Manager Site Start Up

The Manager, Site Start Up is central to advancing REGN's document management and communication capabilities. With a focus on extended Veeva Vault Clinical system implementation and Site Portal, we expect that you will ensure the systems' usability, efficiency, and alignment with business objectives are optimal. We believe the Manager will also be responsible for the introduction and adoption of relevant technologies that enable business processes.
Site Initiation and Regulatory Packages
Gathers all documents required for the purposes of enabling Site Initiation; includes the compilation of documents from multiple internal stakeholders and supporting functions to then distribute to the site in a structured and time sensitive manner.
Identifies and tracks those documents that require translations/linguistic validations and works with translation support services to define the scope of work and critical timelines for deliverables.
Participates as necessary, in obtaining clinical trial insurance for studies/sites Facilitates the clinical trial insurance process; works as necessary with the insurance vendor and Regeneron insurance group to ensure timely deliverables in preparation for patient enrollment and support throughout the conduct of the clinical study. May contribute to review of Subject Informed Consents to ensure alignment with insurance language.
Study Investigator Site Essential Document Oversight
Serves as study expert on investigator site essential documentation
Develop and maintain Regeneron documentation of expectations / standards of investigator site essential documentation
Provide training to internal and external study teams on the expectations / standards of investigator site essential documentation.
Review investigator site essential documentation packages from CROs per process and sample as needed
May collaborate directly with sites regarding collection of documents and IRB timelines for site activation and ensure that relevant documents are uploaded into the eTMF.
Collect study specific metrics and feedback and provide to internal and external study teams (including CRO partners) and Regeneron management as required.
Assists in inspection readiness activities in relation to Site Start Up documents
Participates in lesson learned opportunities to retrain study teams and CROs understand what has worked or not to prevent repeating past mistakes.
Study Team Interaction
May represent Site Start up on cross-functional study team (s) and/or sub-team(s); Attends Kick Off meetings to present SSU Roles and Responsibilities
Works with and provides status to study team to ensure essential documentation packages are approved for initial drug shipments according to study timelines. Supports Clinical Study team in ensuring regulatory documents are submission and audit ready escalates as necessary
Collaborates with CRO and internal team to ensure timely feedback / resolution of document issues
This role may be for you if you have:
Experience in the clinical drug development process, specifically trial planning and execution practices, including IRB/IEC and Investigator site roles and responsibilities
Knowledge and understanding of ICH/GCP and regulatory guidelines/directives, especially ICH E6 R2
Experience in managing Sponsor and Site related contact information and essential documents
Experience in the creation and management of Investigator and Institution contact information in a CTMS
Experience in registering essential documents within the Trial Master File
Demonstrates expert knowledge in own field, with a strong understanding of adjacent areas for the development of pragmatic and creative solutions
Works with management to support the development of department strategy, operational objectives, and matters of significance
Achieves goals in creative and novel ways, operating with significant autonomy
Makes decisions on complex to highly complex issues regarding work approach for project components and completion of team tasks and responsibilities
May provide input into performance reviews and corrective actions for staff
Great teammate with a positive attitude and resilience
Good communication and inter-personal skills
Strong project management and prioritization skills
Attention to detail and ability to problem solve and generate results
Ability to multi-task and work in a fast-paced environment
Familiarity with CROs and support models for Site Activation
In order to be considered qualified for this role , we are looking for individuals who have a bachelor’s degree (Master’s degree preferred) with 5+ years of relevant industry experience. We also expect candidates to be onsite a couple days a week at one of our New York Metro offices.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually) $110,900.00 - $181,100.00