Key Responsibilities:Manages and develops CTA group. Assures hiring, training, development in line with talent and job expectations. Through effective management and development of direct reports, to ensures CTAs are in line with the principles that clinical studies are conducted within the standards according to Good Clinical Practices (GCP) and applicable regulatory and legal requirements.Manage CTA “central role” including but not limited to clinical trial supply management, budget and expenses management support, project meeting management, safety information delivery, vendor selection and management, paper TMF and eTMF management, various clinical trial tracking report running and system maintaining’s support. Supervise and maintain operational tracking and reporting systems and tools. Provide support to meeting coordination for the global / local clinical and study team members in scheduling, agenda, presentations, arrangements, minutes, and action Item tracking including investigator meetings and project related meetings. Supervise CTA team in day to day work. Establish clear direction and performance targets. Ensure clear and efficient process setting-up, on-going tracking, and data analysis to identify potential issue and improve it. Continuously supervise team on these activities and delivery outcome, to ensure process efficiencies and effectiveness, identify needs for changes and improvement, and lead required changes and optimization activities. Manage site level activities support to SSU/CRA team in each office location, including office daily admin management, paper TMF and eTMF management, site contract and payment coordination, site supply and materials providing etc. Support PM, SSU lead on project management on project level to meet project goals, with best practice of technical and administrative support. Maintain partnership with internal and external business partners to improve the working process for the function. Mainly focus on the working relationship with Finance, Procurement, HR, Sourcing, Administration, legal function and so on. Manage team resource and ensure best resource management practice. Interview potential CTA candidates, train and mentor new staff / junior colleagues. Provide expertise in non-project activities. Continuously and proactively identifies and proposes solutions for process improvement for the businessKey Activities:Recruitment, on-boarding, development and mentoring of CTA TEAM to meet biz needsManagement and oversight of CTA performance CTA resource allocation, workload assignments and the coordination of CTA activities in the clinical trial and supports and facilitates issue resolutionProvides guidance to CTA on the preparation of study start up and activities Identifies successes, risks and action plans on study issues Oversees update of Everest systems (e.g. EDC, CTMS, et al) Drives continuous process improvement with focus on quality, cost, and timeRecommended Education and Key Competency:Basic Qualifications Minimum Bachelor degree major in medical, biology, pharmacology or other life sciences subjectMinimum 8 years’ experience in the clinical operation perspective at least 3 years’ CTA experience in MMCPreferred Qualifications Experience supervising or managing CTA in a clinical research environment Global pharmaceutical company and/or global CRO working experienceKnowledge Good knowledge of all Microsoft Office programs Extensive knowledge of ICH/GCP regulations and guidelines Clinical trial processes and operations Time, cost and quality metricsKey Competencies Leadership skills including decision making, influence skills, stakeholder management Strong communication skillsCreative and innovative mindset, proactive working attitudeCan-do attitude and willingness to take challenge tasksLanguage: Chinese & Business English fluency Excellent organizational and planning skills Ability to work effectively in a changing environment
Our mission is to build a preeminent biopharmaceutical organization to develop and commercialize globally innovative products in Greater China and other emerging Asia Pacific markets.
Our advantage includes an insight-driven, highly productive business development engine and world-class clinical and regulatory teams, supported by a substantial financial foundation.
