Senior Decentralized Clinical Trial Study Lead

This is a fully remote position, open to applicants in Serbia, +5 more countries.

📋 Description

• Strategically design and implement decentralized clinical trial studies in accordance with contracts while enhancing speed, quality, and cost efficiency.

• Ensure the consistent application of study tools and training resources while adhering to system updates, processes, policies, and procedures.

• Provide oversight for DCT projects and act as the primary customer contact, managing relationships with key customer stakeholders.

• Establish objectives for the DCT project team, communicate and evaluate performance, and offer feedback and leadership.

• Collaborate with functional teams and core study groups to develop integrated study management plans, support milestones, and address issues and challenges.

• Monitor progress against contractual obligations and proactively prepare and present project updates to both internal and external stakeholders.

• Oversee problem-solving and resolution activities, including risk management, contingency planning, and issue resolution.

• Create proactive contingency plans to minimize risks.

• Identify and manage quality-related risks and issues while implementing corrective and preventive action plans.

• Ensure the financial success of projects through optimal resource allocation and assignment to meet goals and profitability targets.

• Forecast and identify opportunities to expedite activities, milestones, and revenue generation.

• Recognize scope changes and manage change control processes, including obtaining customer approval for financial and milestone adjustments.

• Identify and share lessons learned and best practices for ongoing improvement.

• Engage in bid defense preparations and lead presentations for fully virtual studies or as part of integrated hybrid DCT teams.

• Embrace corporate initiatives and act as a change advocate.

• Provide feedback on the performance of project team members, support staff development, and mentor less experienced colleagues.

• Train and educate teams and partners on DCT processes, capabilities, and organizational structure.

• Collaborate with IQVIA business development representatives.

• Participate in executive committees as part of program leadership.

⛳️ Requirements

• Bachelor’s Degree in Life Sciences or a related field is required.

• 5 years of relevant clinical research experience or an equivalent combination of education, training, and experience.

• Advanced knowledge of and experience with Project Management methodologies, preferably within the clinical research sector.

• Comprehensive understanding of decentralized clinical trials (DCT), including current challenges and opportunities for improving clinical trial execution.

• Knowledge of clinical trial execution and applicable regulatory requirements in clinical research, including ICH GCP and relevant local laws, regulations, and guidelines.

• Broad protocol knowledge and therapeutic expertise are preferred.

• Proficient command of the English language.

• Exceptional written and verbal communication, presentation, negotiation, and customer management abilities.

• Strong problem-solving capabilities.

• Ability to leverage others to achieve results, monitor/manage performance, and provide constructive feedback.

• Effective planning, time management, and prioritization skills.

• Ability to manage conflicting priorities and strategically work toward project objectives.

• Attention to detail, accuracy, results-oriented mindset, learning agility, and willingness to learn.

• Proficient software skills, including Microsoft Word, Excel, and PowerPoint.

• Ability to establish and maintain effective working relationships with colleagues, managers, and clients.

• Excellent customer service, mentoring, and training abilities.

• Capacity to work across different geographical locations with an understanding of cultural differences.

• Understanding of IQVIA functions and their interrelationships with Project Leadership.

• Familiarity with project financials, including financial management and contractual obligations/implications.

🏝️ Benefits

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible working arrangements to promote work-life balance.

• Access to a collaborative and innovative work environment.