Associate Manager Clinical Study
3 weeks ago
This 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 Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies out
- sourced to Clinical Research Organizations (CROs) and the balance of direct execution versus oversight of CROs deliverables will vary accordingly. The Assoc Mgr Clinical Study works with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron Standard Operating Procedures (SOPs). Travel to study sites may be required to assist with monitoring clinical studies.
**A typical day as a CSAM looks like**:
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 This role may be for you if:
You are an excellent communicator with strong interpersonal skills, and capacity to establish relationships internally and externally
You have a data driven approach to executing and problem solving
You have a good attention to detail to deliver on specific study activities
You are proactive and self-disciplined, and an ability to meet deadlines with an effective use of time
You have budget awareness with the ability to get involved in various aspects of budget management
Up to 25% travel may be required.
Salary Range (annually) $106,200.00 - $173,200.00
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