Job Description:

a) Plans and executes study level project management activities for assigned studies including study level timelines, risk assessment, mitigation plans, and other aspects of study level project management (e.g. budget, metrics).

b) Develop and get alignment with internal senior management team and cross-function team and external partners on milestone dates and tracks overall timeline to ensure delivery throughout the whole study.

c) Closely monitor the status of ongoing projects. Identifies potential issues, risks in a timely manner that may affect the critical path of the clinical study and project milestones.  including vendor selection, site selection, study start up, patient enrollment, date base lock, site closure, study inspection. etc.

d) Ensures quality compliance at the study level to achieve study /country /site level compliance, as appropriate. Ensure appropriate regulatory requirement, GCP/SOP compliance.

e) Work as the key point of contact between internal and external clinical research partner at the study level, maintain relationships with different cooperation partners. 

f) Oversight the performance of 3rd party venders, including but not limited to CRO/SMO/central lab/central imaging/PRO ects throughout whole study.

g) Dynamically reviews study team resource, provides timely actions in order to keep reliable staffing resource strategy.

h) Develops/provides/supports study related training to study team, as appropriate.

i) Obtains clinical study cost forecasts. Establishes and monitors the study budget.

j) Maintains and archives at study level documentation.k)Other appropriate responsibilities assigned by line manager.

Qualifications:

1) Bachelor's degree in a scientific or health care related field, e.g clinical medicine, nursing, biological Sciences etc.

2) Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, FDA/NMPA regulations.

3) Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with internal and external cross-functional teams and individuals.

4) Excellent verbal and written communication skills. Good at oral and writing English.

5) Excellent office computer skills, including experience with clinical databases.

6) Effective cross-functional team player with ability to work in a team environment.

7) Demonstrated leadership skills and strong result driving.

8) Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities; with a high tolerance for ambiguity.

9) Experienced in serving on product development teams and understands the product development lifecycle.