Associate Director, Medical Writing
GlobeNewswire
Google Cloud Platform
Job Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Act as direct contact with assigned sites, assess and ensure integrity of study implementation and adherence to protocol at clinical sites
- Build relationships with investigators and site staff; facilitate access to relevant study systems and ensure training compliance
- Evaluate site recruitment plan; provide improvement strategy; determine corrective actions and follow-up
- Address and resolve issues at sites, including training gaps, documentation deficiencies, and site questions
- Conduct on-site visits (Qualification, Initiation) and remote visits; generate visit reports
- Monitor site compliance, performance, and personnel; assess test article supply and site payments
- Review and follow-up site documentation and regulatory documents; ensure TMF submission and file maintenance
- Ensure CTMS/EDC/SIS data entry quality; maintain site data quality in CTMS and regulatory readiness
- Ensure compliance with ICH-GCP and local regulations; coordinate audits and inspections as required
- Provide site-specific training; conduct facilities assessments
- Collaborate with team, management, and sites to meet trial milestones and timelines
Requirements
- Minimum 1 year as a clinical monitor with demonstrated monitoring experience (virtual & onsite)
- Education: degree level (biological science, pharmacy, or health-related discipline) or equivalent nursing qualification or equivalent experience
- Proficiency in local language preferred; English required
- Sound problem solving skills; able to work independently and take initiative
- Advanced presentation skills
- Client-focused approach and professional interaction within client organizations
- Flexible attitude, ability to manage multiple tasks and meet timelines
- Willingness to work in matrix environment and value teamwork
- Strong computer skills (CTMS, EDMS, MS-Office)
- Excellent interpersonal, verbal, and written communication; sense of urgency
- Time management and organizational skills; cross-cultural adaptability
- Commitment to high-quality work and self-driven work style
- Ability to work effectively in a virtual team; may require travel and site visits
- Holds a driver's license where required
