At AllucentTM, we are dedicated to helping small‐medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life‐changing therapies to patients in need across the globe. Responsibilities * Leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract * Creates and executes project management plans required for project delivery and in accordance with established processes * Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines. * Establishes clear communication lines and escalation pathways, communicates with project stakeholders * Provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report * Establishes requirements for and ensures project specific training plan for team activities * Leads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM)
and Investigator Meetings based on project scope * Provides support for vendor identification, qualification and selection and manages vendors * Manages vendors and vendor relationships as required for project delivery * Ensures effective and efficient resource utilization across projects and programs * Produces, maintains and circulates project progress and status reports * Manages the study budget, including monthly invoicing. * Establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle * Proactively recognizes and addresses any changes in scope * Negotiates and influences internal and external team members in a professional manner and with successful outcomes * Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills * Ensures the Trial Master File is kept up to date and inspection rea
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