Temp - Senior Manager, Clinical Outcomes Assessment (COA) - Tarrytown
Employment Type: Full-Time
Industry: Scientific Research
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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.
The Senior Clinical Outcomes Assessment (COA) Manager (COM) is accountable for electronic COA (eCOA) in individual clinical research studies from study design to close out in collaboration with the study team. The COM is accountable for the eCOA project timelines, translation, eCOA study specifications, executing UAT, and ensuring collection of eCOA 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 of eCOA will vary accordingly. Responsible for creating and enforcing eCOA systems standards, managing vendor performance, and supporting training & education of stakeholders. May participate and lead process improvement initiatives in global development. This role may be responsible for line management of staff including recruitment, retention, professional development, training, mentoring, and performance management.
Responsible & accountable for the successful delivery of eCOA for one or more clinical research trials with quality and compliance
Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle
Applies eCOA systems expertise on day-to-day activities when issues are escalated
Communicates with internal and external stakeholders and escalates risks
Provides input into protocol development as it relates to clinical outcomes
May participate in creation of eCOA standards
Define and support strategy for eCOA migration and COA validation
Support Clinical Study Lead with license acquisition
Responsible for eCOA and translation vendor selection, in collaboration with study team
Oversee eCOA vendor performance at the clinical trial level, including oversight of KPI, performing root cause analysis and identifying corrective actions, and serving as point of escalation for eCOA issues.
Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to COA:
o Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all eCOA systems related issues and end of study vendor deliverables
o Risk management planning
o Communication planning, information distribution, performance reporting, and project closure.
Provides support for problem resolution between eCOA vendors and Regeneron study team
Monitor financial components related to COA and Innovation for each study
Collaborate with study team members on medical monitoring plan
Collaborate with data management on eCOA data specifications, standards, and transfers
Provides training and mentor new staff
Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations
Develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
Communicates clinical innovations in eSource modalities to stakeholders and broader organization
Develops strategy for implementation of innovative clinical trial technologies and disruptive innovations
Provide consultation on eCOA modality benefits, risks, costs and process
Facilitates and contributes to study level lessons learned
Recommends and participates in cross-functional and departmental process improvement initiatives
Responsible for direct supervision of staff
May require up to 25% travel
Bachelor's degree and minimum of 5 years relevant industry experience.
Demonstrate knowledge of eCOA systems development processes
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
Ability independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to Regeneron and external vendors
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Ability to influence and negotiate
An awareness of relevant industry trends
Demonstrated vendor management experience
Technical proficiency in trial management systems and Microsoft Project Server
Knowledge of ICH/GCP and regulatory guidelines/directives
Effective project management skills, cross-functional team leadership and organizational skills
Key Team Membership (including, but not limited to):
Clinical Study Team
Clinical Operations Review Meeting(s)
Clinical Compliance Meeting(s)
Cross Functional Interfaces (including, but not limited to):
Clinical Study Leader
Health Economics & Outcomes Research
Data Management, Biostatistics
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.
Associated topics: antibody, biopharmaceutical, diet, dietary, food scientist, histotechnologist, industrial hygienist, microbiological, pharmacy, therapeutic
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