The Clinical Study Associate Manager (CSAM) role supports the Clinical Study Lead 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. You 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 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 collaborators 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
Brings up data flow and data quality issues to Clinical Study Lead
Oversees the execution of the specific clinical study deliverables against planned timelines
Brings up 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
May require 25% travel
This role may be fore you if you have:
Experience in Hematology or Oncology studies is preferred
Prior global trial experience
Experience collaborating with multiple key collaborators
A passion for science
Phenomenal organizational skills
In order to be considered qualified for this role , a minimum of a Bachelors degree is required with 3-5 years of relevant experience in a clinical setting preferred.Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually)$106,200.00 - $173,200.00