Position Title: (Sr.) Clinical Project Manager
Function: Clinical Development
Report to: Clinical Operation Director
Entity: Laekna LLC
This position is under clinical development function and will be responsible for working with cross-functional project teams to effectively drive drug development from clinical perspective and take the lead role in cross function collaboration.
· Select, manage, and serve as the primary point of contact with CRO, vendors and study sites.
· Monitor the quality of CRO/vendor deliverables.
· Support study document development such as protocol, IB and ICF etc.
· Support site management and fully involved in resolving study related issues.
- Support KOL management.
· Study timeline/budget management and clinical trial agreement negotiation.
- Ensure that study milestones and budget are met as plan.
· Smooth cross-functional communication internally and support overall development of clinical studies, evaluate risk and benefit, drive decision made between team and stakeholder.
· Host project meetings, discussions and deliver meeting minutes, track all follow up actions to be done.
· Project related tasks assigned by line manager such as internal process optimization, communication pathway optimization, organize non-project training for clinical development etc.
1.2 years above project management experience, preferably handle study independently. SPM will require 4 years above project management experience.
2.Great communication skill and strong self-motivation to drive things happen.
3.Teamwork spirit and ownerships.
Laekna is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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