31 Oct
|
Sanofi Group
|
Woolloongabba
31 Oct
Sanofi Group
Woolloongabba
Woolloongabba Full time R2875555 **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 productive 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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t;=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! 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 (https://youtu.be/96EwNjb1TLo) 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.
📌 Global Study Manager - TSH (Woolloongabba)
🏢 Sanofi Group
📍 Woolloongabba