Description

In this role, you will play a vital part in coordinating clinical study activities, ensuring quality and timeliness from start to finish. Your day-to-day responsibilities will involve managing documentation, collaborating with various teams, and supporting the local study team in achieving their goals.

Requirements

• •Bachelor's Degree in a related discipline
• •Proficiency with MS Office Suite
• •Understanding of the drug development process
• •Minimum experience of 3 years in Development
• •Excellent collaboration and interpersonal skills
• •Strong organizational skills
• •Strong attention to detail
• •Effective written and verbal communication skills
• •Prior experience working in clinical research
• •Medical knowledge and ability to learn relevant areas
• •Ability to work in a remote environment
• •Positive approach to change management
• •Championing efficient methods for clinical trials
• •Team oriented and flexible
• •Understanding impact of technology on projects

Tasks

• •Support the local study team in achieving quality and timely study deliverables
• •Set up and maintain the electronic Trial Master File (eTMF)
• •Track regulatory documents and team training documentation
• •Manage milestones in the Clinical Trial Management System (CTMS)
• •Assist with start-up activities, including CDA delivery and negotiation
• •Distribute and collect documents during contract negotiation
• •Prepare Site Files and obtain site activation approvals
• •Collaborate with PMCO, CRAs, SSU manager, and study vendors
• •Act as a central point of contact for project communications and documentation
• •Contribute to the development and maintenance of project management tools
• •Collaborate on global initiatives to standardize processes
• •Assist with local language translations and submissions to IRB/CEC/CA
• •Support local COM team with face-to-face study and team meetings
• •Assist with team teleconferences and staff onboarding

Tools & Technologies