临床试验经理 III
Clinical Trial Manager III
职位概述：
临床试验经理II负责核心项目团队内临床研究试验的临床交付和运营监督。CTM II与项目经理和其他职能负责人协作，在预算和合同范围内完成临床和启动活动，确保质量、合规性并满足国家特定的承诺。
虽然该职位可能在高级临床试验经理的指导下偶尔支持更大、更复杂的试验，但通常期望其独立且全面地管理大多数研究。
职责摘要：
- 从站点识别到数据库锁定，对启动和临床责任进行全流程监督，通过主动管理项目范围、时间表、里程碑和预算。
- 确保启动和临床项目计划应对已识别的风险，同时遵守专业标准、SOP、客户和监管要求。
- 通过应用全面的风险管理策略，主动识别和解决启动和临床项目、财务和质量风险，并确保合规性，包括在相关系统中跟踪。
- 负责临床和启动活动的财务方面，包括收入预测、遵守合同范围，并监督范围变更。
- 确保项目团队了解并跟踪任何客户特定的启动和临床指标的关键项目指标（KPI）。
- 确保并为启动和临床资源制定计划，向资源团队提供准确的预测。
- 与项目团队合作，制定站点激活和招募策略。
- 领导并监督站点识别和选择。
- 监督知情同意书的开发和翻译。
- 监督关键文件的创建和收集，包括保险。
- 监督临床试验协议（CTA）的开发、谈判和执行，包括站点预算。
- 领导监管/伦理委员会提交、批准和跟踪的全流程。
- 确保临床和辅助用品——包括进出口物流和物资销毁流程——根据需要到位。
- 管理操作方面以支持受试者招募和保留、患者安全、供应商表现和监查访问策略。
- 主动规划监查活动，以确保数据完整性、患者安全
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Job Overview:
The Clinical Trial Manager II owns the clinical delivery and operational oversight of clinical research trials within the core project team. The CTM II collaborates with project managers and other functional leads to deliver clinical and start-up activities within budget and contract, ensuring quality, compliance and meeting country-specific commitments.
While the role may occasionally support larger, more complex trials under the guidance of a Senior Clinical Trial Manager, it is generally expected to manage most studies independently and comprehensively.
Summary of Responsibilities:
- End-to-end oversight of start-up and clinical responsibilities—from site identification through to database lock—through proactive management of project scope, timelines, milestones, and budget.
- Ensure start-up and clinical project plans address identified risks while adhering to professional standards, SOPs, client, and regulatory requirements.
- Proactively identify and address start-up and clinical project, financial, and quality risks by applying comprehensive risk management strategies and ensuring compliance, including tracking within applicable systems.
- Responsible for financial aspects of clinical and start-up activities, including revenue forecasting, adherence to contracted scope, and oversight of scope modifications.
- Ensure project team awareness and tracking of Key Project Indicators (KPI) for any client-specific start-up and clinical metrics.
- Ensure and plans for start-up and clinical resources with accurate projections for the resourcing teams.
- Develop and implement the site activation and recruitment strategy in collaboration with project teams.
- Lead and oversee site identification and site selection.
- Oversight of Informed Consent Form development and translations.
- Oversight of essential document creation and collection, including insurance.
- Oversight of the development, negotiation, and execution of Clinical Trial Agreements (CTA), including site budgets.
- Lead the end-to-end process of regulatory/ethics committee submissions, approvals, and tracking.
- Ensure clinical and ancillary supplies -including import/export logistics and supply destruction processes- are in place as applicable.
- Manage operational aspects to support subject recruitment and retention, patient safety, vendor performance, and the monitoring visit strategy.
- Proactive planning for monitoring activities to ensure data integrity, patient safety and endpoint protection.
- Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management.
- Oversight and approval of site payments, including payment reconciliation.
- Foster effective communication and collaboration with clients and cross-functional project teams in a global and multicultural environment.
- Ability to lead client-facing calls to communicate project status updates and demonstrate operational control of start-up and clinical deliverables.
- Support new business with active participation in pre-award preparation as required.
- Provides training and support to new and/or junior team members
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- University/college degree (life science preferred) or certification in a related allied health profession (nursing, medical, or laboratory technology) from an appropriately accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Fluent in English, both written and verbal
Experience (Minimum Required):
- Five or more years of relevant clinical research experience in pharmaceutical, CRO, or health care setting will be considered.
- Comprehensive knowledge of GCP, ICH, and regulatory guidelines.
- Proficiency in Microsoft Office and familiarity with EDC, CTMS, eTMF, and vendor platforms (e.g. Veeva Vault, Medidata).
- Effective leadership in remote and global environment.
- Strong communication, planning, and organizational abilities.
- Proven team motivational skills.
- Proficiency in balancing concurrent tasks within time-sensitive environments.
- Financial awareness and use of tracking systems/tools.
- Demonstrated independent problem-solving and risk management mindset.
- Demonstrated professional client interaction and presentation skills, with ability to work independently and collaboratively.
In this role, employees will leverage their existing experience and skills to assume additional responsibilities within the broader role. These will be aligned with operational requirements and internal training, without altering the fundamental nature or classification of the position.
Preferred Qualifications Include:
- Master’s or other advanced degree.
- PMP certification or equivalent.
Physical Demands / Work Environment:
- Remote-based work required with possible office presence depending on location.
- Travel requirements: up to 20% (global – primarily domestic and international)
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Originally posted on Himalayas