全球研究经理 II - 西班牙 - FSP
Global Study Manager II - Spain - FSP
当我们的价值观一致时，我们能实现的没有极限。
在Parexel，我们都有相同的目标——改善全球健康。从临床试验到监管、咨询和市场准入，我们提供的每一个临床开发解决方案都源于一种特别的东西——对所做工作的深刻信念。
无论我们在Parexel做什么，每个人都在为最终能惠及患者的疗法开发做出贡献。我们认真对待工作，带着同理心去做，并致力于带来改变。
Parexel正在积极招聘一名经验丰富的全球试验经理，加入波兰/西班牙团队。
临时职位（至2027年4月）
100%远程办公。
客户专属。
在这个职位中，你将为试验团队提供领导和方向，并对根据既定里程碑和KPI完成的试验整体成功和交付负责。
你将负责指导和管理临床试验活动，包括患者和站点参与活动，与多个内部和外部利益相关者以及全球、多国或区域的团队成员进行直接沟通和互动。
该职位的具体职责
- 对试验时间表的准确规划和操作可行性负责；并监督试验准备，确保试验团队成员保持一致并按计划进行。支持其他职能（如统计、数据管理、研究医生、医学写作、站点监查）负责的试验级文档的开发。
- 验证并提供国家分配的输入，并监督试验可行性。
- 在临床试验进行期间保持监督，包括遵守GCP和所有全球及当地法规要求；遵守SOP并持续进行风险监控/缓解。与其他职能合作，确保预算监督，包括支持定期的临床质量监查、SMC/DMC管理和安全报告。
- 准备并实施核心文档的修订，包括根据需要更新培训材料或重新培训。
- 支持监管机构/伦理委员会的回应请求，如适用。
- 与其他职能合作，确保临床试验数据的及时清理和交付。协调并支持试验医学作者提供CTR。
- 负责所有相关全球文档在TMF中的及时、完整和合规归档，包括所有必要文件。
查看英文原文
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is actively recruiting for an experienced Global Study Manager to join us in Poland/Spain.
Temporary position (until April 2027)
100% remote.
Sponsor dedicated.
In this role you will provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.
You will be responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis.
Some specifics about this advertised role
- Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
- Verifies and provides input into the country allocation and oversees trial feasibility.
- Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
- Prepare and implement amendments of core documents, including training material updates/retraining as needed.
- Support authority/ethics response to requests as applicable
- In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports trial medical writer in providing the CTR.
- Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
- Support results/documents disclosure of global registries.
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
What we are looking for in this role
For every role, we look for professionals who have the determination and courage always to put patient well-being first.
That to us is working with heart.
Here are a few requirements specific to this advertised role.
- Bachelor’s degree and minimum 6 years of relevant global study management/leadership experience
- Experience with oversight of CROs and vendors
- Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
- Fluency in written and spoken English required
- Ability to work outside of core business hours, as required, to support global trials or initiatives
- Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
- Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
- Knowledge of ICH GCP and relevant regulatory guidelines/directives.
- Demonstrated interpersonal & leadership skills.
- Ability to understand and implement the strategic direction and guidance for respective clinical studies.
- Effective communication skills via verbal, written and presentation abilities.
If you are interested and meet requirements, please send your CV to
Originally posted on Himalayas