clinical project manager岗位职责

-Forecast timelines, budget & FTE resource ( if applicable).
-Take a key leadership role in the management of studies’ timeline, quality, cost.
-Ensures all activities must be in compliance with SOPs, applicable policies related standards, in line with GxP, local laws regulations.
-Monthly track manage the agreed studies’ timelines, budget resource, highlight significant variance take appropriate actions to get studies on track.
-study information VCV, Evidence Connect system, Medical Tracking system, to global & regional team to ensure up-to-date information captured .
-Timely projects information to the BrTeam.
-Review approve project relevant documents.
-Lead preparation delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans forms, etc.)
-Prepare lead investigatmonitmeeting.
-Ensure AEs/SAE reporting according to GCP regulation.
-Plan lead activities associated with study level Quality Control plan.
-Develop & manage contingency risk plans to assure timely delivery to quality, budget, time escalate issues to stakeholders as appropriate.
-Provide operational support to the ESR investigators to ensure the on time delivery of ESR

-Forecast timelines, budget & FTE resource ( if applicable).
-Take a key leadership role in the management of studies’ timeline, quality, cost.
-Ensures all activities must be in compliance with SOPs, applicable policies related standards, in line with GxP, local laws regulations.
-Monthly track manage the agreed studies’ timelines, budget resource, highlight significant variance take appropriate actions to get studies on track.
-study information VCV, Evidence Connect system, Medical Tracking system, to global & regional team to ensure up-to-date information captured .
-Timely projects information to the BrTeam.
-Review approve project relevant documents.
-Lead preparation delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans forms, etc.)
-Prepare lead investigatmonitmeeting.
-Ensure AEs/SAE reporting according to GCP regulation.
-Plan lead activities associated with study level Quality Control plan.
-Develop & manage contingency risk plans to assure timely delivery to quality, budget, time escalate issues to stakeholders as appropriate.
-Provide operational support to the ESR investigators to ensure the on time delivery of ESR

Job requirements
History of successful managerial experience on projects
● Demonstrate a proven history of successful managerial experience in clinical trials.
● Effectively lead team in the execution of clinical studies to maximize the value of clinical studies
Results driven behavior
● Always maintain a focus on the objectives anticipated outcomes of the clinical trial, ensuring that all components are effectively advanced to meet the established goals.
● Adapt work strategies plans with flexibility in response to trial progress feedback on outcomes. Enhance the trial process to improve both efficiency quality.
Establish robust alliances with both internal external stakeholders
● Establish maintain close collaborative relationships with internal team members. Foster effective communication collaboration among team members to facilitate the smooth progression of the trial.
● Ensure consistent communication coordination with external stakeholders.
● Exhibit good teamwork coordination skills in cross-departmental inter-institutional collaborations.
Self-motivation adaptability
● Demonstrate a robust sense of self-motivation, exhibiting the capacity to actively enthusiastically engage in clinical trial work. Be able to swiftly adapt to devise effective solutions fthe complex dynamic situations, as well as unforeseen challenges encountered in clinical trials, while ensuring continuity stability in work processes.
● Demonstrate a commitment to continuous learning skill acquisition to adapt to the ever-evolving landscape of clinical trial regulations technologies.
Academic / Professional Qualification
● Bachelhigher degree in Science, Medical Pharmaceutical Background