Temp - Assoc Mgr Clinical Study (Early Development)

The Clinical Study Associate Manager 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.  The Clinical Study Associate Manager 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 supervising clinical studies.

JOB DUTIES:  

•  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 Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution

• Is responsible for 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 customers as requested by the Clinical Study Lead

• Contributes to development of and is responsible for implementation of recruitment and retention strategies

• 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

• Leads 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

JOB REQUIREMENTS:

• Excellent communication and interpersonal skills; ability to build relationships internally and externally

• A data driven approach to executing and problem solving

• Attention to details for the ability to deliver on specific study activities

• Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF

• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

• Budget awareness with the ability to participate in various aspects of budget management

• Familiarity with medical terms

• Vendor management experience

• Experience in clinical trial operations including experience developing key study documents

• Knowledge of ICH/GCP and regulatory guidelines/directives

Minimal requirements:

• Bachelors Degree

• 4+ years of relevant industry experience.

To be considered for this opportunity you must possess a Bachelors’ degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered.

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 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 maternity 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.