The Senior Clinical Study Lead (CSL) is expected to operate with 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 close out.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 out-sourced 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 is not eligible fully remote. This role requires 4-days onsite in one of our US locations.
A typical day in this role looks like:
1. Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
2. Provides operational input into protocol development
3. 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.
4. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
5. Ensures compliance with the clinical trial registry requirements
6. Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
7. Provides input into baseline budget development and management
8. Provides input into baseline timeline development and management
9. Leads risk assessment and identifies risk mitigation strategies at the study level
10. Leads the feasibility assessment to select relevant regions and countries for the study
11. Oversees/conducts site evaluation and selection
12. Leads investigator meeting preparation and execution
13. Monitors progress for site activation and monitoring visits and acts on any deviations from plan
14. Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
15. Monitors data entry and query resolution and acts on any deviations from agreed metrics
16. Ensures accurate budget management and scope changes for internal and external studies
17. Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
18. 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
19. Oversees the execution of the clinical study against planned timelines, deliverables and budget
20. Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
21. Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
22. Ensure clinical project audit and inspection readiness through the study lifecycle
23. Supports internal audit and external inspection activities and contributes to CAPAs as required
24. Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
25. Contributes to clinical study report writing and review
26. Facilitates and contributes to study level lessons learned
27. Assigns tasks to Clinical Study Management staff and supports their deliverables
28. Recommends and participates in cross-functional and departmental process improvement initiatives
29. Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
30. 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
31. 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
32. May require 25% travel
This role may be for you if you have:
33. Exceptional interpersonal & leadership skills
34. Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
35. Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving
36. Advanced communication skills via verbal, written and presentation abilities
37. Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
38. Ability to influence and negotiate across a wide range of stakeholders
39. Strong budget management experience
40. An awareness of relevant industry trends
41. Ability to build, lead and develop productive study teams and collaborations
42. Applies advanced negotiation and interpersonal skills to vendor management
43. Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
44. Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
45. Knowledge of ICH/GCP and regulatory guidelines/directives
46. Advanced project management skills, cross-functional team leadership and organizational skills
47. Line management experience
In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience.