- May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study.
- Contributes to risk assessment and helps identify risk mitigation strategies.
- Supports feasibility assessment to select relevant regions and countries.
- Oversees and provides input to the development of study specific documentation including but not limited to: case report form (
CRF), data management plan, monitoring plan, monitoring oversight plan, etc. - Reviews site level informed consents and other patient-facing study start-up materials.
- Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution.
- Oversees engagement, contracting and management of required vendors for the study.
- Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation.
- Provides regular status reports to stakeholders as requested by the Clinical Study Lead.
- Contributes to development of and oversees implementation of recruitment and retention strategies.
- Monitors recruitment and retention.
- 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.
- 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.
- Supports accurate budget management and scope changes.
- Contributes to clinical project audit and inspection readiness throughout the study lifecycle.
- Supports internal and external inspection activities and contributes to CAPAs as required.
- Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability.
- May be responsible for mentoring clinical trial management staff.
- May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring.
-
Manager, Clinical Study Lead
2 weeks ago
Regeneron Pharmaceuticals, Inc Armonk, United States Full timeAs a Clinical Study Lead (CSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studies outsourced t ...
-
Manager, Clinical Study Lead
2 weeks ago
BioSpace Armonk, United StatesJob Details · As a Clinical Study Lead (CSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studie ...
-
Manager, Clinical Study Lead
2 weeks ago
Regeneron Pharmaceuticals Armonk, United StatesRegeneron Pharmaceuticals · Manager, Clinical Study Lead · Armonk , · New York · Apply Now · As a Clinical Study Lead (CSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study c ...
-
Sr. Manager Clinical Study Lead
2 weeks ago
Regeneron Pharmaceuticals Armonk, United StatesThe · Senior Clinical Study Lead · (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable ...
-
Assoc Mgr Clinical Study
2 weeks ago
Regeneron Pharmaceuticals Armonk, United StatesThis role is a hybrid position which means the individual must work on-site 3 days per week. Fully remote work is not possible for this role. The position can be based in Armonk, NY or Basking Ridge, NJ. · A Clinical Study Associate Manager (CSAM) role supports the Clinical Study ...
-
Associate Manager Clinical Study
3 weeks ago
Regeneron Pharmaceuticals Inc. Armonk, United StatesThis role is a hybrid position which means the individual must work on-site 3 days per week. Fully remote work is not possible for this role. The position can be based in Armonk, NY, Basking Ridge, NJ or Uxbridge, England. · The Assoc Mgr Clinical Study (CSAM) role supports the C ...
-
Sr. Manager Clinical Study Lead
2 weeks ago
Regeneron Pharmaceuticals, Inc. Armonk, United States Full timeThe Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for th ...
-
Clinical Study Manager
3 weeks ago
Stryker Corporation Mahwah, United States**Why join Stryker?** · Stryker is seeking to hire a **Clinical Study Manager** to support Joint Replacement Clinical Trials. This role will be based** hybrid **in Mahwah, New Jersey. · **Who we want** · - ** Dedicated achievers. **People who thrive in a fast-paced environment an ...
-
Regeneron Pharmaceuticals, Inc Armonk, United States Full timeWe are seeking to hire a Senior level Precision Medicine Strategy Lead (PMSL) to oversee the development and execution of biomarker strategies for the burgeoning Oncology Portfolio in Clinical Development at Regeneron. In this highly matrixed role, they will independently design, ...
-
Director, Digital Biomarker Lead
2 weeks ago
BioSpace Armonk, United StatesJob Details · We envision a future where innovative digital biomarker endpoints accelerate the translation of Regenerons breakthrough discoveries to novel treatments that enhance patient lives. As a Digital Biomarker Lead reporting to Head of Digital Health Technologies you will ...
-
Senior Manager, Quality Management Lead
2 weeks ago
Regeneron Pharmaceuticals, Inc. Armonk, United States Full timeThe Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and leadership for all aspects of quality and compliance. The incumbent will engage with key collaborators, build strategic par ...
-
BioSpace Armonk, United StatesJob Details · We are seeking to hire a Senior level Precision Medicine Strategy Lead (PMSL) to oversee the development and execution of biomarker strategies for the burgeoning Oncology Portfolio in Clinical Development at Regeneron. In this highly matrixed role, they will indepen ...
-
BioSpace Armonk, United StatesJob Details · We are seeking to hire a Precision Medicine Strategy Lead (PMSL) role to oversee the development and execution of biomarker strategies for the exciting Oncology Portfolio in Clinical Development at Regeneron. In this highly matrixed role, they will design, develop, ...
-
Regeneron Pharmaceuticals Armonk, United StatesWe are seeking to hire a Senior level Precision Medicine Strategy Lead (PMSL) to oversee the development and execution of biomarker strategies for the burgeoning Oncology Portfolio in Clinical Development at Regeneron. In this highly matrixed role, they will independently design, ...
-
BioSpace Armonk, United StatesJob Details · The Associate Director, Precision Medicine Strategy Lead will independently oversee the development and execution of biomarker strategies across Oncology/ Immuno-Oncology. They will design, develop, communicate at senior levels and operationally implement Precision ...
-
Regeneron Pharmaceuticals Armonk, United StatesThe Associate Director, Precision Medicine Strategy Lead will independently oversee the development and execution of biomarker strategies across Oncology/ Immuno-Oncology. They will design, develop, communicate at senior levels and operationally implement Precision Medicine strat ...
-
BioSpace Armonk, United StatesJob Details · We are seeking to hire a Senior level Precision Medicine Strategy Lead (PMSL) to oversee the development and execution of biomarker strategies for the burgeoning Oncology Portfolio in Clinical Development at Regeneron. In this highly matrixed role, they will indepen ...
-
Regeneron Pharmaceuticals, Inc. Armonk, United States Full timeThe Precision Medicine group at Regeneron is responsible for designing, implementing, executing, analyzing and interpreting the overarching clinical biomarker strategies for therapeutic candidates during clinical development. We are seeking to hire multiple individuals for Precis ...
-
Senior Manager, Regulatory Intelligence
2 weeks ago
Regeneron Pharmaceuticals, Inc. Armonk, United States Full timeThis role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. This position will also serve as a lead Reg Intel contact in s ...
-
Associate Veterinarian
1 day ago
VCA Mount Kisco, United States Full timeVCA Mount Kisco Veterinary Clinic is seeking an Associate Veterinarian to complement our talented team in Mount Kisco, New York . · Current students or new graduates, apply today · VCA takes pride in expanding the growth and skill set of new veterinarians. We welcome newly gr ...
Associate Manager, Clinical Study - Armonk, NY, United States - Regeneron - Willhire
3 weeks ago
Description
Associate Manager, Clinical StudyBudget
Case Report
Clinical Monitoring
Clinical Study
Clinical Trial
CRF
Database
Data Management
Data Quality
Forecasting
Reconciliation
Trial Management
Description:
Associate Manager, Clinical Study
Pay Range:
$ $72.74/hr
Hybrid Role in Armonk, NY
The Temp Assoc Mgr Clinical Study will be assigned activities by the CSL, including:
Requirements:
Bachelor's degree and at least 5 years of experience.
This is a contract position at Regeneron with Magnit Global being the Employer.
To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion.
As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.
We strive to ensure that we maintain a positive and enriching work environment for all.W2 only, no third party solicitation
QUALIFICATION/ LICENSURE :
Work Authorization :
Green Card, US Citizen
Preferred years of experience : 5+ Years
Travel Required :
No travel required
Shift timings: 9 AM to 5 PM