Clinical Operations Associate Manager

Title:

Clinical Operations Associate Manager

Company:

Ipsen Korea

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

[Summary]

To lead and oversee the operational execution of global and local clinical studies in Korea, including company-sponsored studies and investigator-sponsored studies, in accordance with Ipsen SOPs, applicable local regulations, ICH-GCP, GPP, GPvP, and internal compliance standards.

The role acts as the local clinical operations lead and serves as the primary local study operations contact for assigned studies, ensuring effective planning, implementation, monitoring oversight, vendor coordination, study budget tracking, study documentation oversight, and timely delivery of clinical study milestones. The position works closely with Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality, Legal, Finance, global/regional Clinical Operations teams, external vendors, study sites, investigators, and other relevant stakeholders.The scope also includes operational leadership of non-interventional studies, PMS, and third-party real-world data generation projects, including common data model and electronic medical record/claims-based analytics, in close collaboration with the Medical Lead and relevant functions.

Main Responsibilities

Clinical study planning and local feasibility

• Lead local operational planning for assigned global and local studies in Korea, including feasibility, site selection, timelines, milestones, budget assumptions, vendor needs, and operational input to study documents.
• Partner with Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality, and global/regional teams to ensure study start-up readiness.

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.

Post-marketing surveillance (PMS) and CRO operational management

• Lead operational coordination with CROs and external providers for PMS and other assigned post-marketing studies, including vendor communication, scope of work, contracting processes, study start-up, timelines, deliverables, issue resolution, and close-out.
• Coordinate PMS execution, status tracking, reporting requirements, and vendor performance with Medical Affairs, Pharmacovigilance, Regulatory Affairs, Quality, Legal, Procurement, and Finance, as applicable.

Third-party real-world evidence and healthcare data generation projects

• Serve as the primary operational point of contact for external healthcare data partners and research service providers conducting RWE, retrospective database studies, and common data model-based data generation and analyses.
• Lead day-to-day partner communication and coordinate feasibility assessments, proposals, statements of work, contract execution, project plans, timelines, budgets, deliverables, data governance requirements, and issue escalation with relevant internal functions.
• Ensure operational delivery and appropriate oversight while Medical Affairs retains ownership of scientific objectives, study methodology, clinical interpretation, and publication decisions.

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.
• Experience coordinating external healthcare data partners, database/RWE projects, and non-interventional or PMS study operations.
• 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.
• Experience or academic background in biostatistics, epidemiology, or pharmacoepidemiology, with knowledge of observational study and RWE methodologies, is preferred.
• Experience with healthcare data sources, other structured datasets, and PMS CRO/vendor coordination is an advantage.

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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