Jobs

HUTCHISON MEDI PHARMA CO., LTD. is Hiring

March 6, 2017

药(上海)有

 

POSITION TITLE                    :  Clinical Project Manager

DEPARTMENT                        :  Clinical & Regulatory Department

DIRECTLY REPORTS TO       :  Head of Clinical Operations &Drug Safety

 

PRIMARY FUNCTION

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Ÿ  Management of clinical research project.

 

 

MAJOR RESPONSIBILITIES, AND DUTIES

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Ÿ  Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.

Ÿ  Provide leadership in the conduct of clinical trials, protocol design and implementation, data analysis, management of project progress and timelines.

Ÿ  Input operational part of the protocol for trials.

Ÿ  Review and approve study CRFs.

Ÿ  Prepare Monitoring Manual and ensure it is in agreement with the protocol and SOP.

Ÿ  Contact with CMC department regarding design of labeling, packaging and drug logistics.

Ÿ  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.

Ÿ  Select clinical trial site and keep good relationship with investigators

Ÿ  Initiate and ensure timely submission to Independent Ethics Committee (IEC) and support investigator as necessary.

Ÿ  Select and cooperate with statistician to conduct data analysis when required.

Ÿ  Participate in regular Data Quality Review Meetings.

Ÿ  Coordinate final trial report.

 Ÿ  CRO Selection.

 Ÿ  CRO supervision at the trial level 

SECOND FUNCTION

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Ÿ  Quality control of the clinical research projects, such as comonitoring.

 

 

MAJOR RESPONSIBILITIES, AND DUTIES

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Ÿ  Do co monitoring visits for the project

Ÿ  Review monitoring reports

Ÿ  Check TMF before archiving

 

 

Qualifications

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Ÿ  At least bachelor degree in Clinical Medicine or pharmacy or related major. Mater or MD preferred.

Ÿ  At least 3 years industry experience with proven proficiency in clinical research management for drug development.

Ÿ  Good understanding of ICH guidelines, GCP and regulatory requirements.

Ÿ  Proficiency in English (written and oral) and familiarity with standard IT office tools.

Ÿ  Excellent planning, organization and problem solving abilities

Ÿ  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