Clinical Study Associate Manager

Clinical Study Associate Manager (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery.

This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs). The balance of direct execution versus oversight of CROs deliverables will vary accordingly.

The individual will work with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron Standard Operating Procedures (SOPs).

Travel to study sites may be required to assist with monitoring clinical studies.

A typical day might include the following :

• Planning and running a clinical study in an assigned region(s) in alignment with the global study plans
• Contributing to risk assessment and helping to identify risk mitigation strategies
• Supporting feasibility assessment to select relevant regions and countries
• Supervising and giving input to the development of study specific documentation e.g. case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc
• Providing regular status reports to team members as requested by the CSL
• Contributing to development and implementation of recruitment and retention strategies, and monitoring these accordingly

This role may be for you if :

• You are an excellent communicator with strong interpersonal skills, and capacity to establish relationships internally and externally
• You have a data driven approach to executing and problem solving
• You have a good attention to detail to deliver on specific study activities
• You are proactive and self-disciplined, and an ability to meet deadlines with an effective use of time
• You have budget awareness with the ability to get involved in various aspects of budget management

To be considered for this role you must have a Bachelors degree and 4+ years industry related work experience. Less experience with an advanced degree may be considered.

We must have candidates who have vendor management experience, as well as experience in clinical trial operations including developing key study documents.

We also require someone who has technical proficiency in trial management systems, Microsoft applications and TMF, as well as familiarity with medical terms, and a knowledge of Good Clinical Practice and regulatory guidelines.

Up to 25% travel may be required.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.

S. law and apply to U.S.-based positions. For roles which will be based in Japan and / or Canada, the salary ranges are shown in accordance with the applicable local law and currency.

If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.

The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$106,200.00 - $173,200.00