临床运营经理 FLEX
Manager Clinical Operations FLEX
职责
根据组织的政策和适用法规管理员工，包括但不限于：计划、分配和指导工作；管理绩效并指导职业发展；奖励和纪律处分员工；处理员工关系问题并解决问题；在下属发展其角色时担任教练和导师。
参与新员工的选拔和入职流程，包括审查候选人并参与面试过程。与人力资源和学习与发展培训项目合作，为新员工提供入职培训。
- 确保员工拥有完成工作职责所需的材料、系统访问权限和培训。监督培训计划、SOP审核和指导培训的执行情况。
- 参与资源分配，将员工分配到与其经验和培训相适应的临床研究中。
- 管理并审查下属的工作量和工作质量。
- 识别质量风险和问题，并支持制定适当的纠正措施计划，以防止或纠正员工绩效中的不足。
- 可能作为CRA或其他角色参与特定项目或协助达成里程碑。
- 可能参与临床运营质量或流程改进项目。
经验与资格
生命科学或相关领域的学士学位（BS）。研究生学位优先。
- 10年临床研究环境中的临床研究助理经验，3年CRA管理经验优先。
熟悉整个临床试验中的所有临床运营活动。
具备良好的ICH-GCP知识、适用法律（本地和国家）及监管要求。
- 出色的组织能力、文件保留能力和时间管理技能。
- 领导力强：冲突解决能力、情商、结果导向、分析问题和解决问题的能力、激励和鼓舞他人的能力、出色的沟通能力。
- 良好的英语口语和书面表达能力或其他第二语言技能。
Novotech自豪地提供一个优秀的工作场所。我们致力于成为性别平等的首选雇主，并提供一个包容的工作环境，其中每个人都能得到公平和尊重的对待。
我们的团队成员
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Responsibilities
Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role.
Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
- Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
- Participate in the allocation of resources by assigning staff to clinical studies that are appropriate to their experience and training.
- Manage and review the workload and quality of subordinates' work performance.
- Identifies quality risks and issues and supports the creation of appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
- May act as a CRA or other role for a defined project or to assist with milestone achievement.
- May participate in clinical operations quality or process initiatives.
Experience and Qualifications
A BS (Bachelor of Science) degree in Life Sciences or a related field. Advanced degree is a plus.
- 10 year experiences as a clinical research associate in clinical research environment is preferred， 3 year experience in CRA management.
Familiar with all clinical operation activities throughout an entire clinical trial.
Excellent working knowledge of ICH-GCP, applicable law (local and country) and regulatory requirements.
- Excellent organizational, record retention and time management skills.
- Leadership strength: Conflict resolution, Emotional intelligence, Drives for results, Ability to analyze issues and problem solving, Ability to inspire and motivate others, Excellent communication skills.
- Good verbal and written English or other second language skills.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
Originally posted on Himalayas