Site Oversight Manager 0.5 FTE
TFS, Belgium
Job Description
TFS HealthScience is excited to be expanding our Strategic Resourcing Solution team and we are looking for an experienced, highly motivated Site Oversight Manager (SOM) who shares our vision of providing clinical research excellence. Our Strategic Resourcing Solution team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.
TFS HealthScience is looking for a Site Oversight Manager home based in Belgium.
The Site Oversight Manager will act as a local liaison between sponsor, CRO CRAs and investigator sites in order to support program specific corporate targets (achieve or exceed), identify and mitigate potential issues and support oversight activities.
Key Responsibilities
- Obtain relevant knowledge about the assigned region - treatment standards, patient pathways, healthcare system, competitive landscape, clinical trial regulatory environment, patient advocacy groups, Key Opinion Leaders (KOLs), site capabilities and past performance etc.
- Assist applicable sponsor Teams with creation of country specific plans to target appropriate national patient support/advocacy groups in order to influence patient recruitment.
- Provide input to applicable sponsor Teams’ site level recruitment targets and recruitment methodologies (enrolment plan).
- Understand local and country regulatory authority and EC requirements to provide support during regulatory and EC submissions and approvals.
- Create strong relationships with all relevant site personnel in order to facilitate timely meeting of clinical trial targets (ie, enrollment, data entry, query resolution, etc).
- Site motivation visits to boost screening and enrollment activities.
- Work proactively with sites to resolve/mitigate any issues, create site risk plans, share learnings from other sites, and manage any requests in collaboration with applicable sponsor Teams.
- Create a close, trustful, and engaged collaboration with counterparts in CRO, in order to have joint strategy for meeting the trial targets. Lead/attend joint regular local/global CRO/CSRM meetings.
- Support CRO CRAs and applicable sponsor Teams to ensure each site’s on time delivery of database lock milestones.
- Based on communication with sites, report/discuss learnings and escalate issues identified to applicable sponsor Teams. Support any site issue mitigation strategies as needed.
- Support oversight of site-level CRO activities to ensure quality of site and CRO:
- Monitoring Oversight visits to focus on both CRA and site performance. During visit, review previously monitored patients, ensuring compliance with SOPs, protocol, ICH GCP and applicable regulatory requirements.
- Review relevant site-specific metrics to keep track of site performance.
Site visit expectations:
SOM to visit all sites Face-To-Face when relationship initiated, and as needed throughout the trial. Virtual meetings may be arranged as well. Key sites may be identified to be visited Face-To-Face more frequently than others.
Types of SOM visits:
- Site visits prior to Site Initiation Visit, to ensure site is ready for start-up and help resolve issues hindering activation.
- Site Initiation Visit (CRO CRA owns the meeting, SOM and/or CTM attends as sponsor representative).
- Enrolment booster visits.
- Monitoring Oversight visits.
- Ad hoc site training/re-training visits, as agreed with applicable sponsor Teams.
Requirements
- Bachelor’s Degree or Masters degree in relevant discipline.
- Solid experience in the pharmaceutical/Clinical Research industry
- Experience working as Clinical Research Associate, Monitor or similar.
- Experience with site management from Pharma, Biotech or CRO.
- Demonstrated experience of working directly with investigator sites and investigators.
- Strong knowledge of ICH GCP.
- Demonstrated relationship building skills with investigator sites (on site and remote).
- Excellent networking skills with internal and external stakeholders.
- Excellent written and verbal communication ski