The Senior Clinical Study Lead (CSL) is expected to operate with a high degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design through execution to study closeout. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives.
This role has a 3-day onsite minimum requirement at either Basking Ridge, NJ, or Armonk, NY. This role is not fully eligible for remote work.
A typical day in this role looks like:
- Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact for leadership and oversight (as required) for the assigned study.
- Provides operational input into protocol development.
- Oversees and provides input to the development of study-specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan, etc.
- Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF), etc.
- Ensures compliance with the clinical trial registry requirements.
- Identifies outsourcing needs of the study and leads and oversees engagement, contracting, and management of required vendors.
- Provides input into baseline budget development and management.
- Provides input into baseline timeline development and management.
- Leads risk assessment and identifies risk mitigation strategies at the study level.
- Leads the feasibility assessment to select relevant regions and countries for the study.
- Oversees/conducts site evaluation and selection.
- Leads investigator meeting preparation and execution.
- Monitors progress for site activation and monitoring visits and acts on any deviations from the plan.
- Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from the plan.
- Monitors data entry and query resolution and acts on any deviations from agreed metrics.
- Ensures accurate budget management and scope changes for internal and external studies.
- Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability, and drug reconciliation.
- Escalates issues related to study conduct, quality, timelines, or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues.
- Oversees the execution of the clinical study against planned timelines, deliverables, and budget.
- Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites.
- Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work.
- Ensure clinical project audit and inspection readiness through the study lifecycle.
- Supports internal audit and external inspection activities and contributes to CAPAs as required.
- Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability.
- Contributes to clinical study report writing and review.
- Facilitates and contributes to study level lessons learned.
- Assigns tasks to Clinical Study Management staff and supports their deliverables.
- Recommends and participates in cross-functional and departmental process improvement initiatives.
- Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs.
- May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring.
- Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
- May require 25% travel.
This role may be for you if you have:
- Exceptional interpersonal & leadership skills.
- Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies.
- Demonstrates expert knowledge and a data-driven approach to planning, executing, and problem-solving.
- Advanced communication skills via verbal, written, and presentation abilities.
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization.
- Ability to influence and negotiate across a wide range of stakeholders.
- Strong budget management experience.
- An awareness of relevant industry trends.
- Ability to build, lead, and develop productive study teams and collaborations.
- Applies advanced negotiation and interpersonal skills to vendor management.
- Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC.
- Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
- Advanced project management skills, cross-functional team leadership, and organizational skills.
- Line management experience.
In order to be considered qualified for this role, you must possess a Bachelor’s degree with a minimum of 8 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 in trial management software and MS applications to be considered.
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): $145,400.00 - $237,200.00
#J-18808-Ljbffr
