Temp - Manager, Clinical Study Lead - Phase IV Non-Interventional

Location
Tarrytown, NY, United States
Posted
Sep 11, 2020
Ref
20832BR
Required Education
Bachelors Degree
Position Type
Contract
As a Temp - Clinical Study Lead (CSL) for Phase IV Non-Interventional Studies, you will lead the cross-functional study team responsible for the global execution of Non-Interventional, Observational company sponsored clinical trials (e.g., Registries, post-authorization safety studies (PASS), PMR, DUS, evaluation of REMS and risk minimization measures, regulatory agency required non-interventional efficacy studies (e.g. PAES)). 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 Temp - Clinical Study Lead, 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
• Leading investigator meeting preparation and execution
• Monitoring progress for site activation and monitoring visits and acts on any deviations from plan
• Managing development and implementation of patient recruitment and patient retention strategies
• Monitoring data entry and query resolution and taking action on any divergence from agreed metrics
• Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Raising issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other partners and developing and implementing appropriate actions to address issues
• Ensuring data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required
• Supervising study close-out activities and contributing to clinical study report writing and review
• May include direct supervision of CTM staff including assigning work, performance management, recruitment, coaching and professional development.

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 have significant experience in executing Non-Interventional company sponsored 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 Bachelors' degree with a minimum of 6 years of relevant industry experience. Advanced degrees may be considered in lieu of 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 with trial management software and MS applications to be considered.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.