Clinical Research Monitor / CRA / Project Manager

As a Clinical Research Monitor / CRA / Site Monitor, your role involves coordinating clinical studies and taking responsibility for study execution, monitoring, site training, and close-out. You will have the following key responsibilities: - Managing the execution of clinical trial projects from initiation to closeout across multiple projects, sites, and teams. - Managing site relationships to ensure compliance with regulations, budgets, and timelines. - Providing operational insights to ensure compliance with Protocol, SOPs, policies, and practices. - Collaborating with project teams and sponsors. - Handling site qualification, contract negotiation, IRB/EC submissions, study initiation, monitoring, and site close-out. - Providing training and oversight to site staff. - Conducting periodic reviews of site-level KRIs. - Early identification and escalation of site-level risks/issues during study conduct. - Maintaining the Trial Master File (TMF). - Coordinating study supplies, biospecimen management, and stakeholder coordination. - Resolving data queries. - Supporting audit readiness and preparations. - Preparing study progress and performance metrics. - Traveling to investigative sites (up to 25% of the time). Desired Candidate Profile: - Rich experience in clinical research operations and project management, preferably in global clinical trials. - A degree in medicine, pharmacy, or life sciences. - In-depth understanding of clinical research regulations, industry standards, and GCP. - Excellent verbal and written communication skills. - Proficiency in using MS Word & MS Excel. This is a full-time position with a day shift schedule. The work location is in person.,