GCO Director, Clinical Trial Head Job

Job description

GCO Director, Clinical Trial Head-1500016028WDescriptionClinical Trial Operation1. Oversee project teams in conducting global and local clinical trials. Oversee clinical trials in terms of planning, compliance with company policies and procedures, compliance with regulatory standards, data quality, risk management, issue management and escalation, scientific excellence and meeting key deliverables.2. Ensure the conduct of protocol do
- ability and feasibility in sufficient/potential sites at country/site level, and provide appropriate feedback for assigned clinical programs in the specific therapeutic area.3. Work closely with compliance team to assure trial quality and inspection readiness4. Review protocol and other study documents and provide high quality input as required.5. Continuously improve TCSM productivity and assure quality standard at project level.
Clinical Research Support for R&D and Scientific Affairs (SAF)6. Take the lead to develop strategic long-term collaboration with top and/or new sites to optimize recruitment of patients into our clinical programs, and offers additional support to new sites in to build up the right clinical research infrastructure.7. Develop clear lines of communication and collaboration with relevant stakeholders, including RA, CD and RTAE to accelerate product registration and launch readiness through clinical trials and to support post registration activities through data generation activities.8. High quality input to clinical study strategies for the development of new products from assigned therapy areas as required9. High quality Input to protocol synopsis and protocol to make sure the studies are able to be conducted in China sites as required10. Establish an effective network of relationships internally between JNJ cross functions and externally outside of company, with key opinion leaders and sites. Acquire deep insight on the real operation environment of TA.People Management11. Responsible for the recruitment and development of project leader and team leader role (GCO Manager/LTM) in the team12. Responsible for GCO manager and LTM development including goal setting, performance evaluation and management, development to maximize potential of direct reports. Ensure team are motivated and engaged. Model and inspire Credo values.13. Provide input to Head of Business Operations in resource management systems as current and accurate e.g.1-supply and P5. Ensure enough resource could be allocated to appropriate projects.14. Facilitate lessons learned and sharing of best practice at a local and regional levelOther assignment15. Seamless collaboration with internal cross functional teams for problem solving, overcoming obstacles to ensure project timelines are met.16. Maintain adequate communication with KOLs and relevant parties within and outside the company.17. Report (suspicion of) fraud or scientific/ethical misconduct as appropriate.18. Contribute to department, region or global projects as assigned to continuously improve our efficiency and quality.19. Perform CPL(clinical program leader) role for single China studies.
Qualifications
- Tertiary qualification; life science, medical, paramedical, pharmaceutical related degree
- Minimum 8 years appropriate industry experience
- Excellent working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Experience leading people
- Deep knowledge with the TA
- Team oriented personality with high degree of flexibility
- High degree of trust-confidence between Team managers and line manager
- Excellent written and oral communication skills. Strong IT skills in appropriate software and company systemPrimary Location:Asia Pacific-China-Beijing-BeijingOrganization: Xian-Janssen Pharmaceutical Ltd. (7043)Job Function: R&D