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 Risk and Strategic Monitoring Lead is responsible for the development, execution and oversight of study risk-based monitoring strategies.
The role sits in Global Monitoring and reports into the Head of Strategic Monitoring.
The incumbent will collaborate with Clinical Trial Management study teams to design fit-for-purpose monitoring specifications, review CRO bids and strategy proposals, act as operational lead for study risk assessment (QRACT) process, and derive the final study risk-based monitoring strategy and associated costs for studies conducted in Global Clinical Operations.
In addition, the role will be responsible for developing study-specific critical data TSDV specifications, ensuring critical data SDR approaches, completing monitoring plan reviews, and acting as an RBQM subject matter expert to both internal and external stakeholder groups.
The incumbent will also play a key role in process improvement, innovation initiatives and industry collaboration(s) The Strategic Monitoring Snr Manager will collaborate closely with Clinical Trial Management, Central Oversight Monitoring, GCP Quality, Strategic Sourcing and Procurement and Business Operations.
Responsibilities:
• Attends Expanded Synopsis (ES) planning and design meetings as a Strategic Monitoring subject matter expert to provide relevant input on initial protocol de-risking and the proposed monitoring strategy
• Facilitates the Quality and Risk Assessment process leveraging cross functional input to complete the study specific QRACT after Expanded Synopsis approval
• Creates a study specific monitoring strategy which includes, but is not only limited to the identification of critical data and process, consulting on data review methods (including Key Risk Indicators and appropriate detection approaches) and the study specific monitoring visit strategy
• Provides monitoring functional expertise to support study budget planning and approval as well as subsequent change orders and ongoing study budget assessments
• Ensures translation of derived monitoring strategy into Clinical Monitoring Plan and shares with CRO partners and/or Regeneron clinical study teams
• Creates tSDV specifications in collaboration with CROs and data management
• Oversees the day to day execution of the monitoring strategy by CRO Partners and/or Regeneron clinical study teams
• Participates in Clinical Study Team Meetings and Quality Review Meetings providing input to study teams on existing and emergent operational risk
• Responsible for regular review, documentation and follow up of risk assessment including revision of monitoring strategy if applicable
• Supports inspection readiness activities and participates in Regulatory GCP inspections and/or audits
• Contributes to process improvement initiatives
• Presents findings, provides trending and status reports to senior management Requirements:
• Bachelors Degree as a minimun and 8 years relevant industry and/or CRO experience.
• Experience of working in a risk based quality operating model
• Extensive experience in global clinical trial operations required
• Extensive medical and scientific knowledge and clinical development understanding
• Excellent interpersonal skills and demonstrated collaborative as well as independent working style
• Ability to build relationships with internal stakeholders
• Ability to translate a design strategy into an operating framework
• Critical thinker
• Proactive and self-motivated
• Strong organizational skills with effective use of time and prioritization
• A working knowledge of ICH/GCP
• 10-20% travel requirement Key Team Membership:
• Clinical Study Team
• Clinical Operations Review
• Quality and Risk Reviews
• Kick off Cross Functional Interfaces
• Clinical Trial Managament
• Business Operations
• GCP Quality
• Strategic Sourcing & Procurement
• Vendor and Relationship Management
• TAPM
• Therapeutic Areas
• CLO 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.
Apply Now: https://ift.tt/2Tp2Q3g
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