Direct message the job poster from ODC Life Sciences
Position Mission:
Responsible for developing detailed clinical research project plans and solving problems throughout all phases—from initiation, follow-up, to completion—aligning with client expectations.
Main Responsibilities:
- Manage the entire project cycle: resources, schedule, quality standards, issues, risks, and changes to ensure successful delivery within budget and meeting expected results;
- Plan, implement, and monitor the project's progress, communicating appropriately with involved areas at each phase or activity;
- Ensure all actions comply with international, national, and good clinical practice guidelines, striving for excellence in execution, conduct, and management;
- Create, maintain, and share project planning and progress spreadsheets among all stakeholders, including regulatory, import/export, laboratory, clinical operations, financial, and legal teams;
- Lead, motivate, and mentor project team members to perform effectively and achieve goals;
- Coordinate team schedules aligned with the sponsor’s objectives;
- Monitor activities and organize information flow from CMSLs to the sponsor;
- Develop strategies to engage key opinion leaders through visits, meetings, and information sharing to ensure protocol adherence and motivation;
- Identify new regulatory opportunities;
- Recruit new research centers, conduct meetings with KOLs, manage relationships, and oversee documentation related to study responsibilities;
- Manage regulatory submissions with country experts, review timelines, and prepare documentation for drug dossiers and protocol submissions;
- Assess trial feasibility and coordinate its execution to meet KPIs;
- Supervise CRO activities to ensure compliance with protocols and regulations.
Academic Background:
- Healthcare, Business Administration, Engineering, or related fields;
- Post-graduation in Health, Projects, or relevant areas is desirable.
Language Requirement:
- Advanced English proficiency
Experience:
- Minimum of 3 years in project management within Clinical Research
Seniority Level:
Employment Type:
Job Function:
- Finance, Management, and Project Management
Industries:
- Pharmaceutical Manufacturing, Hospitals and Healthcare, Research Services