锦鲤求职岗位描述
Position Summary
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
Key Responsibilities
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
Recommended Education and Key Competency
Basic Qualifications
Minimum bachelor’s degree with major in medical, biology, pharmacology or other life sciences subject
Minimum 4 years of site management experience
Minimum 2 years study management working experience
Preferred Qualifications
Study management at trial level
Trial management experience for multi-country studies
Previous audit and inspection management experience
Knowledge
Extensive knowledge of ICH/GCP regulations and guidelines.
Advanced knowledge of China clinical trial management including regulations and guidelines
Clinical trial processes and operations expertise
Project and program management.
Time, cost and quality metrics
Multiple Therapeutic Area knowledge
Key Competencies
Project and Operational Excellence
Interpersonal Savvy
Organizational Savvy
Stakeholder Engagement
Managing Change (Learning agility)
Analytical Thinking and Innovation
Strategic Risk Management
Resource Management
Joint Value (Courage & Speak up)
Scientific
Quality
Language:
Chinese & Business English fluency