職位描述
職位描述：
Therapeutic Area responsibilities:
1/ Strategic Responsibilities
– Serve as the GCO Lead in related China Compound Teams to provide functional input and expertise to the development of China compound strategy to achieve optimal efficiency and effectiveness in clinical program development & execution
– Serve as the liaison of local TA (Clinical Development), and some other functions of China R&D
– Serve as the primary contact for RTAE and possibly for CPL, for trial planning and management and other related development activities in China
– Build strategic relationships with network of investigators
– Find and develop new investigational sites
– Support local training on disease areas and protocol, as appropriate
2/ Operational Responsibilities
– Strong interaction with China R&D China Compound Team (CCT) members, Commercial and departments within GCDO and outside of GCDO, i.e., GCDO- GPL and GTL), GCDO-MAO, Regional Therapeutic Area Expert (RTAE), Integrated Data Analytics and Reporting (IDAR), Clinical Supplies Unit (CSU), Quality and Compliance (QC), and external partners such as KOLs, Academic Centers, Investigator Networks, external vendor groups etc.
– Early input in protocol design for China (do-ability)
– Propose China specific recruitment plan for both global trials as well as China along trials (feasibility)
– Follow up on trial performance versus China plan and trigger mitigation actions in collaboration with GTL/CTM or/and RTAE and LTMs
– Responsible for project planning and support for study execution and monitoring
– Support Site inspection and Audit readiness if needed
– Ensures all operational objectives are met in conformance to all relevant ICH-GCP regulations, guidelines including Health Care Compliance, and internal SOPs, Work Instructions, and Policies
– Support Clinical Trial Head in related Therapeutic Area(s) in managing and developing LTMs, and may support the LTMs in managing new trials in China, if needed
– Collaborates with the RTAE on country capabilities and study placement for assigned Therapeutic Area(s) or study portfolio.
– Accountable for study feasibility in country for assigned Therapeutic area or study portfolio.
Functional Management responsibilities:
– Take the role of line management of a team of SMs (Site Managers)
– Evaluates and projects resource needs for assigned portfolio, and liaises with local GCO management for resource requests as appropriate.
– Interviews, hires, develops and trains staff
– For employees: Responsible for performance and development in accordance with the Performance Management
guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment
– Ensures staffs have a clear understanding and knowledge of GCO SOPs, Work Instructions and Company Policies supported by documentation of training compliance in Learning @ Pharma R&D, Summit or applicable training documentation systems.
– Supports staff in communications with Ethics Committees, Health Authorities, Investigational Sites and groups external to GCO
– Coaches staff in their role in local Health Authority site inspections and follow-up activities including CAPA generation
– Appropriate and timely issue escalation to line management and study team as appropriate. Report (suspicion) of fraud or scientific/ethical misconduct.
– Communicates with staff on program changes, policy changes and priority shifts
– Conducts Accompanied Site Visits with Site Managers
– Review and approve expenses; assure expenses are in compliance with the company’s policies.
– Demonstrate Leadership Behaviours in alignment with Leadership Imperatives
– Fosters an environment that encourages the sharing of ideas, information, and best practices (internal and external to the organization)
– Participates in special initiatives as needed and guides rollout of new processes and procedures
– Supports metrics review and necessary follow-up actions
Qualifications
Minimum Bachelor's degree in Clinical Medicine or Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy), higher degree is preferred.
Minimum of 6 years’ experience in clinical research and strong therapeutic experiences in China. Understanding of all logistical aspects when conducting local, or regional/global clinical trials. Solid knowledge of GCP and relevant local regulations related to clinical research. Capable of providing TA, compound and protocol training in China as necessary. Strong knowledge on drug development, clinical research operations and regulatory requirements including GXP, ICH and local regulations or FDA CFRs (if applicable). Strong ability to synthesize and evaluate data generated from various reports and sources.
Excellent interpersonal skills and ability to demonstrate leadership. Internal and external partnering; ability to build relationships across the business internally and externally; ability to influence clinical research strategies to ensure successful execution of current and future clinical trials. Ability to identify opportunities for improvement and drive innovation in GCO organization. Experiences with people management role. Effective communication and leadership skills and ability to foster team productivity and cohesiveness. Experience mentoring/coaching others. Experience with people management is desirable. Ability to lead hiring, training, development and evaluation of people.
Proficiency in writing and speaking of English; Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.
