Global Site Management Specialist - London - ref. b0724719
Specifically, the Specialist, GSM is responsible for supporting the Clinical Trial Liaison (CTL) team with country and regional site management, including feasibility support, issue management tracking and the analysis of performance and operational data.
In addition, the Specialist GSM works closely with the Monitoring Strategy and Oversight team supporting the Monitoring Oversight business process and monitoring plan/monitoring strategy creation and tracking, including representing GSM during relevant external interactions with vendors and CRO partners.
This individual is expected to represent GSM in cross functional group meetings and forums in partnership with other Global Clinical Trial Services (GCTS) functions and Clinical Trial Management (CTM). The Specialist is responsible for all aspects of role onboarding, functional document inventory management and maintenance of the functional share-point site and Academy sites.It is expected that the individual is trained in all aspects of ICH-GCP and relevant local operational and regulatory requirements.
- Serves as Co-chair of Regional CTL Meetings
- Responsible for and acts as the custodian of the GSM Sharepoint and Academy Pages
- Responsible for Staff Onboarding (includes role-based training assignments, system accesses etc)
- Performs site management activities, when delegated, to ensure compliance to the protocol, monitoring plan, ICH GCP, REGN SOPs, and local operational and regulatory requirements.
- Partners in-country/region with study assigned Clinical Trial Liaison (CTL) to optimize clinical trial deliverables.
- Partners with other REGN roles and functions (eg. SB&C, SSU, CTM, GTO) to support site feasibility, activation, enrolment, close out and issue management.
- Provides metrics and data in support of International Medical Affairs and GSM in-country reviews
- Tracks monitoring strategies and monitoring plan versions.
- Supports the Oversight Monitoring business process (reviews, actions, and outcomes)
- Provides project support for Next Generation Monitoring (NGM)
- Represents GSM during applicable internal and external stakeholder meetings (CRO KO meetings, feasibility KO meetings, FSP vendor meetings, issue management and deep dives)
- Maintains functional metrics repositories (eg Qliksense) and generates reports as required
- Tracks and reports to GSM Leadership the monthly COR outcomes
- Tracks and reports to GSM Leadership the Clinical Trial Liaison performance metrics
- Participates in relevant process improvement initiatives.
JOB REQUIREMENTS:
List knowledge, skills, and abilities required to perform the job.
List any preferred job requirements as well.- Problem solving abilities, troubleshooting and critical thinking
- Ability to work independently as well as part of a cross functional team
- Analytical problem-solving experience
- Working knowledge of clinical drug development process as well as ICH GCP
- Effective communication and interpersonal skills; ability to build relationships internally and externally
- Familiarity with medical terms
- Demonstrates writing skills to deliver messages effectively so messages are clearly understood
- Proficiency in required IT applications (includes EDC, CTMS, data repositories and MS Office applications)
- Ability to travel up to 20%
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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.The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.