Manager, Integrated Data Review and Quality

Regeneron Pharmaceuticals; Hyderabad; Hybride; INR 1 800 000 - 2 800 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals in Hyderabad is seeking a Senior Data Manager to lead integrated data review activities across studies, ensuring data quality and timely issue resolution.

You will develop Data Review Plans, guide the Data Review Team, review clinical and safety data, present findings to cross-functional partners, manage study-level queries, and support database readiness and lock with risk-based approaches.

Qualifications

• Bachelor’s degree in Life Sciences, Statistics, CS, or related field.
• 7+ years of direct Clinical Data Management experience.
• 4+ years in Integrated Data Review and data quality management.
• 2+ years of people leadership or cross-functional experience.
• Strong knowledge of ICH guidelines, GxP, and 21 CFR Part 11.
• Willingness to travel up to 25%.

Responsabilités

• Manage Integrated Data Review activities per established standards.
• Develop and execute Data Review Plans for studies; track data quality risks.
• Lead Data Review Team meetings; discuss findings and actions.
• Review clinical, safety, and external data using listings, dashboards, etc.
• Present findings to study teams and stakeholders.
• Manage study-level queries, investigations, and resolutions.
• Support database readiness and lock; ensure timely quality issue closure.
• Apply risk-based approaches to identify critical data risks.
• Act as SME for integrated data review and discrepancy management.
• Support SOPs, templates, training, and process improvements.
• Contribute to analytics, automation, AI-enabled solutions.
• Lead, coach, and develop team; workload planning.

Connaissances

Integrated Data Review

Data Review Plans

Risk-Based Data Management

Data Quality Management

Root-Cause Analysis

Stakeholder Management

Team Leadership

ICH Guidelines

Formation

Bachelor’s degree in Life Sciences, Statistics, Computer Science, or related field

Description du poste

Build our future together:

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for people with serious diseases.

When & where:

Hyderabad (hybrid)

Discover your role:

• Manage Integrated Data Review activities in line with established methodologies, standards, processes, and governance requirements.
• Develop, execute, and be responsible for Data Review Plans for assigned studies, ensuring data quality issues and risks are identified, tracked, escalated, and resolved.
• Lead Data Review Team meetings and facilitate discussions on findings, discrepancies, trends, risks, actions, and issue resolution.
• Review and interpret clinical, operational, safety, and external data using listings, visualizations, dashboards, patient profiles, analytical reports, and discrepancy reports.
• Present data review findings, risks, trends, and recommendations to study teams and cross-functional stakeholders.
• Manage study-level queries and discrepancies, including investigation, documentation, blocking issue, corrective action, resolution, and closure.
• Support database readiness and database lock by ensuring data review activities and quality issues are completed and resolved on time.
• Apply risk-based approaches to identify critical data and quality risks aligned with study objectives and critical-to-quality factors.
• Act as a subject matter expert for Integrated Data Review, Data Review Plans, discrepancy management, risk identification, and data quality issue resolution.
• Support SOPs, work instructions, templates, training materials, guidance, metrics, lessons learned, and process improvements.
• Contribute to initiatives involving analytics, automation, AI-enabled solutions, and integrated review across clinical and external data domains.
• Lead, coach, mentor, and develop team members, and support workload planning, resource allocation, priorities, and study deliverables, as applicable.

This role requires:

• A bachelor’s degree in Life Sciences, Statistics, Computer Science, or a related field.
• At least 7 years of direct Clinical Data Management experience within biotechnology, pharmaceutical, CRO, or healthcare.
• At least 4 years of experience in Integrated Data Review, Data Quality Management, Risk-Based Data Management, or related clinical data review activities.
• At least 2 years of people management, team leadership, or equivalent experience leading study-level or cross-functional initiatives.
• Strong knowledge of clinical data management, integrated data review, data quality management, issue management, and clinical trial data flow.
• Experience developing and executing Data Review Plans and leading Data Review Team meetings.
• Experience reviewing clinical, operational, safety, and external data to identify trends, anomalies, inconsistencies, and quality risks.
• Experience leading study-level queries and discrepancies and driving root-cause analysis, corrective actions, and resolution.
• Solid understanding of Risk-Based Data Management and Risk-Based Quality Management principles.
• Solid understanding of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, global data privacy requirements, and inspection readiness.
• The ability to lead and influence in a matrix organization and build strong partnerships across clinical development functions.
• Strong analytical, strategic, critical-thinking, stakeholder management, facilitation, negotiation, and communication skills.
• The ability to manage multiple studies, priorities, and competing deliverables in a fast-paced environment.
• Willingness to travel up to 25%, when required.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.