上海招聘

General Description:

Lead PMA or CTA team, to provide effective technical and administrative support for Clinical Operation China related activities in compliance with the standards, procedures and regulatory guidelines as well as business needs.

Provide efficient management on PMA or CTA team, to ensure team resource, capacities and skills, quality and deliverables meet business needs and clinical trial metrics.

Provide expert knowledge on the execution of clinical trials, expert understanding of ICH/GCP Guidelines and other applicable regulatory requirements.? Manages and develops CTA or PMA. Assures hiring, training, development in line with talent and job expectations. Through effective management and development of direct reports, the team leader 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 team resource and ensure best resource management practice. Interview potential CTA candidates, train and mentor new staff / junior colleagues.

Supervise Clinical Trial Assistant 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.

Manage CTA/PMA “central role” including but not limited to clinical trial supply management, budget and expenses management support, project meeting management, trial posting support, vendor selection and management, paper TMF and eTMF management, various clinical trial tracking report running and management. Supervise and maintain operational tracking and reporting systems and tools.

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.

Lead PMA team for technical support to all studies managed by CO China, with close cooperation with study team. Support COM, SSU lead on project management on project level to meet project goals, with best practice of technical and administrative support.

Manage site level activities support to SSU and 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.

Manage CTA/PMA to provide and optimize office staff onboard and off board process support, office activity and event coordination support. Office environment management and other required admin jobs.

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, CST functions and so on

Provide support and/or CTA/PMA staff 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.

Provide expertise in nonproject activities. Continuously and proactively identifies and proposes solutions for process improvement for the business.

Supervisory Responsibilities:

Line Management of direct reportsCompetencies:

职位要求：

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.Computer Skills: Good knowledge of all Microsoft Office programs

Other Qualifications:

Bachelor or higher degrees

Read, write, and speak fluent English

Experience supervising or managing CTA in a clinical research environment required

Good communication skills

Creative and innovative mindset, proactive working attitude

Travel: Less travel

百济神州是一家植根中国的全球性商业化生物医药公司，致力于成为分子靶向药物和免疫肿瘤药物研发，及商业创新领域的全球领导者。
2017年，百济神州与新基公司达成战略合作伙伴关系，向新基转让了tislelizumab在美国、欧洲、日本和亚洲以外的其他地区的实体瘤开发和商业化的独家权益，保留了在亚洲（除日本外）开发和商业化tislelizumab用于治疗实体瘤的权益，以及用于治疗恶性血液肿瘤和进行内部组合疗法的全球范围权益。

此外，百济神州获得了新基公司在华获批药物——注射用白蛋白紫杉醇（ABRAXANE？）, 瑞复美（REVLIMID？）和 维达莎（VIDAZA？）的独家授权，并接管其在华商业运营团队。

2018年1月，百济与Mirati公司sitravatinib在亚太地区的独家授权协议，进一步拓宽了公司的产品组合。

截至目前，百济神州在全球各地拥有超过1100名员工，其中包括在中国、美国、澳大利亚和瑞士的超过650名科学家及临床医学专家。

公司在中国的北京、上海、美国的马萨诸塞州Cambridge，新泽西州Fort Lee和加利福尼亚州旧金山Emeryville和San Mateo，瑞士的巴塞尔均设有办事机构。除此之外，百济神州在中国大陆还拥有位于北京的研发中心，苏州、广州两大生产基地，以及在上海的商业运营中心。