南京招聘

General Summary

The Manager 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 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

1. 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

1.  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

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

2. Evaluates compliance of assigned Clinical Operations employees with COMPANY systems and processes.

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

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

        Excellent written and oral communication.

        Has a good knowledge of Clinical Operations processes and systems.

        Understands interrelation of Clinical Operations functions within the department and across the full clinical trial process.

        Ability to set expectations and monitor employee performance.

        Strong mentoring and leadership skills

        Ability to identify and hire strong candidates through hiring processes

          Comprehensive knowledge of COMPANYs SOPs, WIs, and other policies and processes required by functional managers.

        Problem solving Fact Finding & Analysis

         Drives plans to resolve Clinical Operations issues escalated from team members. Uses data to present ideas, concerns and solutions.

        Proactively obtain information and/or assistance from peers, mentors, subject matter experts and Functional Director team to resolve more complex and difficult issues.

          Identifies actions that need to be taken and proceeds to resolution.

          Uses existing processes, SOPs, related work instructions and study specific guidance and documentation to mentor Clinical Operations employees’ tasks and responsibilities.

       Impact

         Erroneous decision will result in critical delay(s) in schedules and/or Clinical Operations and may jeopardize overall Clinical Operations activities.

         Erroneous decisions will jeopardize company quality performance and client relations.

           Errors in leadership and mentoring may cause increased turnover.

           Lack of good leadership will result in failure to meet staff and dept goals.

       Supervision Given/Received

        Identifies issues with little to no upper management direction.

        Develops solutions independently.

        May require occasional assistance on day to day management tasks including resourcing, hiring, and staff management.

          Will require assistance handling serious issues in project and team performance.  

 

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

• Experience supervising or managing professional staff in a clinical research environment required

• 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。