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.

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.

Responsibilities:

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

Requirements:

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

Medical Director(s)

Health Economics & Outcomes Research

Project Management

Data Management, Biostatistics

Procurement

Clinical Finance

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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