The Country Operations Manager (COM) reports directly to our Director, Clinical Site Liaison. The COM will lead and manage the conduct of clinical trials from study start-up to closeout across assigned countries in accordance with ICH-GCP and applicable local regulations. Maintain the quality and scientific integrity of clinical trials at a local/country level and actively collaborate with cross functional internal and external partners to ensure timely delivery, budget execution of clinical trial results within the local country.
Responsibilities & Duties

• Collaborates with other COMs and the Study Lead for global execution of study
• Maintains the quality and integrity of clinical trials across assigned countries
• Collaborates with cross functional internal and external stakeholders to ensure timely and on budget execution of clinical trial deliverables within the region
• Provides regional input operational planning activities
• Manages and reports clinical studies in assigned countries through oversight of study activities, identification and resolution of issues, and communication of study timelines/deliverables to Study Lead
• Ensures implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines
• Ensures relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Supports country-level operational planning and site selection within assigned countries
• Supports and contributes to Study Management Teams (SMTs), agenda driven presence at Study Management Team meetings
• Contributes to site-level goal setting and study-specific deliverables for clinical sites within their assigned countries
• Coordinates cross-functional review of issues escalated directly from sites or via the Clinical Site Liaison, CRA, and facilitates resolution
• Oversees and monitors applicable vendor activities
• Contributes to, delivers, and/or lead CRA, Investigator and Study Coordinator training
• Supports internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g. vendor management
• Contributes to study-level investigational product management
• Responsible for study team deliverables within assigned countries
• Participates in cross-functional task forces/process improvement activities as requested

Qualifications & Skills

• BA/BS/BSc
• 7-years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
• Advanced knowledge of clinical trial management including regulations and guidelines across multiple countries
• Clinical trial processes and operations
• Extensive knowledge of ICH/GCP regulations and guidelines
• Project and Program management including oversight of study deliverables, budgets and timelines
• Key performance indicators (KPIs)
• Fluency in local country language and English

#kpslife
#LI-Remote