MONITOR DE PESQUISA CLÍNICA ESPECIALISTA

Monitor De Pesquisa Clínica Especialista - Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. - 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: oData generated at site are complete, accurate and unbiasedoSubjects 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 and if applicable, RCPM. - Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. - Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. - Supports and/or leads audit/inspection activities as needed. - Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate- Could perform Quality control visits if delegated by other roles and trained appropriate. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. **Required Skills**:- 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 co-monitoring visits where appropriate. **Behavioural Competency Expectations**:- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. - Able to work highly independently across multiple protocols, sites and therapy areas. - High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. - Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. - Demonstrates commitment to Customer focus. - Works with high quality and compliance mind-set. - Positive mindset, growth mindset, capable of working independently and being self-driven. - Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. **Experience Requirements**:Direct site management (monitoring) experience in a bio/pharma/CRO. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicin