Regeneron Pharmaceuticals Hiring for Sr. Manager, Study Start-Up at Basking Ridge, New Jersey Full Time

· The Senior Manager, Study Start Up will be responsible for leading the collection, distribution, receipt, review and registry of essential documents required for release of Investigational Product to participating investigator sites and any updates required as a result of document expirations and related protocol amendments.

· Will oversee planning and tracking against the investigator list creation, investigator assessment for eligibility/usability and selection to ensure that Site Essential Package distribution occurs in a time sensitive manner. Will also plan and track against Site Initiation and Site Activation timelines to drive against key study timelines.

· Will serve as the primary contact for acquiring insurance documents on behalf of the clinical study team. They will serve as the main liaison between Regeneron/CRO and the insurance broker/carrier.

The Senior Manager, Study Start Up may directly manage individuals who support Site Start Up activities. Up to 25% travel required.

Essential Functions required for the job. List both technical and managerial requirements if applicable.

Investigator/Institution Global Directory

• Oversees the capture of relevant information to create an investigator site entity within the CTMS system to enable site association with a clinical trial

• Gathers, tracks and reports on the status of Site Activation tasks/activities/deliverables to generate insights on Study and Site status; manages and maintains the study start up metrics and dashboards and provides periodic updates to management.

Site Initiation and Regulatory Packages

• Facilities the sharing of Sponsor specific documents (e.g. Protocol, Master Informed Consent Form, Investigator’s Brochure and other supporting documents) in order to receive and process Investigator Site related documents required prior to shipment of product to an investigator site.

• Facilities the translation of Essential Documents that may be required in languages other than English for the purposes of submission to and approval from Regulatory Health Authorities and/or Independent Review Boards/Ethics Committees.

• Oversee as necessary, clinical trial insurance process as an escalation point for Start Up Manager in working through issues with the insurance broker and Regeneron insurance group to ensure timely deliverables and support throughout the conduct of the clinical study.

• Contributes to the development and maintenance of Standard Operating Procedures and Work Instructions to communicate and promote compliance to standard process and procedures.

• Collaborates with stakeholders to establish global standard requirements for insourced and CRO managed studies; Collaborates and oversees the CRO deliverables in compliance with SOPs and guidance.

• Supervises site start up staff as necessary.

• May develop and deliver training to both internal and external CRO staff on Regeneron essential documentation policies, procedures and expectations

• Supports internal audit and external inspection activities; contributes to CAPAs as required.

• Participates in continuous improvement activities for essential document related tasks/activities/deliverables and associated processes.

Job Requirements

• Experience in clinical drug development process and clinical trial planning and execution practices, including IRB/ERC and Investigator Site roles and responsibilities

• Knowledge and understanding of ICH/GCP and regulatory guidelines/directives, especially ICH E6 R1 and R2

• Experience in managing Sponsor and Site related Essential Documents, including the use of CTMS for Site Creation & management, TMF, the Master Index, Sponsor vs. Site requirements

• Familiarity in engaging with and overseeing 3rd party service providers (CROs, Labs, etc.)

• Strong and disciplined project management skills; Ability to effectively multi-task and prioritize in a fast-paced environment

• Strong analytical skills and attention to detail; managing ambiguity; in addition to superior organization skills

• Ability to effectively work across the organization and with outside vendors; Ability to work in a matrix environment. Good team player with a positive attitude

• Works with senior management, consults on solution development for novel, out of policy, or strategic business and technical issues

• Makes decisions on complex to highly complex issues regarding work approach for project components and completion of team tasks and responsibilities

• Regularly makes decisions under minimal guidance that have a significant impact on the organization’s financial and business operations

• Anticipates business needs, secures required resources, and leads initiatives to implement change in the organization

• Good communication and interpersonal skills; Effective problem-solving skills; Strong ability to prioritize and drive for results

• Technical proficiency in MS/iOS applications including (but not limited to) Microsoft Project, PowerPoint/Key Note, Word/Pages, Excel/Numbers, Electronic Document Management Solutions (Veeva, NextDocs, etc.)