Project Manager, Trial Lead - FSP

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• Act as the main project-level liaison between the sponsor and the organization.

• Ensure adherence to internal and external escalation protocols and communication guidelines.

• Determine roles and communication structures for secondary project leads as necessary.

• Oversee comprehensive cross-functional project delivery concerning time, cost, and quality.

• Manage financial aspects of the project, including contract comprehension, resource-budget alignment, out-of-scope activities, change-order negotiations, and team execution timelines.

• Establish, communicate, and maintain customer expectations effectively.

• Facilitate project-level risk identification and issue resolution utilizing RBQM/RESOLVE methodologies.

• Ensure compliance of the project team with organizational policies, SOPs, ICH-GCP, regulatory mandates, and project-specific requirements.

• Lead cross-functional project teams to achieve or surpass deliverables.

⛳️ Requirements

• Bachelor's degree or equivalent with relevant formal academic or vocational qualifications.

• Over 6 years of experience in clinical operations management, overseeing clinical trials in alignment with quality, timeline, and budget expectations.

• Proficiency in technical and system tools, including Microsoft Outlook, Word, Excel, PowerPoint, CTMS, Preclarus, and Clarity.

• Capability to delegate and prioritize personal and project team workloads in a dynamic environment.

• Strong oral and written communication, along with presentation skills.

• In-depth knowledge of therapeutic areas and clinical development guidelines and directives.

• Comprehensive understanding of project management principles related to time, quality, and cost.

• Solid financial understanding.

• Strong interpersonal and customer service capabilities, including leading, motivating, and coordinating cross-functional project teams.

• Proficient in judgment, decision-making, critical thinking, analytical thinking, and strategic thinking skills.

• Ability to negotiate, persuade, and influence others effectively.

• Awareness of cross-cultural dynamics.

• Compliance with organizational policies, SOPs, ICH-GCP, regulatory standards, and project-specific requirements.

• Willingness and capability to work in office, laboratory, and/or clinical settings.

• Ability to work with potential exposure to biological fluids, infectious organisms, and electrical office equipment.

• Competence in utilizing necessary personal protective equipment, including eyewear, garments, and gloves.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Chance to contribute to scientific excellence and innovation.