HUTCHISON MEDI PHARMA CO., LTD. is Hiring
和 记 黄 埔 医 药（上海）有 限 公 司
POSITION TITLE : Clinical Project Manager
DEPARTMENT : Clinical & Regulatory Department
DIRECTLY REPORTS TO : Head of Clinical Operations &Drug Safety
PRIMARY FUNCTION
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Management of clinical research project.
MAJOR RESPONSIBILITIES, AND DUTIES
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Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.
Provide leadership in the conduct of clinical trials, protocol design and implementation, data analysis, management of project progress and timelines.
Input operational part of the protocol for trials.
Review and approve study CRFs.
Prepare Monitoring Manual and ensure it is in agreement with the protocol and SOP.
Contact with CMC department regarding design of labeling, packaging and drug logistics.
Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and current issues. Records of training should be maintained.
Select clinical trial site and keep good relationship with investigators
Initiate and ensure timely submission to Independent Ethics Committee (IEC) and support investigator as necessary.
Select and cooperate with statistician to conduct data analysis when required.
Participate in regular Data Quality Review Meetings.
Coordinate final trial report.
CRO Selection.
CRO supervision at the trial level
SECOND FUNCTION
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Quality control of the clinical research projects, such as comonitoring.
MAJOR RESPONSIBILITIES, AND DUTIES
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Do co monitoring visits for the project
Review monitoring reports
Check TMF before archiving
Qualifications
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At least bachelor degree in Clinical Medicine or pharmacy or related major. Mater or MD preferred.
At least 3 years industry experience with proven proficiency in clinical research management for drug development.
Good understanding of ICH guidelines, GCP and regulatory requirements.
Proficiency in English (written and oral) and familiarity with standard IT office tools.
Excellent planning, organization and problem solving abilities
Good communication and interpersonal skills
Internal-External Relations
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Internal: staffs in C&R department, CMC department and DMPK department
External: Investigators and other relevant persons in hospitals or institutes, vendors
