Clinical Study Manager

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The Position

The Clinical Study Manager provides strategic support and operational execution for clinical trials in collaboration with the Country Clinical Operations Lead/Clinical Study lead. This role encompasses supporting the local strategic planning and organizational skills to ensure the delivery of clinical trials in accordance with quality standards, ICH/GCP, Roche SOPs, local operating guidelines, and regulatory requirements. Additionally, the Clinical Study Manager contributes to evidence generation initiatives, including publications, real-world evidence (RWE), and data generation, while supporting compassionate use and post-trial access programs. The role focuses on the leadership or execution of a combination of Investigator Initiated Studies (IIS) and managed secondary data use RWE activities, or the country management of global studies, ensuring effective and efficient delivery in accordance with ICH/GCP and GVPs/GPPs quality standards.

As a Clinical Study Manager you will be a core member of the Malaysia Clinical Operations Team that is part of the Medical, Innovation & Regulatory Chapter.

The Opportunity

• Builds efficient study teams and ensures team members are aware of their accountabilities, responsibilities, and deliverables
• Supports the Country Clinical Operations Lead/Clinical Study Lead in the day-to-day execution and delivery of clinical trials, ensuring adherence to study timelines, budgets, and quality standards
• Coordinates study-related activities, including site management, monitoring, data management, and regulatory submissions, under the guidance of the Country Clinical Operations Lead
• Oversees the maintenance of drug supplies and resolution of issues with input from the Clinical Drug Supply coordinator for both clinical trials, Compassionate Use Program, and Post Trial Access Program
• Accountable for vendor study deliverables according to timelines, budget, operational procedures, quality/compliance, and performance standards including study-level patient recruitment plans and retention strategies. Identifies systematic issues and coordinates any corrective action. Ensures vendors receive appropriate training of quality insurance inclusive of the FSP program
• Supports the Country Clinical Operations Lead in building and maintaining relationships with external stakeholders, contributing to strategic planning, and process optimization initiatives
• Supports the identification of evidence generation gaps and contributes to the development of strategies to address these needs
• Contributes to publication efforts, real-world evidence initiatives, and compassionate use/post-trial access programs under the guidance of the Country Clinical Operations Lead. Accountable for the tracking of HA and EC approvals, as applicable
  
  
  

Who You Are

• University degree or equivalent; professional qualification strongly preferred in a medical/science-related field
• Extensive experience (minimum 5 years) and expertise in clinical research/development or related industry and clear understanding and experience applying ICH/GCP and/or GVP/GPPs and applicable regulations including awareness of quality requirements.
• Experience working as part of a team with a proven ability to lead and contribute to the team’s performance and teamwork
• Proven project management experience especially in clinical trials and organizational skills and the ability to prioritize and manage multiple tasks flexibly. Proven strategic capabilities, leadership skills, organizational awareness, and proactive planning with embedded contingencies and a risk management mindset
• Borderless Collaboration: working closely with other countries/communities/teams. Proven stakeholder management skills
  
  

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.