高级经理，临床数据管理
Senior Manager, Clinical Data Management
职位描述：
该高级临床数据管理经理将作为一项或多项临床研究或项目的首席数据管理人员，从研究启动到数据库锁定，对研究层面的数据管理活动提供战略和操作层面的监督。这是一个需要经验丰富的临床数据管理专业人士亲自参与的角色，能够独立推动执行工作，与跨职能团队和CRO有效合作，并在快节奏的环境中保持高质量的数据。
成功候选人将负责研究执行、供应商监督、数据库构建测试活动、风险识别、数据审查和数据质量管理。该职位需要良好的判断力、强大的沟通能力、责任感，以及在处理竞争性优先事项、变化的需求和时间敏感的交付物时仍能保持高效的能力。
您将如何做出贡献：
- 作为指定临床研究和项目的首席数据管理人员，制定并维护针对研究的数据管理策略、时间表和交付成果。
- 审核并批准关键的数据管理文件，包括数据管理计划、数据验证计划、编辑检查规范、eCRF规范和数据库构建文档。
- 提供对Medidata Rave EDC数据库构建的实际监督，包括eCRF、编辑检查、自定义功能、工作流和相关配置；创建、运行、审核并解读Rave报告和列表，以支持数据审查、清理、对账和监督。
- 规划、执行并记录数据库构建、编辑检查、eCRF、派生项和系统功能的测试；识别缺陷，评估影响，跟踪解决过程，并通过UAT验证修复。
- 领导数据审查、问题管理、外部数据对账和数据库锁定活动，包括对CRO和供应商交付成果的监督。
- 监控数据质量，审查指标和研究时间表以尽早识别风险，并支持外部数据集成、传输规范、对账活动和检查准备。
- 在研究进行过程中与临床运营、生物统计学、统计编程、医学监测、药物警戒和外部供应商合作；及时提供数据管理活动、风险、决策和时间表的清晰更新，并在适当情况下上报问题。
- 审核CRO财务报告、变更通知和相关数据管理内容
查看英文原文
The Role:
The Senior Manager, Clinical Data Management will serve as the lead data manager for one or more clinical studies or programs, providing strategic and operational oversight of study-level data management activities from study start-up through database lock. This is a hands-on role for an experienced clinical data management professional who can independently drive execution, partner effectively with cross-functional teams and CROs, and maintain high data quality in a fast-paced environment.
The successful candidate will be responsible for study execution, vendor oversight, database build testing activities, risk identification, data review, and data quality management. The role requires sound judgment, strong communication, accountability, and the ability to remain effective while managing competing priorities, changing requirements, and time-sensitive deliverables.
Here's how you will contribute:
- Serve as the lead data manager for assigned clinical studies and programs, developing and maintaining study-specific data management strategies, timelines, and deliverables.
- Review and approve key data management documents, including Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation.
- Provide hands-on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, and related configuration; create, run, review, and interpret Rave reports and listings to support data review, cleaning, reconciliation, and oversight.
- Plan, perform, and document testing of database builds, edit checks, eCRFs, derivations, and system functionality; identify defects, assess impact, track resolution, and verify fixes through UAT.
- Lead data review, query management, external data reconciliation, and database lock activities, including oversight of CRO and vendor deliverables.
- Monitor data quality, review metrics and study timelines to identify risks early, and support external data integrations, transfer specifications, reconciliation activities, and inspection readiness.
- Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and external vendors throughout study conduct; provide clear, timely updates on data management activities, risks, decisions, and timelines, and escalate issues as appropriate.
- Review CRO financial reports, change notifications, and associated data management expenses to support appropriate scope, budget, and timeline oversight.
- Build constructive working relationships and navigate challenging situations with professionalism, respect, and a solutions-oriented approach.
- Contribute to the continuous improvement of data management processes, standards, tools, and templates; share best practices and align day-to-day decisions with company goals, study priorities, patient safety, and program success.
The Ideal Candidate will have:
- Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related discipline; an advanced degree is preferred.
- At least 7 + years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
- Required hands-on experience with Medidata Rave EDC, eCOA and RTSM.
- Demonstrated experience creating, running, reviewing, and interpreting Medidata Rave reports and listings.
- Demonstrated experience testing clinical database builds, UAT scripts, edit checks, eCRFs, and database changes, including defect documentation and retesting.
- Solid understanding of database design, edit checks, data review, query management, external data reconciliation, and database lock processes.
- Strong knowledge of ICH-GCP and applicable regulatory requirements.
- Experience reviewing CRO study finance reports, change notifications, and data management expenses.
- Excellent written, verbal, and interpersonal communication skills, with the ability to communicate clearly with both technical and non-technical stakeholders.
- Strong organizational and prioritization skills, with the ability to multitask, manage competing deadlines, and maintain attention to detail.
Preferred
- Experience with Spotfire or similar data visualization and analytics tools.
- Experience working in a small to mid-sized biotechnology company environment.
- Familiarity with CDISC standards, risk-based data review methodologies, and external vendor data integrations.
Key Competencies
- Demonstrated ownership, accountability, and follow-through for study deliverables.
- Ability to work effectively in a high-pressure, fast-paced environment while maintaining quality and sound judgment.
- Ability to manage ambiguity, adapt to changing priorities, and make timely, risk-based decisions.
- Excellent communication, active listening, and stakeholder management skills.
- Collaborative and respectful team member who can build trust across functions and maintain productive relationships during challenging situations.
- Proactive problem-solving and risk-management mindset.
- Ability to influence without direct authority and drive accountability across internal teams and external partners.
- Commitment to company goals, patient-focused execution, data quality, compliance, and operational excellence.
About Generate Biomedicines
We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.
Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.
At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.
Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
Per Year Salary Range
$140,000—$196,000 USD
Originally posted on Himalayas