Study Leader

Job Description Summary

The Study Leader co-leads together with the Clinical Science Lead (CSL) the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives.
Contributes in promoting operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs.

 

Job Description

Key responsibilities:
 

• Co-leads clinical trials, promotes operational excellence with agile principles, and ensures on-time delivery of studies.

• Fosters an agile culture within assigned studies to maximize collaboration and achieve long-term business impact.

• Collaborates with regulatory writing and clinical development to develop global clinical trial protocols and study-related documents.

• Maintains up-to-date study status, risks, and issues, and ensures readiness for inspections and audits.

• Oversees study recruitment and works closely with SSO Clinical Program Managers and Vendor Partnerships & Governance to deliver clinical study objectives.

• Ensures proper handling of all study close-out activities such as site close-outs and final drug accountability.

• Contributes to the development of clinical study reports, and partners with Portfolio Strategy & Planning to align studies with program strategy.

• Builds high-performing teams, fosters psychological safety, and serves as the single point of contact for internal/external customers.

Essential requirements:

• Bachelor's degree in life sciences or healthcare, with an advanced degree preferred.

• Minimum 2 years’ experience in clinical research or drug development in academic or industry environments, spanning Phases I to IV.

• At least 1 year experience conducting global clinical studies including planning, execution, and reporting, in compliance with international standards like GCP/ICH and health authorities' regulations.

• Experience managing teams in a complex, matrix, and global environment, preferably virtual teams.

• Demonstrated ability in building effective relationships with internal and external stakeholders.

• Strong communication and presentation skills, both oral and written.

• Proven organization and prioritization abilities, along with negotiation, conflict resolution, and an enterprise mindset.

• Strong project management skills, strategic thinking, and problem-solving abilities; knowledge of relevant therapeutic area is preferred.

 

Skills Desired

Auditing, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Data Auditing, Data Management, Health Sciences, Lifesciences, Project Planning, Vendor Management, Waterfall Model