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Senior Manager Clinical Study Lead

2 months ago

Uxbridge, United Kingdom Regeneron Full time

As a Senior Clinical Study Lead (SCSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studies outsourced to CROs, so we need a SCSL who has experience managing Third-Party Vendors. We need someone who can also contribute to and drive process improvement initiatives that support our rapidly growing organization. This is an exciting time to join our organization and have a direct impact on bringing life-saving treatments to the market.

As a SCSL, a typical day might include the following:

  • Providing operational input into protocol development:

  • Leading all aspects of and contributing to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.

  • Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.

  • Ensuring compliance with the clinical trial registry requirements

  • Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results

  • Leading risk assessment and identifies risk mitigation strategies at the study level

  • Managing feasibility assessment to select relevant regions and countries for the study

  • Conducting site evaluation and selection

This role might be for you if:

  • You have direct management experience with demonstrated results building and developing outstanding teams

  • You have the capacity to understand and implement the strategic direction and guidance for respective clinical studies

  • You can take a proactive and self-disciplined approach to managing projects with a developed ability to meet deadlines and prioritize

  • You have a history of effectively leading and negotiating with vendors

  • You have a data-driven approach to planning, executing and problem solving

  • You operate with a high degree of cross-functional agility using exceptional influencing and interpersonal skills

  • You have the innate ability to rally disparate groups to accomplish lofty shared goals

To be considered for this opportunity you must possess a Bachelorsâ degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of some relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered.

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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.