Clinical Study Associate Manager (CSAM)

Warren, OH - USA

Monthly Salary: $ 109900 - 179300

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

The Associate Manager Clinical Study (CSAM) role supports the Clinical Study Lead (CSL) by takingresponsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct execution versus oversight ofCROs deliverables will vary accordingly. The Assoc Mgr Clinical Study works with the study team internallyand externally with vendors such as CROs in feasibility planning initiation maintenance and closeout ofclinical projects according to GCP ICH CFR and Regeneron Standard Operating Procedures (SOPs). Travel tostudy sites may be required to assist with monitoring clinical studies.

A typical day in this role looks like:

May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignmentwith 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 notlimited to: case report form (CRF) data management plan monitoring plan monitoring oversight planetc.
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 TrialManagement System (CTMS) and Trial Master File (TMF) Contributes to investigator meetingpreparation 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 anddrug 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 withmasked investigational product set up and management of unmasked trial master file review ofunmasked data in the electronic data capture system point of contact for IVRS issues and supportoversight of unmasked clinical monitoring

In order to be considered qualified for this role a minimum of Bachelors degree and 4 years of relevant clinical trial expereince is required.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

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 nationality national or ethnic origin civil status age citizenship status membership of the Traveler community sexual orientation disability genetic information familial status marital or registered civil partnership status pregnancy or parental status gender identity gender reassignment military or veteran status or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.

Salary Range (annually)

$109900.00 - $179300.00

Required Experience:

Manager

The Associate Manager Clinical Study (CSAM) role supports the Clinical Study Lead (CSL) by takingresponsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct execution v...

A typical day in this role looks like:

May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignmentwith 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 notlimited to: case report form (CRF) data management plan monitoring plan monitoring oversight planetc.
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 TrialManagement System (CTMS) and Trial Master File (TMF) Contributes to investigator meetingpreparation 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 anddrug 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 withmasked investigational product set up and management of unmasked trial master file review ofunmasked data in the electronic data capture system point of contact for IVRS issues and supportoversight of unmasked clinical monitoring