Clinical Trial Manager – Real World Evidence

This is a fully remote position, open to applicants in Bulgaria, +3 more countries.

📋 Description

• Provide operational oversight for milestones and activities related to assigned projects.

• Manage site management and monitoring tasks, which include remote oversight by Site Management Associates (SMAs) and onsite monitoring by Clinical Research Associates (CRAs).

• Oversee site activation, communication, visit planning, document collection and maintenance, regulatory approvals, and site closure.

• Record clinical activities within a Clinical Trial Management System (CTMS).

• Create site monitoring and management plans.

• Develop and facilitate training for the clinical team.

• Review trip reports and proactively identify risks along with mitigation strategies.

• Analyze metrics and dashboards that support oversight of clinical operations.

• Lead data review and query management activities as required.

• Collaborate with the RWS Project Manager, Finance, and Data Management to ensure delivery within the defined scope, timeline, and budget.

• Provide sponsors with metrics and essential study updates.

• Plan and manage the clinical operations components of trials and studies.

• Collaborate with global cross-functional teams on protocols and procedures.

• Build and nurture relationships with investigators and stakeholders.

• Ensure adherence to applicable regulations and ethical standards.

• Make decisions regarding trial design, vendor selection, and risk management.

• Lead the clinical team to execute studies in alignment with sponsor expectations.

⛳️ Requirements

• A university degree in medicine, science, or a comparable combination of education and experience.

• A minimum of 2 years of experience in a similar role within a CRO or pharmaceutical company.

• Extensive exposure to Real World Evidence (RWE) Clinical Trial Management.

• Proven ability to drive the clinical deliverables of a study.

• Experience in various clinical studies across different therapeutic areas in Phases III and/or IV.

• Previous experience with risk-based monitoring (RBM) oversight is preferred.

• Willingness to travel as necessary (approximately 15%).

• Capability to manage multiple projects or clients simultaneously based on assigned Full-Time Equivalent (FTE).

• Demonstrated strong time management abilities.

• Experience in non-interventional studies is a plus but not mandatory.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage when applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.