Contract
Country Operations Manager - Czech Republic
Czech Republic
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
  

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LI-Remot

• 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 requeste