Senior Clinical Study Lead (Real World Evidence)

Location
Multiple locations
Posted
Mar 20, 2018
Ref
10889BR
Required Education
Masters Degree/MBA
Position Type
Full time
This job is available in these locations: Tarrytown, NY, US, Dublin, Ireland, London, United Kingdom, Tarrytown, NY, US, Westchester County, NY, US

Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

The Senior Clinical Study Lead (Real World Evidence) (SrCSL (RWE)) is accountable for the global execution of a range of study design types within the "Real-World" setting including both observational research/ non-interventional studies. The SrCSL (RWE) is accountable for study leadership and oversight including study timelines, study budget from design, through execution, to study close out, in accordance with applicable regulations, ICH GCP/ GPP/ GVP and company Standard Operating Procedures (SOPs) applicable to these studies. 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. May have direct line management responsibilities.

Responsibilities:
  • 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
  • Provides operational input into protocol development
  • Oversees and provides input to the development of study specific documentation as applicable per the study setting
  • Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
  • Ensures compliance with the clinical trial registry requirements if applicable
  • Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
  • Provides input into baseline budget development and management
  • Provides input into baseline timeline development and management
  • Leads risk assessment and identifies risk mitigation strategies at the study level
  • Leads the feasibility assessment to select relevant regions and countries for the study
  • Oversees/conducts site evaluation and selection
  • Leads investigator/study coordinator meeting preparation and execution as applicable
  • Monitors progress for site activation and monitoring visits and acts on any deviations from plan as applicable
  • Monitors data entry and query resolution and acts on any deviations from agreed metrics as applicable
  • 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 study against planned timelines, deliverables and budget
  • Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, and suspected serious non-compliance by sites
  • Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
  • Ensure clinical project audit and inspection readiness through the study lifecycle
  • Supports internal audit and external inspection activities and contributes to CAPAs as required
  • Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF
  • Contributes to clinical study report writing and review
  • Facilitates and contributes to study level lessons learned
  • Assigns tasks to Clinical Study Management staff and supports their deliverables
  • Recommends and participates in cross-functional and departmental process improvement initiatives
  • Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs

Job Requirements:
  • Experience in study leadership and management of clinical trials or RWE studies that span the clinical development lifecycle (e.g. Phase 0 and Phase IV/Post-market)
  • Demonstrable understanding of the differences between the interventional and non-interventional study settings and the appropriate use of GCP/ GPP etc.
  • Ability to build strong working partnerships and collaborate, with influencing and negotiation skills as necessary, to develop fit for purpose processes to be applied in the RWE setting.
  • Demonstrated interpersonal & leadership skills
  • Ability to understand and implement the 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
  • Budget management experience
  • An awareness of relevant industry trends
  • Ability to build productive teams and collaborations
  • Demonstrated vendor management experience
  • Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, EDC
  • Experience in global clinical trial operations including experience developing protocols and key study documents
  • Knowledge of ICH GCP/ GPP/ GVP and regulatory guidelines/directives
  • Effective project management skills, cross-functional team leadership and organizational skills
  • Line management experience

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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Requisition Number: 10889BR