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 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.Responsibilities include but are not limited to:- 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 regulations, 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: o Data generated at site are complete, accurate and unbiased. o 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 Escalation Pathway as appropriate in collaboration with leadership as needed.- Works in partnership with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, headquarter functional areas and externally with vendors and Regulatory Authorities in support of assigned sites.- Manages and maintains information and documentation in various other systems as appropriate and per timelines.- Contributes to CRA team knowledge by acting as process Subject Matter Expert, 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 Clinical Research Director and/or Clinical Reseach Associates manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.CORE Competency Expectations:- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.- Demonstrated ability to mentor/lead.- Hands on knowledge of Good Documentation Practices.- Proven Skills in Site Management including independent management of site performance and patient recruitment.- Demonstrated high level of monitoring skill with independent professional judgment.- Ability to understand and analyse data/metrics and act appropriately, also in a virtual environment.- Experience with conducting site motivational visit designed to boost site enrollment.- Capable of managing complex issues, works in a solution-oriented manner.- Performs root cause analysis and implements preventative and corrective action. - Capable of mentoring junior CRAs on process/study requirements and is able to perform comonitoring visits where appropriate.Experience Requirements:- Min. 4Y of direct site management (monitoring) experience in a bio/pharma/CRO.- B.A./B.S. with strong emphasis in science and/or biology**Search Firm Representatives Please Read Carefully****Employee Status**:Regular**Relocation**:No relocation**VISA Sponsorship**:**Travel Requirements**:**Flexible Work Arrangements**:Hybrid**Shift**:**Valid Driving License**:**Hazardous Material(s)**:**Requisition ID**:R284452
