Senior Manager Clinical Study Lead (Clinical Experimental Sciences)

About the role

The Senior Clinical Study Lead (CSL) Clinical Experimental Sciences Operations (CES Ops) is accountable for the execution of assigned clinical studies/research collaborations from study design, through execution, to study close out. Additionally, there are responsibilities for initiation, oversight and completion of CES Ops continuous improvement and Strategic Imperatives workstreams.

Responsibilities

• Leads the cross-functional study team responsible for clinical study/research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• Provides operational input into research plan and/or study protocol development
• Ensures development of study specific documentation such as samples management plans and data management plans are completed on time and in accordance with the study protocol
• Oversees set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc.
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors, if appropriate
• Provides input into baseline timeline development and management
• Provides input into baseline budget development and management, facilitates internal review of the study budget for assessment of Fair Market Value
• Ensures accurate budget management and scope changes for internal and external studies
• 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 and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
• Manages and oversees study close-out activities
• Ensures End of Study Summary is delivered and properly archived
• Facilitates and contributes to study level lessons learned
• Sets up and manages tasks for Clinical Study Management staff and supports their deliverables
• Recommends and participates in cross-functional and departmental process improvement initiatives
• Works with Therapeutic Focus Area groups within Basic Research/Discovery
• Works closely with clinical site staff, predominantly at academic institutions
• May be 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

Requirements

• A minimum of a Bachelor's degree and 8+ years of relevant clinical experience is required

Qualifications

• Proven experience in clinical study execution
• Strong project management and organizational skills
• Excellent communication and interpersonal skills
• Ability to manage multiple projects simultaneously
• Experience working with clinical sites and academic institutions
• Knowledge of regulatory guidelines and standards (ICH/GCP)
• Experience with clinical trial management systems (CTMS) and Trial Master Files (TMF)

Skills

• Strong leadership and supervisory skills
• Excellent problem-solving and decision-making abilities
• Ability to work independently and as part of a team
• Strong attention to detail and accuracy
• Ability to manage budgets and timelines effectively
• Strong written and verbal communication skills

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$150,500.00 - $245,500.00 annually

Schedule

Onsite in one of our US office locations