Clinical Study Associate Manager

Location
Tarrytown, New York
Posted
Mar 20, 2018
Ref
11464BR
Required Education
Associate Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

The Clinical Study Associate Manager role supports the Clinical Study Leader 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 monitoring clinical studies.

Responsibilities:

The Clinical Study Associate Manager will be assigned activities by the CSL, including:
• 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 Leader
• 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 Leader
• Oversees the execution of the specific clinical study deliverables against planned timelines
• Escalates issues related to timelines or budget to Clinical Study Leader
• 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

Requirements:

Minimum Years of Experience:

Bachelor's degree and a minimum of 4+ years' industry related work experience or an advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work preferred.

• 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

Key Team Membership (including, but not limited to):
• Clinical Study Team

Cross Functional Interfaces (including, but not limited to):
• Project Management
• Data Management, Biostatistics
• Medical Director(s)
• Procurement
• Clinical Finance

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 11464BR