Manage and coordinate assigned clinical projects
Manage all project specific services required by the Sponsor
Manage the correct development of the clinical project, interacting with the Sponsor and Investigators
Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned
Knowledgeable in the application process for clinical studies
Collect and manage study data documentation
May act as a Technical Specialist supervising projects within specific therapeutic and technical areas
Assure the proper timelines of the assigned projects
Manage the budget for the project
Monitor workload and performance of project team
Plan and monitor the tasks of the team
Coordinate Clinical Research Associates and Clinical Monitors activity
Collaborate with Clinical Trial Administrators and Clinical Research Associates
Collaborate in overall management of the project with the assigned Biometrics team
Collaborate with CTAs in archiving activities
Assist Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports

Bachelor's Degree or equivalent in scientific and/or medical disciplines; Nursing degree or relevant background preferred
Eight (8) years of clinical research experience in Project Management
Previous experience managing oncology and respiratory studies is required
Previous CRA experience is highly desirable
Previous CRO experience is required
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
Prior experience in electronic data capture preferred
Fluent in English
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)

Senior Clinical Project Manager

Key skills