Global Study Manager - TSH

(2112) Sanofi-Aventis Australia Pty Limited; Brisbane; On-site; AUD 150,000 - 190,000; Full time

Job summary

Sanofi invites applications for a Global Study Manager within the Translational Science Hub. Based in Woolloongabba, AUS, the role oversees operational delivery of vaccine studies, aligning with Clinical Operations leadership to optimize study design, timelines, and budgets.

The successful candidate will coordinate cross-functional teams, manage CROs and vendor partnerships, and drive feasibility assessments and risk management across global sites.

Qualifications

• Bachelor's degree in a relevant field.
• Formal training in GCP.
• 6+ years of clinical research experience, preferably in vaccines.
• Clinical trial experience, including vaccine trials.
• Proven track record delivering high-quality, GCP-compliant trials.
• Project and budget management experience.
• Experience working with CROs on full-service clinical trials.
• Advanced teamwork and negotiation skills; global experience.

Responsibilities

• Study design input to ensure operational considerations are built into study design.
• Coordinate the Clinical Team with multidisciplinary platforms for all operational aspects.
• Conduct feasibility assessments with inputs from RA timelines, country selection, recruitment potential, and budget needs.
• Develop and maintain optimized study plans and enrollment assumptions for budgeting.
• Manage CROs for the operational delivery of studies.
• Develop clinical trial networks and vendor partnerships for the program.
• Collaborate with the Head of Clinical Operations to build trial capacity.
• Engage with external partners, sites, and investigators.

Skills

GCP training

Clinical research experience

Project management

Budget management

Global collaboration

CRO coordination

Cross-functional leadership

Education

Bachelor's degree in a relevant scientific field

Job description

Job Title: Global Study Manager – TSH

Location: Woolloongabba, AUS

Job Type: Permanent, Full Time

About the Job

The Global Study Manager is a key role within the Clinical Team, responsible for the operational delivery of all studies within a specific project of the Translational Science Hub (TSH). The role is accountable for delivering studies on time, within budget and to the required quality standards. Working closely with the Head of Clinical Operations, the Global Study Manager creates synergies across studies and proposes innovative approaches to study operationalization.

Key Responsibilities

• Study design input: Work with the Clinical Team to ensure operational considerations are built into an efficient study design.
• Cross-functional coordination: Coordinate the Clinical Team with representatives from Global Clinical Department platforms, GCI, GPV, RA, Clinical Supply Chain and other relevant departments on all operational aspects of the study.
• Feasibility and risk management: Ensure study feasibility assessments are completed with input from other functions (RA timelines, country selection, recruitment potential, budget needs). Integrate the findings into the study plan and risk log and follow up on risks to keep all Clinical Team members and functions aligned.
• Planning and budget assumptions: Develop and maintain optimized study plans with other functions. Provide assumptions on the number of sites and enrollment rates for budget and planning purposes across all studies in the program.
• Vendor and CRO management: Work with CROs on the operational delivery of studies.
• Network and partnership development: Develop clinical trial networks and vendor partnerships for the program through the TSH.
• Interactions Internal: Members of the Clinical Team, including the Global Clinical Development Strategic Expert and the Global Biostatistician. The role works closely with the Head of Clinical Operations to build the TSH's clinical trial capacity.
• External: Clinical Research Organizations, external partners, sites and investigators.

Requirements Qualifications

• Bachelor's degree in a relevant scientific field, or equivalent qualification
• Formal training in GCP
• Experience 6+ years of experience in clinical research, preferably in vaccines
• Clinical trial experience (required), including experience in vaccine trials
• Proven track record of delivering high-quality, GCP-compliant clinical trials
• Project management and budget management experience
• Desirable
• Experience working with CROs on full-service clinical trials
• Advanced team-working and negotiation skills
• Experience working in a global environment with multicultural teams

Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.