Global Study Manager - TSH

Sanofi; Brisbane; On-site; AUD 140,000 - 190,000; Full time

Job summary

Sanofi Group is seeking a Global Study Manager for the Translational Science Hub (TSH) in Woolloongabba, AUS. This permanent, full-time role leads the operational delivery of studies, working with the Head of Clinical Operations to ensure timely, on-budget, high-quality execution across the program.

Key responsibilities include study design input, cross-functional coordination, feasibility and risk assessment, and budget planning.

Qualifications

• Bachelor's degree in a relevant scientific field is required.
• Formal training in GCP is required.
• 6+ years of experience in clinical research, preferably vaccines.
• Clinical trial experience including vaccine trials is required.

Responsibilities

• Study design input: ensure operational considerations are built into study design.
• Cross-functional coordination with Global Clinical Department platforms, GCI, GPV, RA, Clinical Supply Chain and other functions.
• Feasibility and risk management with input from RA timelines, country selection, recruitment potential and budget needs.
• Planning and budget assumptions: develop optimized study plans with other functions and provide site/enrollment rate assumptions.
• Vendor and CRO management: work with CROs on operational delivery of studies.
• Network and partnership development: build clinical trial networks and vendor partnerships through the TSH.

Skills

Project management

Budget management

Cross-functional collaboration

Vendor management

GCP familiarity

Education

Bachelor's degree in a relevant scientific field

Formal training in GCP

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