Associate Director, Risk-Based Quality Strategy is responsible for leading and overseeing the planning and execution of Risk-Based Quality Management (RBQM) strategies for clinical trials. This role focuses on ensuring that RBQM efforts are effectively targeted to areas of highest risk, optimizing resource allocation, and enhancing the quality and compliance of clinical trials.

This opportunity will be based in ANZ, US, Taiwan, Malaysia, Korea, Singapore or Hong Kong.

Responsibilities:

Strategic Planning and Implementation:

• Planning and implementing RBQM / RBM strategies and methodologies.
• Create comprehensive operational plans for risk-based monitoring, emphasizing risk assessment and mitigation.
• Review the project Integrated Quality Risk Management Plan (IQRMP) and Clinical Management Plan (CMP) to ensure they adequately reflect the RBQM/RBM strategy.

Business Development support:

• Attend Bid-Defence meeting to present RBQM strategy.
• Support RBQM lead and project team (Project manager and Clinical lead) to create a Risk-Based Monitoring plan.
• Review the monitoring budget and/or proposal document to ensure it appropriately reflects the RBM strategy if required.

Risk Assessment and Management:

• Provide guidance to PM/CL and RBQM lead to identify and evaluate potential risks in clinical trials using data-driven approaches.

Stakeholder Communication and Collaboration:

• Serve as the primary point of contact for RBQM strategy-related matters with internal and external stakeholders.

Minimum Qualifications & Experience:

• Bachelor’s degree or higher in life sciences, medicine, pharmacy, nursing, or a related field. Advanced degrees (e.g., Master’s, Ph.D.) are preferred.
• Minimum of 10 years of experience in clinical trial monitoring or project management, with at least 3 years in a leadership role focused on RBQM / RBM (Risk-Based Monitoring).
• Experience with multinational clinical trials and familiarity with advanced monitoring technologies and software.
• Extensive understanding of GCP, ICH guidelines, and regulatory requirements related to clinical trials.
• Ability to manage multiple communication stream.
• Demonstrate the leadership in the cross-function work.
• Good interpersonal skill allowing professional communication with all levels of the organizations.
• Ability to identify risk and trends. Data analysis and technical skills in clinical trials/clinical data are preferred.
• Strong project management and problem solving skills.
• Fluent communication of speaking and writing in English.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.