Temp - Senior Manager, Clinical Outcome Assessment (COA)

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 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.

Job Duties:

• 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

• Risk management planning

• 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

Requirements:

• 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

• Medical Director(s)

• Health Economics & Outcomes Research

• Project Management

• Data Management, Biostatistics

• Procurement

• Clinical Finance

Bachelor's degree and minimum of 5 years relevant industry 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.