Head of Data Standards & CRF Design (all genders)
发布于 1 天前中层管理(经理/总监)
值不值得投
综合评分 84
Global Director role in a top-tier pharma company, offering strong career growth, cutting-edge tech exposure, and high social impact with a hybrid work model.
从薪资福利、成长发展、工作生活和使命价值四个维度综合评估，方便横向比较。
薪资怎么样
7.5万
比数据治理中位数高
发布情况
新岗位 · 昨天发布
公司情况
这家公司招聘很活跃
60 个在招
市场机会
选择面较广
数据治理 · 67 个在招
职位详情
关于这个职位
该职位负责领导全球团队，制定和实施临床数据标准（如CDISC）及CRF设计，确保数据交付物符合监管提交要求
最低要求
拥有生命科学、数据科学、信息系统、计算机科学或同等科学/技术学科的高级学位
工作职责
领导全球团队，负责临床数据标准、CRF设计、元数据治理和提交就绪的数据交付物
优先资格
具有新兴标准和技术经验，如Dataset-JSON、SDTM v3.0、CDISC Open Rules、ICH M11、HL7 FHIR-to-CDISC互操作性，或AI支持的元数据和方案到CRF自动化
AI 洞察
优缺点分析
优点
- High-impact global leadership role in a top-tier multinational pharmaceutical company.
- Exposure to cutting-edge technologies like AI-enabled metadata and HL7 FHIR.
- Strong platform for influencing industry standards and driving digital innovation.
- High complexity in managing global teams and cross-functional stakeholders across different time zones.
- Navigating stringent regulatory requirements and ensuring inspection readiness in a highly scrutinized environment.
- Experienced clinical data professionals with strong leadership skills, seeking a strategic global role to drive data standards and regulatory innovation in the pharmaceutical industry.
缺点 / 挑战
暂无明显挑战项
角色解读
- Progression into higher executive roles within clinical operations or data management.
- Opportunity to shape industry standards and drive digital transformation in clinical trials.
- Lead a global team to define and implement clinical data standards (e.g., CDISC) and CRF design.
- Ensure metadata governance and regulatory submission readiness for SDTM packages in outsourced studies.
- Collaborate with cross-functional teams and external partners to drive digital innovation in clinical development.
- Deep expertise in CDISC standards (SDTM, CDASH, Define.xml) and eDC study build.
- Proven track record in leading global, multidisciplinary teams and managing vendor/CRO partnerships.
- Strong executive communication and stakeholder influence skills.
申请策略
- Demonstrate your understanding of Merck's mission and commitment to innovation in healthcare.
- Be prepared to discuss specific examples of how you've driven digital transformation or improved submission readiness in past roles.
- Highlight your 10+ years of progressive experience in clinical data standards and specific leadership roles managing global teams.
- Showcase successful regulatory submissions (SDTM, Define.xml) and experience with CDISC standards.
- Emphasize cross-functional collaboration and vendor/CRO management achievements.
- Familiarize yourself with emerging standards like Dataset-JSON, ICH M11, and AI-enabled metadata automation.
- Enhance your executive communication and change leadership capabilities.
面试指南
- Use the STAR method (Situation, Task, Action, Result) to structure your answers.
- Focus on quantifiable outcomes, such as improved submission success rates or reduced cycle times.
- Highlight your collaborative approach with cross-functional teams and external vendors.
- Can you describe your experience in leading global teams for clinical data standards implementation?
- How do you ensure inspection readiness and high-quality SDTM submissions in outsourced studies?
- What is your approach to metadata governance and version control in a global repository?
- How have you leveraged emerging technologies like AI or HL7 FHIR in your previous roles?
- Review the latest CDISC guidelines and emerging standards like ICH M11.
职位点评
薪资福利
As a Director-level role in a multinational pharmaceutical company in Greece, it offers a highly competitive salary and comprehensive benefits, reflecting the senior leadership responsibilities.
成长发展
The role provides significant opportunities for career growth, leading global teams, and shaping industry standards, with exposure to cutting-edge technologies.
工作生活
The hybrid work model (3 days on-site) offers a good balance, though the senior leadership role may require flexibility and occasional high workload.
使命价值
The role directly contributes to bringing life-changing healthcare solutions to patients, aligning with a strong sense of mission and social impact.
默克药厂 的其他在招职位
Principal Agentic AI Engineer
默克药厂 · Jerusalem, Jerusalem, IsraelAI 估算 · 5.5–8.5万Pharmaziepraktikum gemäß §4 Approbationsordnung für Apotheker im Bereich Qualitätssicherung (m/w/d)
默克药厂 · Darmstadt, Hessen, GermanyAI 估算 · 8千–1.2万Pharmaceutical Manufacturing Technician Overnight Weekday Shift
默克药厂 · Verona, Wisconsin, United StatesAI 估算 · 3.1–5.1万