莆田招聘

职位描述：
Primary Job Function
Describe in 3-4 short sentences the responsibility and authority of the job.
1. Clinical operational activities for Affiliate sponsored study
2. Key contact person for Global sponsored study
3. Quality Management and Compliance
4. Support business development in New Product Introduction process

Core Job Responsibilities
List the primary tasks and/or activities this job performs on an ongoing basis.
- Affiliate sponsored study:
？ Key internal and external contact person of affiliate sponsored studies to support the project leader
？ To track the study progress in a timely manner, organize regular project review meetings, propose action plan to the project leader, and follow up; to distribute regular study progress report
？ To work with study physician and project leader and Affiliate Safety Representative on essential study documents, coordinate to get approval
？ Key contact with global team to have teleconference, coordinate global approval process
？ Update study information in internal study tracking system, register the study in external website
？ Working with external partner such as CRO project manager on study progress tracking, resource allocation, contract sign, and organize / deliver training to CRO team
？ Responsible for study document archiving and management
？ Quality control activities for specific study such as co-monitoring and site visits
- Global sponsored study: to be coordinator to provide local support and as key contact person
- Quality Management and Compliance
？ Ensure all clinical research activities follow Abbott policy, SOPs, OEC, ICH&GCP and local regulations
？ Interpret SOPs of clinical research activities to internal team and external partners
？ Participate to prepare internal audit or external inspection
？ Involve to develop and implement quality management system on clinical research, such as local SOP, working instruction and internal processes
- Support business development in New Product Introduction process

Minimum Education
Indicate the minimum education level to perform this job.
- Bachelor degree or above in Clinical Medicine, Pharmacy, Biology, Chemistry, Pharmacology or related life sciences

Minimum Experience/Training Required
Indicate the minimum experience and/or training required to perform this job.
- Industry experiences: A minimum of 2 year experience
- Position experiences:
At least 2 years experiences of clinical research
Having experiences in CROs or multinational phamarceutical company
- Language Skills：Fluent English in reading, writing and oral communication, able to lead regular TC with global clinical study team
- Computer Skills: Microsoft Office software
- Certificate Required: GCP training

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