial Management Intern

2 months ago

Uxbridge, United Kingdom Regeneron Pharmaceuticals Full time

The CTM intern provides administrative support to the clinical study team (CST) responsible for clinical trial execution. The CTM intern may be assigned to support the execution of one or more studies across a program. The CTM intern receives assignments from the Senior Director CTM, Clinical Study Lead or Clinical Study Associate Manager. The CTM intern could support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).

JOB DUTIES:

  • Serve as the administrative support for the Clinical study team (CST) working in compliance with SOPs, FDA regulations, GCP and ICH guidelines
  • Attend regular CST meetings for one or more studies. Support the Clinical Study Specialist (CSS) to schedule and coordinate meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
  • Distributes materials to study sites, as directed
  • Assists with requesting, collecting, and reviewing site regulatory documents
  • Tracks site study start up status and activities using established study tools
  • Review, maintain, and reconcile (QC) essential study documents and electronic Trial Master File (eTMF) according to TMF plan
  • Collaborate with the eTMF lead to ensure completeness, quality and timeliness is followed by the study team
  • Supports and participates in tracking organization and maintenance of study reporting tools such as monitoring visit schedules
  • Collates and assembles study documents under guidance of the CSS or Clinical Study Lead (CSL) for study binders (regulatory, pharmacy, laboratory), study reference manuals, CRA training and Investigator Meeting materials, and study data collection tools
  • Supports the CSS to maintain team SharePoint and/or shared drive sites, as needed
  • May also support other projects within CTM as guided by the Senior Director CTM

JOB REQUIREMENTS:

  • Excellent interpersonal, collaboration and communication skills.
  • Highly proactive, self-motivated, and organised
  • Ideally experience in Microsoft Applications; Word, Excel, Outlook and PowerPoint.
  • Must be enrolled in a full-time program (Bachelor's, Master's, or PhD)
  • Must be enrolled in university full-time, following their work at Regeneron Pharmaceuticals Inc.
  • Must be confident in ability to work as part of a global team, with several key stakeholders based in US.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.