Warren, Michigan, United States · Hybrid
$110k–$179k/yr
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Associate Manager to join our Clinical Trial man…
Skills: Clinical Trial Management, Vendor Management, Risk Assessment, Budget Management, ICH/GCP Guidelines
New York, New York, United States · On-site
$115k–$190k/yr
Morgan Stanley is a leading global financial services firm providing a wide range of investment banking, securities, investment management and wealth management services. The Firm's employees serve clients worldwide incl…
Skills: Machine Learning, Deep Learning, Recommender Systems, Natural Language Understanding, Large Language Models
Albany, New York, United States · On-site
$59k–$89k/yr
Department/Unit: Serology/Immunology Work Shift: Day (United States of America) Salary Range: $59,066.00 - $88,599.00 Lab Techs will utilize knowledge and clinical laboratory experience to perform testing in an accurate …
Skills: Clinical Laboratory Testing, Serology, Immunology, Quality Control, Automated Equipment Operation
New York, New York, United States · On-site
$85k–$140k/yr
Morgan Stanley is a leading global financial services firm providing a wide range of investment banking, securities, investment management and wealth management services. The Firm's employees serve clients worldwide incl…
Skills: Machine Learning, Python, C++, Deep Learning, Recommender Systems
New York, New York, United States · On-site
$169k–$210k/yr
We understand that the world we want tomorrow starts with how we do business today, and that’s why we’re inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to…
Skills: Program Management, Project Management, Management Consulting, Strategy Execution, Strategic Planning
New York, New York, United States · On-site
$278k–$425k/yr
About Us: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of al…
Skills: Genitourinary Pathology, Diagnostic Services, Translational Research, Patient Care, Clinical Research
Waterford, New York, United States · On-site
$96k–$140k/yr
Job Title:Process Engineer Summary:The Process Engineer owns production area performance, resolving daily issues, supporting operators, and driving continuous improvements. Responsibilities include achieving targets in E…
Skills: Chemical Engineering, Process Optimization, EHS Compliance, Root Cause Analysis, Six Sigma
Warren, Michigan, United States · Hybrid
$110k–$179k/yr
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Associate Manager to join our Clinical Trial man…
Skills: Clinical Trial Management, Vendor Management, Risk Assessment, Budget Management, ICH/GCP Guidelines
New York, New York, United States · On-site
$74k–$124k/yr
PURPOSE AND SCOPE: Provides nutritional services for the facility’s in-center and home patients as applicable in order to maximize the patient’s nutritional status and improve clinical outcomes. Functions as a member of …
Skills: Clinical Nutrition, Patient Education, Nutritional Assessment, Renal Nutrition, Care Plan Development
Rochester, New York, United States · On-site
$21/hr–$30/hr
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. …
Skills: Data Entry, Case Report Forms, Regulatory Compliance, Data Analysis, Quality Assurance
Rome, New York, United States · On-site
$17/hr–$21/hr
Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improv…
Skills: Venipuncture, Capillary Techniques, Specimen Collection, Data Entry, Billing Processing
New York, New York, United States · On-site
$260k–$425k/yr
About Us: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of al…
Skills: Immunohematology, Transfusion Service Operations, Apheresis, Cell Therapy, Blood Banking
City of Ithaca, New York, United States · On-site
$85k–$100k/yr
Job DetailsJob Location: 730 Warren Rd - Ithaca, NY 14850Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $85,000.00 - $100,000.00 Salary/yearTravel Percentage: NoneJob Category: Admin - ClericalPositi…
Skills: Laboratory Management, Staff Supervision, Workflow Coordination, LIMS, Quality Assurance
Albany, New York, United States · On-site
$108k–$149k/yr
Who We Are Applied Materials is a global leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. We design, build and service cutting-edge equipment that help…
Skills: Process Integration, Semiconductor Fabrication, Photonic Devices, Yield Analysis, Statistical Process Control
New York, New York, United States · On-site
$25/hr–$35/hr
Work Flexibility: Field-based As an Endoscopy OnSite Specialist, you will play an essential role in supporting surgical teams and ensuring that equipment, processes, and information flow smoothly to help drive exceptiona…
Skills: Surgical Equipment Management, Clinical Support, Troubleshooting, Sterile Processing, Patient Care
Town of Amherst, New York, United States · On-site
Daemen University is a dynamic, independent, liberal arts institution committed to excellence in student centered learning. The University places special emphasis on preparing students for excellence in professional life…
Skills: Undergraduate Teaching, Psychology of Mental Illness, Curriculum Delivery, DSM Knowledge, Student Instruction
New York, New York, United States · Remote OK
$220k–$230k/yr
The Director, Clinical Operations is responsible for oversight and conduct of LB’s Major Depressive Disorder (MDD) clinical program to ensure completion per established project team goals and objectives. The Director wil…
Skills: Clinical Operations Management, CNS Indication Experience, CRO Oversight, GCP/ICH Guidelines, Phase II-IV Clinical Trials
Albany, New York, United States · On-site
$59k–$89k/yr
Department/Unit: Microbiology Work Shift: Evening (United States of America) Salary Range: $59,066.00 - $88,599.00 Lab Info Tech: The Laboratory Information Technologist (LIT) receives specimens and verifies identificati…
Skills: Laboratory Information Systems, Specimen Processing, Data Entry, Patient Confidentiality, IATA Guidelines
Hauppauge, New York, United States · On-site
$68k–$136k/yr
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnost…
Skills: Cardiac Rhythm Management, Electro-physiology, Clinical Support, Relationship Building, Technical Training
Yorktown Heights, New York, United States · Hybrid
$102k–$164k/yr
\n We offer Psychologists: Flexible hybrid system, in person and remote. Generous ‘above market’ compensation with unlimited/uncapped earnings. Full benefits package W2: health, dental, vision, life, 401k (with match), p…
Skills: Clinical Psychology, Patient Care, Psychological Assessment, Therapy, Clinical Credentialing
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The role involves overseeing the planning and management of clinical studies, including risk assessment, vendor management, and the development of study-specific documentation. The manager is responsible for monitoring recruitment, ensuring data quality, and managing study close-out activities such as database locks and budget reconciliation.
Candidates must have a Bachelor's degree and at least 4 years of relevant industry experience in clinical trial operations. Proficiency in trial management systems, knowledge of ICH/GCP guidelines, and strong interpersonal communication skills are required.
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Associate Manager to join our Clinical Trial management team. In this role, you will support the Clinical Study Lead by taking responsibility for areas of clinical trial delivery, applying to both internally sourced studies and studies out-sourced to CROs, while collaborating with the study team internally and externally with vendors such as CROs.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Location: Armonk, NY, Warren, NJ
Travel percentage: May require 25% travel
May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with global study plans, and may contribute to global planning and management of the study
Contributes to risk assessment and helps identify risk mitigation strategies, and supports feasibility assessment to select relevant regions and countries
Oversees and provides input to the development of study specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan) and reviews site level informed consents and other patient-facing study start-up materials
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution
Oversees engagement, contracting and management of required vendors for the study, and oversees and provides input to study drug and clinical supplies' forecasting, drug accountability and drug reconciliation
Provides regular status reports to collaborators as requested by the Clinical Study Lead, and contributes to development of and oversees implementation of recruitment and retention strategies
Monitors recruitment and retention, and monitors progress for site activation and monitoring visits
Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites, and escalates data flow and data quality issues to Clinical Study Lead
Oversees the execution of the specific clinical study deliverables against planned timelines, escalates issues related to timelines or budget to Clinical Study Lead, and supports accurate budget management and scope changes
Contributes to clinical project audit and inspection readiness throughout the study lifecycle, and supports internal and external inspection activities and contributes to CAPAs as required
Manages aspects of study close-out activities including database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability, may mentor clinical trial management staff, and may be assigned unmasked tasks for studies (e.g., unmasked TMF management, unmasked data review, IVRS point of contact)
Bachelor's Degree and 4+ years of relevant industry experience
Excellent communication and interpersonal skills; ability to build relationships internally and externally
A data driven approach to executing and problem solving, and attention to details for the ability to deliver on specific study activities
Technical proficiency in trial management systems and MS applications including Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
Budget awareness with the ability to participate in various aspects of budget management
Familiarity with medical terms, and vendor management experience
Experience in clinical trial operations including experience developing key study documents
Knowledge of ICH/GCP and regulatory guidelines/directives
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 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.
Salary Range (annually)
$109,900.00 - $179,300.00At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
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