Clinical Study Specialist

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).

A typical day will include the following:

• Coordinates 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

This role may be for you if:

• You perform scheduled reconciliations of study Trial Master File (TMF)

• You can handle and maintain team SharePoint and/or shared drive sites, as needed, and participate in Standard Operating Procedures (SOPs) revisions or departmental initiatives

• You proactively recommend process improvement initiatives for the department

• You have attention to detail, to track information and deliver on assigned study activities

• Good communication and interpersonal skills; ability to establish relationships internally and externally

To be considered for this opportunity, you must have a minimum of a Bachelor's degree with 2+ years of life science experience with a focus in clinical operations or trial management. This job is on-site at one of our locations two days per week and the other three days are work from home.

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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.

Salary Range (annually)

$88,500.00 - $144,500.00