Clinical Study Associate Manager

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.

A Clinical Study Associate Manager (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 outsourced to Clinical Research Organizations (CROs). The balance of direct execution versus oversight of CROs deliverables will vary accordingly. The individual will work 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 CSAM looks like:

• 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

To be considered for this role you must have a Bachelor’s degree and 4+ years’ pharmaceutical industry related work experience. Less experience with an advanced degree may be considered. We must have candidates who have vendor management experience, as well as experience in clinical trial operations including developing key study documents. We also require someone who has technical proficiency in trial management systems, Microsoft applications and TMF, as well as familiarity with medical terms, and a knowledge of Good Clinical Practice and regulatory guidelines.