The Position
The Clinical Trial Manager Team Lead provides strategic leadership and operational oversight at the Regional/Operative Unit (R/OPU) level to ensure successful planning, execution, and reporting of high-quality clinical trials, in alignment with corporate and functional objectives. This role is pivotal in hiring, onboarding, managing and developing a team of Clinical Trial Managers (CTMs). The role fosters a high-performing team culture to deliver R/OPU clinical trials that meet pipeline commitments within agreed timelines, budgets, recruitment-goals and scientific standards.
The primary responsibilities involve overseeing CTM performance and ensuring adherence to regulatory, ethical, and quality standards, while fostering collaboration with both internal and external partners to meet organizational objectives.
In addition, the role manages efficient resource allocation, guarantees consistency with global and R/OPU strategies, and encourages cross-functional alliances to sustain operational excellence. The Clinical Trial Manager Team Lead plays a crucial role in driving process optimizations, improving team skills, and meeting pipeline commitments, all while emphasizing performance management, quality, efficiency, and a focus on site/patient-centricity.
Duties & Responsibilities:
- Lead and oversee CTM operations at R/OPU level to ensure delivery of clinical trial pipeline aligned with Human Pharma priorities.
- Ensure CTMs understand their roles, responsibilities, and deliverables across planning, execution, and delivery.
- Promote best practices using data, technology, and customer engagement to enhance site and patient value.
- Model and integrate organizational behaviors into daily leadership.
- Partner with R/OPU Head of CDO and HR to identify, develop, and retain CTM talent.
- Build and sustain a skilled CTM workforce through recruitment, onboarding, and development.
- Manage team performance, development planning, and MAG reviews.
- Foster a motivating and cohesive environment that supports growth and CDO identity.
- Oversee CTM resourcing, capacity planning, and trial allocation for optimal delivery.
- Ensure recruitment and onboarding of qualified CTMs to maintain team strength and dynamics.
- Drive continuous improvement and efficiency initiatives aligned with global strategies.
- Contribute to initiatives enhancing quality, compliance, and CDO delivery.
- Encourage innovation through adoption of new technologies and methodologies.
- Build strong internal and external stakeholder relationships for cross-functional collaboration.
- Represent CDO in interdisciplinary and global working groups to enhance trial strategies.
- Ensure CTMs manage trials effectively from planning to closure, focusing on quality, timelines, recruitment, cost, and resources.
- Lead inspection readiness and sponsor oversight at R/OPU level.
- Support CTMs in resolving trial-related issues and maintaining oversight.
- Oversee trial issue management to ensure high-quality delivery.
- Direct CTM performance in patient and site engagement.
- Promote customer-centric behaviors and responsiveness.
- Empower study teams to own and resolve issues collaboratively.
- Cultivate a culture of continuous improvement and operational excellence.
- Lead change management for global and R/OPU initiatives, driving adoption and innovation.
- Ensure the quality, integrity, and compliance of clinical trial activities by adhering to all applicable regulatory, legal, and ethical standards.
- Ensure strict adherence to ICH GCP, local regulations, industry guidelines, BI SOPs, and internal policies to safeguard participant rights, safety, and data integrity.
- Conduct all trial-related activities with the highest ethical and professional standards, reflecting BI's values and commitment to quality.
- Perform all supervisory and leadership responsibilities in alignment with BI policies, regulatory requirements, and best practices.
- Drive continuous quality improvement while maintaining compliance with BI SOPs and regulatory standards, ensuring alignment with BI's strategic objectives.
Requirements:
- Bachelor's degree in Life Sciences, Biomedical Sciences, Health Sciences, or related field Master's degree is a plus
- At least 8 years of experience in clinical research, preferably within the pharmaceutical or healthcare industry
- Minimum 3 years of experience in line or matrix team management
- Minimum 3 years of experience leading, developing, and inspiring high-performing teams
- Strong strategic thinking and problem-solving skills aligned with organizational goals
- Clinical trial project management experience is a plus
- Clinical research experience within ASKAN is an advantage
- Excellent communication and stakeholder engagement skills across diverse audiences
- Skilled in cross-functional collaboration and building effective networks
- Innovative mindset with proficiency in digital tools and process improvement
- High integrity and commitment to ethical standards, regulatory compliance, and patient safety
- Strong project management skills with accountability for quality, timelines, and resources
