Associate Manager 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 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 might include the following:
- Planning and running a clinical study in an assigned region(s) in alignment with the global study plans
- Contributing to risk assessment and helping to identify risk mitigation strategies
- Supporting feasibility assessment to select relevant regions and countries
- Supervising and giving input to the development of study specific documentation e.g. case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc
- Reviewing site level informed consents and other patient-facing study start-up materials
- Playing a lead in the setting up and maintenance of study systems such as Clinical Trial Management System (CTMS) and Trial Master File (TMF)
- Contributing to investigator meeting preparation and execution
- Leading engagement, contracting and supervision of required vendors for the study
- Providing regular status reports to team members as requested by the CSL
- Contributing to development and implementation of recruitment and retention strategies, and monitoring these accordingly
- Supporting data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites
- Escalating data flow and/or quality issues, and any timeline or budget issues to the CSL
- Participating in clinical project audit and inspection readiness throughout the study lifecycle, and assisting with CAPAs as required
- Managing aspects of study close-out activities such as database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability
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 5+ years’ 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. Up to 25% travel may be required.
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 amazing benefits including health and wellness programs, fitness centers and stock 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.