Manager Medical Study Operations

Location
Sleepy Hollow, New York
Posted
May 06, 2022
Ref
REGEA0026R10635
Required Education
Bachelors Degree
Position Type
Contract

As a Manager, Medical Operations you will be responsible for projects and programs with moderate direction related to: Investigator Initiated Studies, Pre-Clinical Collaborations, Sample Analysis Studies, Collaboration studies, Compassionate Use, Data Transparency, Ph4 Registries, RWE HEOR Studies, and Company Sponsored Phase 4 Interventional Studies. 

A typical day of may include the following: 
Ensures all proposals are complete and all relevant decisions are acquired prior to a moving approved studies forward. 
Facilitates our Medical Affairs meetings & committees, sets agenda, drives goals, documents meeting outcomes, and follow-up for any action items 
Responsible for obtaining internal approval of associated study budget, ensuring Fair Market Value analysis on-line items has been completed. 
Managing ongoing Purchase Order’s reporting to Accounting & Finance 
Processes budget changes and reforecasts, ensuring open communication with internal partners
Reconciles budget on regular interval schedule, and ensures all payments processed prior to PO closure.
Proactive drug campaign planning for various programs in advance of study initiation for individual studies/programs, country specific requirements, and ensuring Import Licenses are obtained and QPV release occurs when necessary. 
Ensuring timely drug shipments and resupply and clear communication occurs regarding expiry and quarantines, temperature excursions processing, and ensures drug destruction occurs for any unusable product. 
Responsible for analyses, tracking and reporting of study progress versus timelines committed by investigator, data delivery and program impact, and other related metrics
Coordinates contracting with Legal, Procurement, and Sites, ensuring contract terms are correct and inclusive of any required special contractual agreements.
Ensures Patent reviews and Due Diligence Process are completed (OIG exclusion list, FDA debarment list, Anti-Bribery-Anti-Corruption background checks
Manage vendors from RFP and vendor selection thru contracting and study implementation. Ensure study deliverables from the vendors are met.
Ensures collection, tracking and archiving of all relevant documents. 
Ensures timely receipt, tracking and distribution of SAEs, Investigator Alert Letters (IAL), and reconciliations. Periodically runs compliance reports to ensure timelines are within acceptable range. 
Ensures internal publications review, consolidates comments, receipt by Investigator, and documents actions taken. 
Collecting PK, ADA, or genetics samples, or for studies providing clinical samples, ensures timely shipments, reconciliations, analysis and data delivery when appropriate.
Ensures data capture into Project software (COMPASS), supports the entry of submissions and data management within the ERRS portal, and QC’s SharePoint document storage for completeness and audit readiness.
Coordinates project/program alignment with Alliance and internal partners, driving activities forward, and communicating potential risks and solutions. 

This may be for you if: 
•    You want to make a difference in the lives of patients
•    You demonstrated experience in clinical trials.
•    You enjoy working rapid-response environment

To be considered for this you should have a minimum BA/BS degree in a related field preferably life sciences. 5+ years active work experience in clinical research, regulatory or a field-based function in pharmaceutical and/or biotech industry and experience or courses pertaining to clinical research and/or MA functional areas. 10+ years active experience in specific area of clinical research will be acceptable in lieu of a degree. 


Preferably experience with a science background with active experience ideally in multiple therapeutic areas and/or antibody research. 

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.