job description
Are you a seasoned Clinical Research Operations Leader ready to drive excellence in a dynamic, high-impact environment? Recruit Lync is seeking a CRU Operations Manager to oversee and optimize clinical research operations in Bali, Indonesia. In this pivotal role, you will lead cross-functional teams, ensure regulatory compliance, and deliver high-quality study outcomes while fostering a culture of innovation and operational efficiency.
As the backbone of our clinical research initiatives, you will collaborate with stakeholders to streamline processes, mitigate risks, and ensure seamless project execution. Your expertise in GCP (Good Clinical Practice), ICH guidelines, and study management will be instrumental in maintaining the highest standards of quality and compliance. This is a unique opportunity to shape the future of clinical research in a rapidly growing market while enjoying the vibrant lifestyle of Bali.
If you are passionate about advancing healthcare through meticulous research operations and thrive in leadership roles, we invite you to apply and be part of a mission-driven team.
Responsibility
- Operational Leadership: Oversee end-to-end clinical research operations, including study startup, execution, and closeout, ensuring adherence to timelines, budgets, and quality standards.
- Compliance & Quality Assurance: Ensure all studies comply with GCP, ICH, and local regulatory requirements, conducting audits and implementing corrective actions as needed.
- Team Management: Lead, mentor, and develop a high-performing team of clinical research professionals, fostering collaboration and continuous improvement.
- Stakeholder Coordination: Liaise with sponsors, investigators, ethics committees, and internal teams to align objectives and resolve operational challenges.
- Process Optimization: Identify inefficiencies in workflows and implement best practices to enhance productivity, cost-effectiveness, and scalability.
- Risk Management: Proactively assess and mitigate risks to study integrity, patient safety, and data quality.
- Reporting & Metrics: Develop and present KPIs, progress reports, and performance dashboards to senior leadership and stakeholders.
- Vendor & Resource Management: Oversee relationships with CROs, labs, and other third-party vendors to ensure service excellence and cost control.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field; Master’s degree or PMP/CRP certification is a plus.
- Experience: Minimum 8+ years in clinical research, with at least 5 years in a managerial role overseeing CRU or site operations.
- Regulatory Knowledge: In-depth understanding of GCP, ICH, FDA, and local regulations (e.g., Indonesian FDA/BPOM).
- Leadership Skills: Proven ability to manage cross-functional teams, with strong communication, negotiation, and conflict-resolution abilities.
- Technical Proficiency: Experience with CTMS (Clinical Trial Management Systems), EDC, and eTMF platforms.
- Analytical Mindset: Strong problem-solving skills with the ability to interpret complex data and drive data-driven decisions.
- Language: Fluency in English; proficiency in Bahasa Indonesia is advantageous.
- Soft Skills: Highly organized, detail-oriented, and adaptable to fast-paced, multicultural environments.