Job Description
The **Local Study Project Manager** leads Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with IQVIA or Sponsor Procedural Documents and International guidelines such as ICF-GCP as well as relevant local regulations.
Responsible to ensure the sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived, to ensure site activation, initiation and maintenance of regulatory activities for selected studies, to perform oversight of local regulatory and ethics submission packages, to oversee milestones planning and strategy for study submission, to oversee the study budget.
**Main Responsibilities**
• Leads Local Study Team consisting of CRAs and Study Start Up Specialists for assigned studies. Ensures, as required, the clinical and operational feasibility assessment of potential studies is performed to the hi...
Responsible to ensure the sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived, to ensure site activation, initiation and maintenance of regulatory activities for selected studies, to perform oversight of local regulatory and ethics submission packages, to oversee milestones planning and strategy for study submission, to oversee the study budget.
**Main Responsibilities**
• Leads Local Study Team consisting of CRAs and Study Start Up Specialists for assigned studies. Ensures, as required, the clinical and operational feasibility assessment of potential studies is performed to the hi...