Global Study Manager

About the job

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. significant contributor to our business and our innovation pipeline.

You will be part of the Global Clinical Department and you will represent and support the department at

study level, collaborating actively with all functions in Clinical and for optimized deliverables. The GSM is responsible for providing assumptions for number of sites and enrolment rates for budget and planning purposes for all studies within a program. The GSM is accountable for accurate reporting, study delivery at and to Global Clinical Department upper management.

The GSM coordinates Clinical teams with the Global Clinical Development Strategy Expert (GCDSE) and is accountable for delivering studies with timelines, budget and quality expected. S/he is accountable to develop and maintain optimized study planning with other functions, considering all efficiencies to be gained.

The GSM integrates and follows up study risks, ensuring alignment of all Clinical team members and functions

Overall responsibilities:

• Ensures proper study setup & provides oversight of a study to ensure progress according to study timelines
• Ensures proper setup of Trial Management tools and adequate management of study documentation availability and tool access
• Organizes study specific meetings and collects, synthesizes and reports study information
• Participates in selection and management of vendors and operational experts, development and follow-up of the associated budget when needed
• Accountable for preparation and follow-up of study budget
• Collaborate to the preparation and oversight of study audits/ pre-approval inspections (PAI)/inspections

About you

• Bachelor of Science or equivalent.
• Minimum 6 years’ experience in in vaccinology or clinical research.
• Formal training in GCP methodology and proven record in delivering high quality GCP- compliant clinical trials.
• Prior project/ budget management experience.
• Knowledge of Code of Federal Regulations (US) and other regulatory agency documents.
• Proficient in both verbal and written English and Thai
• Demonstrated interpersonal and ability to collaborate well across function
• Results- oriented and resourcefulness, ability to find solutions to operational problems
• Team player with positive mindset and behaviors
• Demonstrated advanced team and negotiation skills