高级临床数据经理（远程 - 哥伦比亚）
Senior Clinical Data Manager (Remote - Colombia)
你是否希望加入一家你的贡献真正重要的公司，并成为一支有支持力、富有创新精神的团队的一员？MMS 是一家获奖的以数据为导向的临床研究组织（CRO）。我们自豪于是一家获得 Great Place to Work 认证的公司，因卓越的企业文化和行业领先的员工保留率而受到认可。我们以经过验证的科学方法，为制药、生物技术和医疗设备行业提供复杂试验数据和监管提交挑战的支持。MMS 在四大洲拥有全球业务，不仅保持了行业领先的客户满意度评级，还营造了一个协作且包容的工作环境，让员工能够茁壮成长。加入 MMS，成为塑造临床研究未来的一份子。
了解更多关于我们激动人心的机会以及为什么 MMS 是提升你职业生涯的理想之地。访问或关注 MMS 的 LinkedIn 页面。
请提交英文简历！
我们正在寻找一名全职员工，远程办公地点在哥伦比亚任何地区。
职位职责：
- 能自信地展示出色的内部和外部客户服务能力。
- 精通多种 EDC 系统；能够运用这些知识为客户推荐最适合的 EDC 解决方案。
- 能够直接独立地与 DM 供应商（包括 EDC 和/或 IWR）进行沟通；具备优秀的沟通能力，必要时可与供应商协商以满足业务需求。
- 能够直接独立地与客户沟通，协调项目的各个方面；具备优秀的沟通能力；建立并维护良好的客户关系。
- 负责从研究启动到研究结束的整个数据管理流程；是所有数据管理相关问题的主要联系人；对药物开发中与数据管理相关的知识有深入了解。
- 积极参与与客户的方案审查，就如何成功在数据库中捕获方案信息提出建议。
- 对 GCP/ICH 指南和 FDA 法规有深入理解，适用于数据管理方面。
- 制定培训练习；担任导师并培训新的临床数据管理人员。
- 对数据管理研究处理活动中的所有问题进行监督并解决，包括 CRF 跟踪和数据录入、外部电子数据（如实验室数据）与临床数据库的整合、数据验证和审核、查询处理等。
查看英文原文
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn.
Kindly submit your CV in English!
We are looking for a full-time employee, remotely based within any location in Colombia.
Roles and Responsibilities:
- Confidently displays excellent internal and external customer service.
- Has proficiency and knowledge of multiple EDC systems; applies this knowledge to advise customers regarding the best-fit EDC solution.
- Interacts directly and independently with DM suppliers including EDC and/ or IWR; expert communicator, where necessary negotiating with supplier to meet business needs.
- Interacts directly and independently with client to coordinate all facets of projects; expert communicator; builds and maintains strong client contacts and relationships.
- Responsible for entire data management process from study set-up to study close-out; primary contact on all data management study-specific issues; has high-level knowledge of drug development as it pertains to data management.
- Actively participates in protocol review with clients, providing suggestions regarding ability to capture protocol information in database successfully.
- Strong understanding of GCP/ ICH guidelines and FDA regulations, as applicable to data management.
- Creates training exercises; serves as mentor and trains new clinical data managers.
- Provides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits.
- Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan.
- Preparation of any study tracking and metric reports for use by the study team.
- Oversees execution of user acceptance testing (UAT) of study-specific systems and applications.
- Interacts with cross-functional team members to ensure completion of all timelines and studies.
- Participates in data management and/or organizational initiatives.
- Initiates SOP updates and provide specifications for DM systems/ tools and process enhancements.
- May act as resource for QC activities in collaboration with QC Coordinator.
- Understands and follows processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures, etc.).
- Confident, positive attitude displayed towards clients and projects.
- Willingness to learn new skills and expand knowledge of drug development.
- Leads data management projects with little management oversight.
- Ability to work independently and resolve issues.
- Ability to clearly articulate the DM services offered at company, including pros and cons of various DM approaches (specific to a client or operating model). To include potential attendance at (web or remote) capabilities and bid defense meetings.
Requirements:
· Bachelor’s or Master’s Degree in scientific or health care field preferred with industry or relevant experience.
- 5+ years’ experience in data management field with a minimum of 1 year of experience leading projects.
- Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.
- Extensive knowledge of Clinical Operations SOPs and Working Practices.
- Excellent verbal and written communication skills, as well as, interpersonal and organizational skills.
Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.Originally posted on Himalayas