南京招聘

General Summary

The Associate Director of Clinical Operations is responsible for recruitment, growth, and development of Clinical Operations employees. They provide leadership in the implementation of Company’s quality initiatives and business processes, achievement of its management goals and objectives within the framework of the company mission, policy and philosophy.

Key responsibilities

1.      Manage and develop Company employees to ensure high quality work performance and retention of high quality employees:

?         Develops plans to support growth and career development of assigned Clinical Operations employees as well as manage the delivery of quality performance in line with their job description.

?         Ensures staff development and performance feedback are provided through activities such as mentorship and career development

?         Communicates team and individual goals and expectations to ensure direct reports understand their responsibilities

?         Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.

?         Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed customer expectations.

?         Conducts assessment visits with staff as required by SOPs

2.      Responsible for the management of resources and resource projections to ensure project   teams are consistent with client needs, expectations and contractual expectations by:

?         Reviewing project tasks and timelines and assigning team members

?         Determines level and type of employee resources to meet corporate/client/project objectives

?         Schedules and reviews project tasks, provides leadership in the delivery of services to clients

?         Provides guidance/insight on aspects of clinical operations, as well as contingency                                                                              planning, to accommodate project or therapeutic-specific nuances while identifying potential impacts to the budget

?         Leading Clinical Operations employees in the delivery of services to clients

?         Ensuring staff fulfill their responsibilities in accordance with Company’s policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements

?         Liaising with other functional managers to ensure consistency within the company

?         Maintaining utilization of all Clinical Operations employees within department goals

3.        Provides leadership and implement Clinical Operations services and productivity improvements to ensure optimal utilization of billable staff by:

?         Performing metric collection and data analysis to support Company’s continuous improvement in policies, procedures, and business process

?         Identifying and implementing process improvements through review of clinical operations SOPs, processes; recommending improvement plans to senior management.

?         Leading task forces to implement process improvement initiatives

?         Building teamwork and improving process and productivity by working within and across functional areas

4.       Be a point of escalation (internal) for resolution of issues and conflicts.

5.       Evaluates compliance of assigned Clinical Operations employees with Company systems and processes.

6.       Provides support with proposal development and participates in client presentations and/or bid defense meetings, as required

7.       Mentors and trains other Clinical Operations management level employees

● Designs and delivers relevant training to the Clinical Operations teams and/or management groups.

● Viewed as a mentor and a go-to resource across all services within the Clinical Operations group and as a subject matter expert by staff outside of Clinical Operations.

       8.    Displays expertise in the position by:

                ● Leading process development/ improvement task force

                ● Developing tool(s) to improve Clinical Operations processes

                ● Acting as a Subject Matter Expert (SME) for various initiatives.

                ● Leadership on programs and/or initiatives that are increasingly complex in their scope of services,   technology employed, volume, and/or revenue.

9.       Assists more senior Clinical Operations staff in the review, development and implementation of  short-term and long- term objectives, major plans and programs for each functional group within Clinical Operations.

10.   Creates and maintains effective relationships between other business units or functions.

11.   Participates in internal/external audits and regulatory agency inspections, as required.

Job Factors (Knowledge, Skills and Abilities)        Knowledge & Skills

          Advanced understanding and application of Clinical Operation processes, SOPs and work instructions.

          Proven history of successful interaction with leaders within Clinical Operations and also other project team operational groups.

          Can identify potential future managers and delegate specific tasks to them to begin to develop their management skills.

            Applies Clinical Operations knowledge to review current processes and to drive continuous improvement in global processes

        Problem solving Fact Finding & Analysis

          Resolves complex and diverse problems with decision making responsibility that has a significant impact (e.g., stakeholder relationships, compliance status, credibility and/or revenue) within Clinical Operations and across the company.

         Stays ahead of ever- changing industry requirements while ensuring product quality.

           Ability to solicit input and liaise with stakeholders to prioritize and set strategic directions for change.

       Impact

          Inability to identify potential managers will cause issues with succession planning.

           Erroneous decisions or failure to achieve results will negatively impact the quality of delivery, client relationships, and operational health.

       Supervision Given/Received

         Limited supervision under the guidance of Management. No instruction needed on routine work and only general instructions with periodic review given new work or special assignments.

      Provides guidance and mentorship to team members of various levels within Clinical Operations in resolving issues and overcoming study and/or staff challenges.

       Serves as a knowledge source to team members outside of Clinical Operations.

 

Qualifications

          Education

  ?   Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution required

         Experience

      Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets required

    Substantial clinical trials development experience is required

    Appropriate direct line management experience Of Clinical operations staff

      Thorough knowledge of ICH and local regulatory authority regulations regarding drug

Research and development is required.

      Read, write, and speak fluent English; fluent in host country language required.

      Preferred Education and/or Experience 

?    Advanced degree, or its international equivalent, preferred

  

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。