Stellenbeschreibung
The Clinical Study Lead (CSL) may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. The 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.
As a Manager, Clinical Study Lead, a typical day may include the following:
Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while escalating issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective actions
Provides operational input into protocol development; leads feasibility assessments to select relevant regions and countries; oversees or conducts site evaluation and selection; and leads investigator meeting preparation and execution
Oversees and contributes to study documentation, including case report forms, data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan, and related materials
Oversees set-up and maintenance of study systems (e.g., CTMS, TMF) and ensures compliance with clinical trial registry requirements
Identifies outsourcing needs and leads vendor engagement, contracting, and management; ensures CROs and third-party vendors are aligned and delivering per scope of work
Provides input into baseline budget and timeline development and management; ensures accurate budget management and scope change control for internal and external studies
Leads study-level risk assessment and mitigation; monitors site activation and monitoring visits and acts on deviations; leads development and oversees implementation of patient recruitment and retention strategies and responds to deviations from plan; and monitors data entry and query resolution against agreed metrics
Oversees study drug and clinical supplies forecasting, drug accountability, and reconciliation.
Oversees data quality, including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
Ensures audit and inspection readiness throughout the study; supports internal audits and external inspections and contributes to CAPAs as required
Manages study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability; contributes to clinical study report writing and review; and facilitates study-level lessons learned
Assigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommends and participates in cross-functional and departmental process improvements; and identifies innovative, globally informed approaches to study execution 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
May require up to 25% travel
This role may be for you if:
Demonstrated interpersonal & leadership skills
Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
A data driven approach to planning, executing, and problem solving
Effective 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 key stakeholders
To be considered for this role, candidates must hold a Bachelor’s degree and have at least six years of relevant industry experience. We seek extensive budget management expertise; a proven ability to build productive study teams and collaborations; and demonstrated vendor management experience. Strong technical proficiency with trial management systems and Microsoft applications is required, including Project, PowerPoint, Word, Excel, and platforms such as IVRS/IWRS and EDC. The role also requires experience in global clinical trial operations, including developing protocols and key study documents; solid knowledge of ICH/GCP and relevant regulatory guidelines and directives; and effective project management, cross-functional team leadership, and organizational skills.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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)