The Senior Manager, Study Start Up will be own 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.
- Lead all aspects of 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.
- Act as 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.
- This role may directly manage individuals who support Site Start Up activities. Up to 25% travel required.
Investigator/Institution Global Directory
- Coordinates the collection of relevant information to build 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
- Facilitates 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.
- Facilitates 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.
- Lead all aspects of 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 results 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 partners to establish global standard requirements for in-sourced and CRO led studies; Collaborates and supervises the CRO deliverables in compliance with SOPs and guidance.
- Supervises site start up staff
- May develop and deliver training to both internal and external CRO staff on Regeneron essential documentation policies, procedures and expectations
Bachelors degree or higher, preferably in Life Sciences, with at least 7+ years of relevant/clinical essential document review experience or equivalent experience.
- 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 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 supervising 3rd party service providers (CROs, Labs, etc.)
- Strong and focused project management skills; Ability to effectively multi-task and prioritize in a fast-paced environment
- Strong analytical skills and attention to detail; handling ambiguity; in addition to outstanding organization skills
- Optimally work across the organization and with outside vendors; Ability to work in a matrix environment. Good teammate with a positive demeanor
- Makes decisions on highly sophisticated 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
- 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.)
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.