• The role is accountable for performance and compliance for assigned protocols and sites in a country. • Under the oversight of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. • Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. • Actively develops and expands the territory for clinical research, finding and developing new sites. • Participates in internal meetings and workstreams as SME for monitoring processes and Systems. • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gains an in-depth understanding of the study protocol and related procedures. • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. • Participates & provides inputs on site selection and validation activities. • Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. • Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. • Supports and/or leads audit/inspection activities as needed. • Performs co-monitoring visits where appropriate. • Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

• accountable for performance and compliance for assigned protocols and sites • ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures • acts as primary site contact and site manager throughout all phases of a clinical research study • develops and expands the territory for clinical research, finding and developing new sites • performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents • conducts site visits and maintains clear, comprehensive and accurate visit & non-visit contact reports • communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, regulatory documentation, site audits/inspections • identifies, assesses and resolves site performance, quality or compliance problems

• The role is accountable for performance and compliance for assigned protocols and sites in a country. • Under the oversight of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. • Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. • Actively develops and expands the territory for clinical research, finding and developing new sites. • Performs remote and on-site monitoring & oversight activities to ensure: • Data generated at site are complete, accurate and unbiased. • Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gains an in-depth understanding of the study protocol and related procedures. • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. • Participates & provides inputs on site selection and validation activities. • Performs remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. • Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.