Abbott APAC Clinical Development Operations Director in Singapore, Singapore
APAC Clinical Development Operations:
Plan and execute clinical development strategy for local and regional new product development projects.
Coordinate and give guidance for regional/local clinical studies together with regional/local ClinDevOps or Medical teams in APAC countries
Lead review and approval of clinical development study protocols, reports and ther relevant publications per Abbott EPD Global Clinical Quality System.
Co-lead “interventional Therapeutic Area Review Committee (iTARC)” for reviewing and approving APAC’s local/regional development studies.
Provide oversight of conduct of clinical development projects per Abbott EPD Global Clinical Quality System, and ICH GCP regulations.
Ensure quality conduct of studies through qualified 3th party vendors (CROs, phase I units etc.) per Abbott EPD Global Clinical Quality System, and ICH GCP regulations.
Ensure data accuracy/integrity, and the quality of the study reports per Abbott EPD Global Clinical Quality System, and ICH GCP regulations.
Represent Clinical Development function of APAC in relevant Global Clinical Development Management Team (GCDMT) meetings, and actively participate in decision making process for local/regional development programs of APAC in GCDMT.
Oversee and conduct regional/local interventional clinical studies / real life post-marketing observational data collection schemes, and medical research activities. Delivering their results based on agreed development timelines.
As part of APAC I&D team
Collaborates with other Global / Regional I&D team members in supporting BD, MAKE or other innovation programs as assigned.
Performs other duties as assigned or requested.
An Equal Opportunity Employer
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We provide reasonable accommodation to qualified individuals with disabilities.
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