Clinical Data Manager - Early Phase
临床数据管理者 - 早阶段 全程远程或混合型 在早期研究中，你有过领先的数据管理活动经验吗？你正在寻找一个环境中新的挑战，在该环境中将得到你的经理，同行和团队中的高级领导者的密切支持？也许你正在寻求获得新治疗领域的进一步经验。加入我们的日益增长的团队并通过在我们早阶段团队内担任临床数据经理发现你的非凡潜力。你可以从我们那里期待什么 · 有办公室或家居所在地在列表的国家任何地方 · 在一家既定，多样化的，高利性和受尊敬的全球公司工作具有回报和意义 · 具有高度竞争力的补偿方案，包括各种地方福利如养老金缴纳，免费医疗保险计划，远程工作津贴等。· 一个真正的职业生活平衡 · 在工作时间中的灵活性。• 通过个人导师的支持进行全面调整。· 与 Fortrea 药品开发公司签订永久性就业合同和有价值的职业生涯进展。· 负责根据确定的时间表分配的所有 DM 成果；向他们的 DM 研究团队提供指导，并审查其研究团队的产品以确保最高质量，同时相应地调整资源配置。· 开发和维护客户关系，并审查客户满意度调查。·跟踪范围变化，与项目经理合作，以确保赞助商获得批准，以及处理范围变化。· 在 DM 相关临床试验过程中提供领导，辅导和教练。· 负责学习新的医疗保健技术和应用过程，保持行业范围内的技术的最新情况以及改善工艺的可行性。你的个人资料 · 大学/大学学位 （生命科学，药学或相关专科优先）,或者从适当认证机构获得有关卫生职业的认证 （例如护理认证，医学或实验室技术）. · 其他相关工作经验将被考虑取代正式资格。
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Clinical Data Manager - Early Phase – full remote or hybrid
Do you have experience leading data management activities across early phase studies? Are you looking for a new challenge in an environment where youwill be closely supported by your Manager, peers and Senior Leaders in your team? Perhaps you are seeking to gain further experience in new therapeutic areas.
Join our growing team and discover your extraordinary potential by working as a Clinical Data Manager within our Early Phase team.
What you can expect from us
- Office based or home based anywhere in the listed countries
- Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
- Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
- A genuine work life balance
- Flexibility in working hours
- A thorough onboarding with support from your personal mentor
- A permanent employment contract with Fortrea Drug Development and a rewarding career progression
Your responsibilities
- Lead studies including (but not limited to) a combination of healthy volunteer and patient
- populations, multi-site, client management required or reduced timelines. Ability to
- organize and effectively prioritize workload and deliverables.
- Be accountable for all DM deliverables as assigned per the established timeline; providing
- instruction to their DM study team(s) and review of their study team’s output to ensure the
- highest quality, while adjusting resource allocations accordingly.
- Develop and maintain client relationships and review client satisfaction surveys.
- Track scope changes and work with the Project Manager to ensure that Sponsor approval is
- received, and the scope change processed.
- Provides leadership, mentorship, and coaching in DM related clinical trial processes to the
- internal study team.
- Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Fortrea.
Your profile
- University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
- Additional relevant work experience will be considered in lieu of formal qualifications.
- Experience in clinical data management as a Lead DM or Senior CDA or similar within early phase trials at CRO/pharma level.
- Excellent oral and written communication and presentation skills.
- In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
Learn more about our EEO & Accommodations request here.
Originally posted on Himalayas