Global Clinical Trial Leader

OVERVIEW


We are currently seeking an experienced Global Clinical Trial Leader (CTL) to join a well-known client’s team onsite three times per week in South San Francisco, CA. This role is responsible for the execution and delivery of early-phase global clinical trials and for supporting innovative development programs involving new molecular entities.


The CTL will play a critical role in driving global study execution, collaborating with cross-functional teams, managing vendors, and implementing flexible operational strategies. This position offers the opportunity to lead complex studies in a fast-paced environment while contributing to the advancement of novel therapeutics and improving patient outcomes.



RESPONSIBILITIES


Study Execution & Team Collaboration


•    Provide operational leadership and guidance to global cross-functional Protocol Execution Teams (PETs) across all study stages (start-up, conduct, and close-out).


•    Drive high-quality delivery of key study documentation, including vendor specifications, drug supply forecasts, monitoring plans, TMF, and CTMS data.


•    Foster a collaborative and accountable team culture that promotes innovation and high performance.


•    Coordinate investigator meetings and ensure alignment across stakeholders.


Vendor & Budget Management


•    Support vendor selection and provide oversight to ensure CROs and vendors deliver according to scope, quality, and timelines.


•    Manage vendor performance and ensure compliance with contracts and deliverables.


•    Contribute to study budget planning and manage assigned financial responsibilities.


Strategic Planning & Execution


•    Provide operational input for clinical trial design, protocol development, and feasibility assessments.


•    Support country and site selection activities.


•    Identify risks and proactively develop mitigation strategies to ensure study success.


•    Manage study timelines and address bottlenecks with actionable solutions.


•    Maintain a strong focus on patient and site-centricity throughout study execution.


Cross-Functional Impact & Leadership


•    Partner with stakeholders to drive process improvements and operational best practices.


•    Serve as a subject matter expert (SME) for clinical trial execution initiatives.


•    Mentor and support the development of junior team members and peers.


•    Champion change initiatives and support continuous improvement across clinical operations.



EXPERIENCE


•    Minimum of 8 years of clinical study management experience.


•    Demonstrated experience managing global Phase I and II clinical studies.


•    Proven expertise in vendor and CRO management.


•    Strong experience in risk identification, mitigation, and study execution strategy.


•    Experience working in a global, cross-functional clinical environment.



EDUCATION


•    Bachelor’s degree required (scientific or healthcare discipline preferred).



TO BE A BEST FIT, YOUR STRENGTHS MUST INCLUDE


•    Strong leadership skills with the ability to influence cross-functional teams.


•    Excellent communication and stakeholder management capabilities.


•    Strong problem-solving and critical thinking skills in complex environments.


•    Ability to manage multiple priorities and adapt to changing business needs.


•    Deep understanding of GCP/ICH guidelines and global regulatory requirements.


•    Strategic mindset with the ability to translate operational challenges into solutions.


•    Collaborative and proactive approach with a strong focus on patient outcomes.


•    High degree of professionalism, accountability, and adaptability in fast-paced settings.


 

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.


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