Associate Centralized Monitor - German Speaker

About the role

IQVIA is looking for an Associate Centralized Monitor who speaks German and works in Sofia. The role provides project-related assistance to assigned project teams, ensuring work follows standard operating procedures, policies, good clinical practice and regulatory requirements while meeting quality and timeline metrics.

Key responsibilities

• Complete role-specific training and provide study-level administrative support under supervision, such as running system reports, preparing status reports and maintaining study trackers.
• Update and maintain systems within project timelines and assist Centralized Monitors in preparing i-site packs for sites and countries.
• Perform centralized monitoring on assigned sites, evaluating quality and integrity against protocol, SOPs and regulations, and follow up on missing data, queries and SDV backlog.
• Manage operational insight of sites and studies, including trend analysis, triaging clinical study alerts and monitoring COP compliance.
• Perform subject-level data review and study-specific analytics, and handle access management tasks such as processing access requests and vendor follow-ups.
• Act as backup for Centralized Monitors and Senior Centralized Monitors and support the technical solution specialist with Excel formulas, macros and tool design.
• Identify site-level risks, recommend corrective actions (e.g. site telephone contact or triggered onsite visits) and review their effectiveness.
• Follow the study central monitoring plan and the SOW as required by the customer.

Required profile

• Graduate or postgraduate in Life Sciences or a related field.
• Minimum of 2 to 5 years of work experience, with at least 1 year relevant; experience level may vary by customer.
• Good knowledge of ICH-GCP and relevant local laws and guidelines.
• Strong written and verbal communication in English and a good command of German.
• Attention to detail, problem-solving, planning and time-management skills, and strong data entry skills.

Required skills

• Proficiency in clinical systems such as EDC, IXRS or CTMS or equivalent.
• Experience managing global phase trials and clinical trial systems and reviewing clinical trial data.
• Microsoft Office, including Word, Excel and PowerPoint.