Clinical Operations Associate Manager

Implementation and oversight of clinical studies

• Oversee study start-up, conduct, monitoring follow-up, enrollment progress, issue escalation, CAPA/mitigation actions, and close-out to deliver study milestones on time.
• Coordinate required study documents and serve as a key local operational contact for study sites, vendors, IRBs/IECs, authorities, and internal stakeholders.

Vendor, CRO, CRA and site oversight

• Oversee vendors, CROs, CRAs, consultants, study sites, and service providers against agreed milestones, deliverables, quality expectations, and contractual obligations.
• Support vendor/site selection, financial agreement processes, and monitoring oversight in collaboration with Medical Affairs, Procurement, Legal, Quality, Finance, and other relevant teams.

Study budget, contract and resource management

• Develop, track, and monitor study budgets, costs, resources, timelines, contracts, payments, and operational deliverables, escalating significant risks or discrepancies as needed.

Study documentation, systems and quality compliance

• Ensure study documentation, CTMS/system updates, milestone tracking, and essential documents are accurate, complete, timely, and inspection ready.
• Maintain compliance with Ipsen SOPs, ICH-GCP, GPP, GPvP, and local regulatory requirements, and support audits, inspections, quality reviews, and follow-up actions.

IMP and study material coordination

• Coordinate IMP, trial materials, and study supplies planning, forecasting, supply, handling, reconciliation, and documentation with global/regional supply chain and relevant stakeholders.

Cross-functional collaboration and governance

• Serve as local clinical operations lead, ensuring effective communication, governance updates, decision support, and timely escalation of study risks, issues, resource constraints, and timeline delays.
• Drive alignment across Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality, Legal, Finance, Procurement, global/regional Clinical Operations, and external partners.

Local clinical operations capability

• Strengthen local clinical operations capability by supporting onboarding, training coordination, system access.

Technical Competencies

• Clinical project management and execution oversight across the study lifecycle.
• Ability to identify, assess, escalate, and mitigate operational risks impacting timelines, quality, budget, or compliance.
• Vendor, CRO, and service provider oversight to ensure delivery against contractual obligations and study objectives.
• Strong understanding of clinical quality systems, inspection readiness, audit support, and CAPA management.
• Effective stakeholder management and cross-functional collaboration in a matrix environment.
• Working knowledge of CTMS and clinical documentation management practices.

Knowledge & Experience:

• Minimum 5 years of overall professional experience, including at least 3 years of relevant experience in clinical operations, clinical trial management, clinical project management, or related clinical research roles.
• Experience managing or supporting global and/or local clinical studies from planning through study close-out.
• Experience working with CROs, investigators, study sites, and external vendors.
• Knowledge of Korean clinical trial regulations, ICH-GCP, and related compliance requirements.
• Experience supporting inspections, audits, quality reviews, or compliance-related activities

Knowledge & Experience (preferred):

• Experience with both company-sponsored studies and investigator-sponsored studies in Korea.
• Experience working in a matrix, regional, or global clinical operations environment.
• Experience in specialty care, oncology, rare disease, or other complex therapeutic areas.

Education / Certifications:

• Bachelor’s degree in life sciences, pharmacy, nursing, public health, clinical research, or a related scientific/healthcare discipline.

Education / Certifications (preferred):

• Advanced degree or professional training/certification in clinical research, GCP, project management, regulatory affairs, or quality management.

Language(s):

• Fluent Korean and business-level English, with the ability to communicate effectively with local stakeholders and global/regional teams.
• Additional language capability relevant to regional or global collaboration is an advantage.

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