At Allucent™, 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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