Beschreibung

In this role, you will lead local clinical trial operations, ensuring studies are delivered on time and within budget. You will collaborate with cross-functional teams, manage site selection, and maintain compliance with regulatory standards, all while driving quality outcomes for clinical research.

Anforderungen

• •Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• •Previous experience in a CTM role comparable to 3+ years
• •Experience in site monitoring
• •Flexibility and resilience in changing environments
• •Excellent leadership skills
• •Excellent understanding of clinical study and drug development
• •Strong project management approach
• •Proficiency in acting as spokesperson to external stakeholders
• •Ability to work effectively in a remote environment
• •Solid understanding of local regulations and ICH-GCP guidelines
• •Willingness to travel for project-related activities
• •Ability to use and learn standard office equipment
• •Ability to perform successfully under pressure

Aufgaben

• •Achieve final clinical deliverables within contract timelines
• •Interpret project data and make informed business decisions
• •Ensure clinical deliverables meet time, quality, and cost expectations
• •Maintain profitability by managing clinical activities within contract scope
• •Lead the local study team and provide matrix leadership
• •Serve as the operational point-of-contact between central and local study teams
• •Collaborate with local medical and regulatory affairs staff
• •Conduct study feasibility and site selection within the country
• •Select sites and ensure local study performance
• •Deliver assigned studies to meet time, budget, and quality expectations
• •Develop and maintain country study plans and timelines
• •Provide troubleshooting and problem resolution support
• •Manage local supply inventory and ensure necessary supplies are available
• •Ensure accuracy of study systems and trial master file
• •Report study delivery progress to stakeholders
• •Review and monitor key risk and performance indicators
• •Develop country/site-level risk assessments and mitigation plans
• •Review and approve monitoring visit reports
• •Provide feedback on local study team performance
• •Create and manage study budgets and track expenditures
• •Negotiate contracts with sites, CROs, and vendors
• •Manage local vendor relationships and oversight
• •Develop key study documents according to local requirements
• •Prepare local Informed Consent Forms and submit Clinical Study Applications
• •Maintain communication with regulatory authorities and ethics committees
• •Acquire knowledge on study compounds and local healthcare requirements
• •Assist with audits and inspections of clinical operations
• •Continuously develop knowledge in GCP and internal guidelines
• •Train in-country staff and coordinate local study meetings
• •Escalate resourcing issues for in-country study activities
• •Ensure robust communication with study sites
• •Review and approve Monitoring Visit Reports in a timely manner
• •Manage study-specific safety issues and reporting
• •Contribute to end-of-study learning debriefs and identify improvements
• •Collaborate with country study staff and other functions
• •Communicate effectively with senior medical staff and key partners