锦鲤求职岗位描述
Position Summary:
职位概述：
•As Co- Lead of CST, accountable for all aspects deliverables on time, on quality and within budget in assigned clinical studies from protocol development through effective study execution, reporting and close-out
•Responsible for all Clinical Operations deliverables in assigned clinical studies.
•Contribute to ongoing process improvement initiatives within Clinical Operations
Study management
⚫Together with Medical Lead to establish Clinical Study Team (CST) by requesting cross-function resources and kickoff the CST once the study concept is available
⚫Lead and coordinate study set up with internal cross-function, including medical, DM, Stats, PV, RA, Pre-clinical reps, as well as vendors including CRO, central labs, etc. Work closely with external stakeholders to identify project issues and risks, then resolve or escalate as needed
⚫Develop study overall execution strategy, including but not limited to resource allocation request, study outsourcing model, budget, high level and detail timeline etc
⚫Facilitates the process for core study documents development, like protocol, DMP, safety review plan, medical review etc and providing inputs from clinical operations perspective
⚫Communicate study progress and escalate issues to senior management team and other key stakeholders, as required
⚫Develop core study materials like ICF, patient information cards etc
⚫Develop study level/country level enrollment plan and strategy with critical inputs from Field Site Leaders and ensure study enrolment on target
⚫Develop study vendor oversight plan, specific risk/issue management plan including delivery and quality, etc
⚫Develop study management plan, monitoring plan, QC plan, deviation and issue review plan, etc together with stakeholders
⚫Develop study training plan and ensure study-specific training to study team or external stakeholders is timely and appropriate
⚫Lead and coordinate investigator meetings by collaborating with internal & external team
⚫Support study related committees’ setup, e.g. Safety Monitoring Committee (SMC), Steering Committee (SC), DMC (Data Monitoring Committee) etc and facilitate meetings as planned in charters
⚫Lead audit responses and action plans development for issues relating to subject safety, quality
⚫Lead study team to close the study and sites as planned following SOPs and business needs
⚫Set up study TMF following the SOP and study specifications and ensure good documentation and inspection readiness through the study conduct
Country& Site management:
⚫Set up and manage country start up initiation milestones and enrollment forecasts at country level
⚫Lead Clinical site monitoring team and CTA to work with clinical sites to ensure high quality data collected/cleaned and good documentation at site level.
⚫Ensure study-specific training to local CRA team or CRO counterparts is appropriate.
⚫Lead study teams (Clinical site monitoring team, CTA) or work with CRO counterparts to work with clinical sites to ensure high quality data collected/cleaned and good documentation at site level
⚫Conducts accompany site visit per ASV plan, identify issues and ensure site level CAPA development.
⚫Lead clinical site audit response and action plan development, and ensure site level CAPA implemented
⚫Reviews Monitoring Visit Reports and provide feedback to CRO study manager or inhouse CRA manager as needed
⚫Support study/country TMF setup and maintenance, oversight site level TMF management following the SOP and study specifications and ensure good documentation and inspection readiness through the study conduct
⚫Support CRA or CRO counterparts for site level issues/risks identification and resolution.
General:
⚫Share with team any best practices and lesson learnt.
⚫Good cross function collaboration to promote project development
⚫Support external stakeholders visits to help build up or maintain good working relationship