Clinical Study Lead

About the role

This role is for an experienced Global Clinical Study Manager who leads complex, multinational oncology trials with a focus on Phase III registrational studies. The Study Manager is accountable for the operational delivery of clinical studies across one or more regions, ensuring adherence to Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines. The position requires a strong inspection-ready mindset, proven success in managing CROs and vendors, and the ability to drive study performance through robust oversight, proactive risk management, and cross-functional leadership.

Responsibilities

• Lead the end-to-end operational delivery of assigned global clinical studies, with primary accountability for time, cost, and quality outcomes.
• Develop comprehensive clinical study plans, including critical path activities, interdependencies, and timelines, using tools such as Microsoft Project.
• Lead the creation and implementation of cross-functional Clinical Study Oversight Plans, ensuring study team, CRO, and vendor adherence and proper documentation.
• Provide operational input into study protocol profiles, final protocols, and amendments to ensure feasibility and operational excellence.
• Coordinate and lead document review for protocols and amendments, and contribute to medical writing activities such as informed consent forms, case report form guidelines, investigator brochures, safety communications, DSURs, and IND-related documents.
• Drive and oversee CRO and vendor selection in collaboration with the study team and outsourcing/procurement functions, ensuring alignment with study needs and timelines.
• Manage trial feasibility and site identification activities in collaboration with the CRO and study team, and oversee the site qualification process.
• Maintain study budgets against trial progress, flag deviations to program and study leadership, and review and approve vendor invoices, including investigator grants and pass-through costs.
• Oversee CRO study start-up activities, coordinating with functional groups to ensure collection of essential site documents and timely site initiation in line with the study plan.
• Track and monitor site initiation and enrollment at country and site levels, and develop and implement enrollment mitigation strategies in collaboration with the CRO when challenges arise.
• Coordinate with CROs to plan and execute operational meetings, including vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings, and training sessions.
• Ensure CROs deliver high-quality, timely study documents and plans, including communication plans, site monitoring plans, and other operational documentation.
• Support the department in codifying existing knowledge, best practices, and lessons learned, and prepare and deliver training in areas of expertise.
• Recommend process improvements and innovations at the study and departmental level, and educate teams on SOPs, GCPs, and optimal use of operational tools.
• Maintain strong, routine communication with internal and external stakeholders, providing clear project status updates, escalating issues, and responding to operational inquiries.
• Act as a strong partner to other Study Managers and study leadership, contributing to a collaborative, high-performance team culture.

Essential Skills

• 5–6+ years of clinical and global study management experience in pharmaceutical or biotechnology settings.
• At least 5+ years of oncology clinical trial experience, with gastrointestinal (GI) oncology experience preferred.
• Significant hands-on experience with Phase III registrational (pivotal) studies, including supporting regulatory submissions.
• Prominent CRO oversight experience, including managing vendors, timelines, KPIs, and overall study performance.
• Demonstrated inspection readiness experience, with an inspection-ready mindset and familiarity with FDA inspections and/or mock inspections; FDA inspection experience strongly preferred.
• Strong clinical research, clinical operations, and clinical trial management expertise, including site management and study start-up activities.
• Experience navigating enrollment challenges and implementing effective mitigation strategies at country and site levels.
• Expert-level written and verbal communication skills suitable for executive-level and cross-functional stakeholder interactions.
• Strong decision-making abilities and clinical project management skills, with high attention to detail and quality.
• Ability to lead cross-functional teams and influence without formal authority in a fast-paced oncology environment.
• Proactive problem-solving skills, with the ability to identify issues early and drive practical solutions.
• Comfort working with and overseeing complex multinational trials, including coordination across regions and vendors.
• High level of professionalism, positive energy, and strong cultural and team fit, with the ability to build trust and partnerships across study leadership and peers.

Additional Skills & Qualifications

• Experience with Microsoft Project or similar project management tools for planning and tracking clinical study timelines and deliverables.
• Experience with Phase I and Phase II oncology trials and familiarity with investigational pipelines, including antibody-drug conjugates (ADCs) and other oncology assets.
• Background in working with global development programs across oncology, cardiovascular, and rare disease therapeutic areas is beneficial.
• Familiarity with key oncology and cardiovascular products and therapeutic targets, including breast, lung, gastric cancers, acute myeloid leukemia, atrial fibrillation, thrombotic disorders, hypertension, lipid metabolism disorders, osteoporosis, and other specialty indications.
• Experience contributing to or reviewing regulatory and safety documents such as DSURs, IND submissions, investigator brochures, and safety communications.
• Comfort presenting to and collaborating with cross-functional stakeholders including medical, clinical development, biostatistics, data management, regulatory, and quality assurance teams.
• Flexible and adaptable mindset, able to navigate evolving priorities, shifting timelines, and dynamic oncology development landscapes.
• Strong interpersonal skills, with the ability to foster collaboration, support other Study Managers, and contribute to a positive team environment.
• Ability to educate and mentor colleagues on SOPs, GCPs, and best practices in operational study delivery and vendor oversight.
• Interest in working within an organization that has a robust pipeline in oncology, immuno-oncology, pain management, neurodegenerative diseases, heart and kidney diseases, and rare diseases.