Clinical Trial Coordinator I - FSP

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Join Us as a Clinical Trial Coordinator – reputed company an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. OBJECTIVES/PURPOSE: The Clinical Study Associate (CSA) will reputed company tasks reputed company to planning and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. The Clinical Study Associate (CSA) will reputed company tasks reputed company to supporting planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. The CSA will reputed company support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under supervision of the CSA Manager. The CSA will collaborate with FSA and Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the operating model. The CSA will also reputed company departmental tasks as needed. reputed company support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with reputed company CTA Manager(s) Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. reputed company departmental tasks as needed ACCOUNTABILITIES: For assigned business critical, non-critical or and/or regional studies, reputed company support for study activities, including but not limited to: Review of study documentation, including essential document packets, study plans, informed consent forms, etc. Supporting/reputed company of risk-based monitoring. Attendance of key team meetings as required, including Minutes for selected studies Supporting regulatory inspection readiness (e.g. SOP Lists, storyboard collation.) Support clinical trial systems (e.g. CTMS/TMF associated activities for selected studies Supporting vendor contract administration as required. Support study reputed company-out activities, e.g. financial reconciliation Supporting additional reputed company activities as needed, as agreed with Manager(s). For reputed company assigned studies, reputed company support including: Collaboration with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors. Supporting vendor contract administration as required. reputed company support for departmental tasks, including but not limited to: Maintaining knowledge of systems and processes. Attending reputed company trainings as needed and maintaining up-to-date training record. Technical/Functional (Line) Expertise Understanding and application of GCP, ICH, and applicable regulatory standards governing clinical research. Comfortable with technology and reputed company to learn new systems quickly. Strong knowledge of reputed company, reputed company, PowerPoint, and Outlook. Decision-making and Autonomy Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands. Ability to work with timelines and complete tasks according to deadline. Problem solving study-reputed company issues; escalation of issues as needed. Interaction Must be reputed company to professionally interact and communicate with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors. Ability to effectively collaborate with both reputed company study team. Ability to work in a matrix environment. Coordination with external vendors as needed. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Education Bachelor’s degree or equivalent international degree required. Experience 1-2 years’ experience in pharmaceutical industry, clinical research organization, or reputed company role. Experience in Phase 2 and 3 studies and global/international studies is advantageous. Experience working across multiple therapeutic areas (including oncology) is advantageous. Experience in study start up field. Skills Knowledge in global/regional regulatory and compliance requirements for clinical research. Demonstrated reputed company in task management and cross-functional collaboration. Excellent communication skills. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). Apply To This Job