Manager, Clinical Study Lead
About The Position
The Manager, Clinical Study Lead is accountable, with moderate oversight, for the global execution of assigned smaller or less complex clinical trials from study design through execution and closeout. The role owns study timelines and budget and ensures study conduct complies with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. Responsibilities may involve internally sourced studies and studies outsourced to Clinical Research Organizations (CROs), with the balance of direct leadership and oversight varying accordingly. The role also contributes to and drives process improvement initiatives. The position leads cross-functional study teams and provides operational leadership across protocol development, feasibility, site selection, study documentation and systems, vendor management, budget and timeline oversight, risk mitigation, recruitment and retention, data review, and study closeout. It assigns work to Clinical Study Management staff and directly supervises CTM staff, including performance management, recruitment, professional development, coaching, mentoring, training, compliance, and study oversight. The role may also perform unmasked study tasks. The position is based in Armonk, NY; Warren, NJ; or Cambridge, MA. Travel of up to 25% may be required. Many Regeneron roles are required to be performed onsite; applicants should discuss role- and location-specific expectations with the recruiter and hiring manager.
Requirements
- Bachelor’s degree.
- At least six years of relevant industry experience.
- Extensive budget management expertise.
- Proven ability to build productive study teams and collaborations.
- Demonstrated vendor management experience.
- Strong technical proficiency with trial management systems and Microsoft applications, including Project, PowerPoint, Word, and Excel, as well as platforms such as IVRS/IWRS and EDC.
- Experience in global clinical trial operations, including developing protocols and key study documents.
- Solid knowledge of ICH/GCP and relevant regulatory guidelines and directives.
- Effective project management, cross-functional team leadership, and organizational skills.
- Ability to understand and implement operational strategic direction and guidance for assigned clinical studies.
Responsibilities
- Lead cross-functional study teams and serve as the primary point of contact for leadership and oversight of clinical study delivery.
- Oversee study execution against planned timelines, deliverables, and budget; raise conduct, quality, timeline, and budget issues to the Program Operations Lead and stakeholders; and implement corrective actions.
- Provide operational input into protocol development, lead feasibility assessments to select regions and countries, oversee or conduct site evaluation and selection, and lead investigator meeting preparation and execution.
- Oversee and contribute to study documentation, including case report forms, data management plans, monitoring plans, monitoring oversight plans, project-specific training plans, data review plans, statistical analysis plans, and related materials.
- Oversee setup and maintenance of study systems, such as CTMS and TMF, and ensure compliance with clinical trial registry requirements.
- Identify outsourcing needs and lead vendor engagement, contracting, and management; ensure CROs and third-party vendors are aligned and deliver according to their scope of work.
- Contribute to baseline budget and timeline development and management; ensure accurate budget management and scope change control for internal and external studies.
- Lead study-level risk assessment and mitigation; monitor site activation and monitoring visits, and act on deviations.
- Lead development and oversee implementation of patient recruitment and retention strategies, respond to deviations from plan, and monitor data entry and query resolution against agreed metrics.
- Manage study closeout, including database lock, vendor contract and budget reconciliation, TMF reconciliation, and study drug accountability.
- Contribute to clinical study report writing and review and facilitate study-level lessons learned.
- Assign tasks to Clinical Study Management staff and support their deliverables.
- Directly supervise CTM staff, including work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support and oversight.
- Recommend and participate in cross-functional and departmental process improvements; identify globally informed approaches to study execution and continuous improvement of CTM SOPs.
- Perform assigned unmasked study tasks, which may include assisting with masked investigational product, setting up and managing an unmasked TMF, reviewing unmasked data in EDC, serving as a point of contact for IVRS issues, and supporting oversight of unmasked clinical monitoring.
Benefits
- Annual bonuses or other incentive plans may be included, depending on country and role.
- Equity awards may be included, depending on country and role.
- Pension or retirement benefits may be included, depending on country and role.
- 401(k) company match.
- Health and wellness programs.
- Fitness centers.
- Insurance benefits, including medical, dental, vision, life, and disability insurance.
- Paid time off.
- Family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
