Director, Onboarding Process Optimization
Hyatt
Director, Biostats and Data Management
Meridian Bioscience Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Oversee and facilitate the personal development of the clinical data team (data managers and biostatisticians) including fostering career growth, and providing relevant company-specific, ethical, and regulatory trainings.
- Responsible for setting the strategic vision for the clinical data team to ensure high quality data and data analysis to support regulatory submissions.
- Strategic leadership, organizational, and operational management and guidance to the personnel and teams within the clinical data team.
- Lead the data team to ensure project timelines are met, with appropriate quality based on company priorities.
- Responsible for technical review of functional deliverables, including clinical study protocols, statistical analysis plans and reports, final study reports, and publications including abstracts and posters for the clinical data team.
- Partner with cross-functional leaders to optimize collaboration, resolve cross-functional operational challenges, and leverage resources efficiently.
- Champions the development, maintenance and implementation of processes and tools to ensure all external data follow data management plans, statistical analysis plans, applicable standards, study protocols, SOPs and overall clinical objectives.
- Lead the continued development, review and updating of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards.
- Implement the corporate strategic plan within the clinical data team and collaborate with senior leadership with defining and managing the clinical data team budget, as required.
- Expertise in working with Electronic Data Capture (EDC) systems and clinical data management systems like Medrio.
- Responsible for staffing of the clinical data team for assigned projects.
- Maintain effective communication, coordination and working relations with other personnel and management, as well as director board, at the Quebec site.
- Must be able to concentrate, analyze and solve complex issues throughout the course of the work shift.
Requirements
- Bachelor’s Degree (advanced degree preferred) with 10+ years relevant work experience in clinical data management
- 10+ years of experience mentoring, managing, and leading a team
- Working knowledge of US Good Clinical Practices (GCP) is required
- 10-15 years working in the Medical Device/ Pharmaceutical/Biotechnology/ CRO Industry, IVD experience required.
- Fluent in French is preferred
Benefits
- Competitive salary
- Flexible working hours
- Professional development budget
- Home office setup allowance
- Global team events
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical data managementdata analysisstatistical analysisclinical study protocolsstatistical analysis plansElectronic Data Capture (EDC)MedrioSOP developmentregulatory submissionsbudget management
Soft skills
strategic leadershiporganizational managementoperational managementmentoringcommunicationproblem-solvingcollaborationcareer developmentteam leadershipcoordination
Certifications
Bachelor’s DegreeGood Clinical Practices (GCP)
