IQVIA AG seeks a Clinical Project Coordinator to support project leaders in managing clinical trial documentation, compliance, and reporting. This mid-level role ensures adherence to GCP, ICH, and internal SOPs while maintaining high customer satisfaction.
This position acts as a key support function for the Project Leader and Clinical Project Manager. The primary objective is to oversee project management activities, ensuring that all operations comply with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and relevant regulatory standards. Additionally, the role is responsible for maintaining high levels of customer satisfaction throughout the lifecycle of assigned projects.
Responsibilities
- Create, organize, and preserve project documentation, records, and reports in strict accordance with SOPs.
- Conduct reviews and audits of project files to verify accuracy and completeness.
- Track and coordinate the flow of information, communications, documents, materials, and supplies for designated studies.
- Administer study-specific electronic training programs and ensure team compliance.
- Maintain internal databases, tracking tools, timelines, and project plans within company systems.
- Generate and distribute status, tracking, and financial reports; assist in budget allocation and invoice approval processes.
- Organize and support internal study team and customer meetings led by the Project Leader.
- Record meeting minutes, notes, and action items, and follow up on assigned tasks.
- Prepare presentation materials and compile project summary data for meetings.
- Handle logistics and materials for project team and customer meetings.
- Identify and escalate discrepancies in project tracking data, timesheet coding, and expense billing.
- Establish and manage performance dashboards, analyzing event triggers and alerts.
- Monitor metrics and update IQVIA systems to ensure accurate and timely reporting for senior management.
- Coordinate the onboarding of new Key Members, including granting system access.
- Assist in the training and orientation of junior project support staff.
Requirements
- Bachelor's Degree in life sciences or a related field.
- 3–4 years of experience, or an equivalent combination of education, training, and professional experience.
- Solid understanding of clinical trials and applicable regulatory requirements, including GCP and ICH guidelines.
- Familiarity with clinical systems such as CTMS and experience with Trial Master File (TMF) filing.
- Strong written and verbal communication skills, with a good command of English.
- Effective problem-solving abilities.
- Results-oriented and detail-focused approach, with strong planning, time management, and prioritization skills.
- Proficient in software and computer applications, including MS Office.
- Ability to build and maintain effective working relationships with colleagues, managers, and clients.
- Capacity to work across different geographies, demonstrating high awareness and understanding of cultural differences.
Nice to have
- Experience with EAC reporting.
About the company
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support their clinical development efforts. The organization operates with an agile structure and fosters a collaborative culture.
- Exclusive partnership with biotech and emerging biopharma companies.
- Agile organizational structure.
- Collaborative work environment.
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