BioSpace
Website:
biospace.com
Job details:
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 those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Central Monitoring, Data Analysis to join our Global Clinical Trial Services team. In this role, you will oversee centralized monitoring activities for global and complex clinical trials and support the configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) platforms. You will leverage your programming and analytical expertise to create customized analyses, automate workflows, integrate data systems, and deliver actionable insights that support informed decision-making and optimize clinical trial performance. You may also oversee multiple studies within an assigned therapeutic area, lead process-improvement initiatives, and collaborate with cross-functional teams and industry partners to advance central monitoring capabilities.
When & Where
Hyderabad, India (hybrid)
Discover Your Role
- Act as a subject-matter expert for the configuration, implementation, and execution of Central Monitoring RBQM platforms across studies.
- Maintain Regeneron Central Monitoring Key Risk Indicator and Quality Tolerance Limit libraries to ensure consistent deployment across studies and alignment with regulatory requirements.
- Configure studies within an RBQM platform by partnering with functional and cross-functional stakeholders to develop Central Monitoring configuration specifications.
- Provide operational expertise, training, and guidance, serving as an escalation point for issues related to the Central Monitoring RBQM platform.
- Conduct central monitoring reviews as required, including recurring data refreshes and troubleshooting execution errors in support of Study Central Monitors.
- Apply programming expertise to support Central Monitoring data analysis, automation, reporting, and system integration.
- Interpret and present Key Risk Indicator and Key Performance Indicator data to support informed decision-making.
- Contribute to the continuous improvement and standardization of technologies, systems, processes, and training materials that support Central Monitoring and RBQM.
- Represent Central Monitoring in process-improvement initiatives and collaborate effectively with internal and external stakeholders.
- Oversee multiple studies within an assigned therapeutic area, as applicable, and contribute to innovation in central monitoring capabilities.
- Travel up to 25%, as required.
This Role Requires
- At least 7 years of relevant biotechnology or pharmaceutical industry experience. Experience in Central Monitoring, site monitoring, or data management is preferred.
- A minimum of 2 years of direct experience with RBQM systems.
- Technical expertise in database design, system configuration, and report development, with experience managing RBQM or similar platforms.
- Proficiency in programming languages such as Python, R, SQL, or SAS, with the ability to develop scripts for data analysis, automation, and system integration.
- Strong analytical, critical-thinking, and problem-solving skills, including experience troubleshooting data refreshes and resolving execution errors in analytical systems.
- Working knowledge of the clinical drug-development process, including ICH and GCP guidelines and applicable regulatory requirements.
- Experience with clinical databases, electronic data-capture systems, quality-control processes, and auditing procedures.
- The skills for mathematical concepts, statistical methodologies, and data analytics, with the ability to interpret KRIs and KPIs.
- The ability to identify and interpret current and emerging business trends and apply them to centralized monitoring practices.
- Effective interpersonal, verbal, and written communication skills, with the ability to convey sophisticated technical and analytical insights clearly and concisely.
- The ability to collaborate across cross-functional teams and build effective internal and external relationships.
- Proficiency in Microsoft Office applications, including sophisticated Excel skills for data manipulation and reporting.
- Experience using CluePoints or a similar centralized monitoring and risk-based quality management solution is preferred
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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. If you have any questions, please speak with your recruiter.
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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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.
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