03 ago
|
Indero
|
Buenos Aires
03 ago
Indero
Buenos Aires
The project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Project Manager II acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline)
This role will be perfect for you if:
You want to work for a mid-sized CRO that works on significant multisite trials, including General Phase III projects
You are looking to position yourself in an environment where you can grow your career alongside the company
IMPACT AND RESPONSIBILITIES
Client interactions
Serve as primary contact for the Sponsor
Provide efficient and timely updates on trial progress
Lead client calls effectively
Project planning
Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
Participate in the planning and conduct of the Investigator’s Meeting.
Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
Lead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.
Collaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study.
Partner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and
📌 Project Manager II (Buenos Aires)
🏢 Indero
📍 Buenos Aires