Senior Mgr Clinical Study Lead (CSL) Job Description
Accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.
The Senior Manager is accountable for study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
Key Responsibilities:
* Led the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight 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, etc.
Ensure compliance with clinical trial registry requirements, identify outsourcing needs of the study and lead and oversee engagement, contracting and management of required vendors.
Provide input into baseline budget development and management, leads risk assessment and identifies risk mitigation strategies at the study level, monitors progress for site activation and monitoring visits and acts on any deviations from plan.
Develops and oversees implementation of patient recruitment and retention strategies, ensures accurate budget management and scope changes for internal and external studies.
Manages and oversees study close-out activities, contributes to clinical study report writing and review, and facilitates and contributes to study level lessons learned.
This role requires direct supervision of CTM staff and 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. 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 Project, Power Point, Word, Excel, IVRS/IWRS, EDC.
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.
You will also need technical proficiency in trial management software and MS applications to be considered.