Remote Study Start-Up Manager

Jobgether

1d•Remote

About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Remote Study Start-Up Manager. This role is crucial in overseeing study planning and start-up activities for various projects, ensuring compliance with client processes and regulatory requirements. The Study Start-Up Manager will work closely with a global study team and local stakeholders to guarantee timely activation deliverables. Your leadership will greatly impact project success and contribute to the advancement of clinical development efforts in diverse regions.

Requirements

Minimum 5 years of experience in clinical operations, focusing on project management.
Ability to lead in a matrix environment without direct reports.
Understanding of clinical drug development, especially trial set-up and execution.
Strong project management skills with problem-solving capabilities.
Knowledge of international standards (GCP/ICH) and health authority regulations.
Strong interpersonal, negotiation, and conflict resolution skills.
Effective communication in a local/global matrix environment.

Responsibilities

Supports country SSU strategy in collaboration with the Study Start-Up Team Lead.
Collaborates with Portfolio Team Leads and global study team to meet SSU timelines.
Accountable for timely start-up activities from country allocation until the Green Light milestone.
Ensures compliance with local IRBs/IECs and Health Authorities.
Prepares and finalizes local submission packages for IRB/IEC and Health Authorities.
Coordinates timely responses to deficiency letters with stakeholders.
Manages country TMF documents to ensure inspection readiness.
Implements efficient processes aligning with client strategy.
Leads site selection and oversees local vendor performance.
Ensures sites are ready for âGreen Lightâ and documentation is in place.