高级临床试验经理（合同制）
Senior Clinical Trial Manager (Contract)
Centessa Pharmaceuticals 是艾尔建公司（Eli Lilly and Company）的全资子公司，是一家处于临床阶段的公司，正在开发一种新型药物——orexin 受体 2（OX2R）激动剂，用于治疗嗜睡症以及潜在的其他睡眠-觉醒障碍。Centessa 的主要研究候选药物——cleminorexton（原名 ORX750）正在为 1 型嗜睡症、2 型嗜睡症和特发性嗜睡症进行开发。Centessa 的 OX2R 激动剂产品线还包括其他处于临床和临床前阶段的资产，这些资产在更广泛的神经系统、神经退行性和神经精神疾病领域具有潜在应用价值。
总部位于马萨诸塞州波士顿的 Centessa 在 2026 年被认定为“最佳工作场所®”。
职位描述
Centessa 正在寻找一名（合同转正）高级临床试验经理（Sr. CTM），负责从启动到结束的全球临床试验执行及临床研究报告。该职位为临时岗位，有转为正式岗位的可能，负责试验交付，包括运营策略、时间表、预算、质量、供应商监督、风险管理及检查准备。该职位需要领导跨职能团队并管理 CRO 和外部供应商，以确保试验高效、合规地进行，并与项目目标保持一致。
主要职责
- 领导从启动到结束的全球临床试验的规划、执行和监督。
- 作为指定试验的主要运营负责人，推动跨职能团队的协调与执行。
- 制定并管理试验时间表、预算、入组预测、风险缓解计划和关键绩效指标。
- 监督 CRO 和外部供应商，确保按范围、质量标准、时间表和预算完成任务。
- 推动关键试验里程碑，包括站点启动、入组、数据库锁定和试验结束。
- 审核并批准试验方案、供应商交付物和试验文件，确保符合方案、GCP 和监管要求。
- 识别运营风险和问题，实施缓解策略，并在必要时向上级汇报。
- 主持试验团队会议，并向利益相关者和高级管理层提供定期更新。
- 确保试验主文件（TMF）在整个试验生命周期中的质量、完整性和检查准备状态。
- 支持监管提交、审计、检查和健康相关事务。
查看英文原文
Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.
Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.
Description of Role
Centessa is seeking a (contract-to-hire) Senior Clinical Trial Manager (Sr. CTM) to lead the execution of global clinical studies from startup through closeout and clinical study report. This role is a temporary position with the potential to convert to a permanent role,accountable for study delivery, including operational strategy, timelines, budget, quality, vendor oversight, risk management, and inspection readiness. This individual in this role will lead cross-functional teams and manage CROs and external vendors to ensure studies are conducted efficiently, compliantly, and in alignment with program objectives.
Key Responsibilities
- Lead the planning, execution, and oversight of global clinical trials from startup through closeout.
- Serve as the primary operational lead for assigned studies, driving cross-functional alignment and execution.
- Develop and manage study timelines, budgets, enrollment forecasts, risk mitigation plans, and key performance metrics.
- Oversee CROs and external vendors to ensure delivery against scope, quality standards, timelines, and budget.
- Drive critical study milestones, including site activation, enrollment, database lock, and study closeout.
- Review and approve study plans, vendor deliverables, and trial documentation to ensure compliance with protocol, GCP, and regulatory requirements.
- Identify operational risks and issues, implement mitigation strategies, and escalate as appropriate.
- Lead study team meetings and provide regular updates to stakeholders and senior management.
- Ensure Trial Master File (TMF) quality, completeness, and inspection readiness throughout the study lifecycle.
- Support regulatory submissions, audits, inspections, and Health Authority interactions.
- Contribute to process improvements and mentor junior clinical operations team members as needed.
- Collaborate effectively with global teams, investigators, CROs, and vendors across multiple regions.
Qualifications
- Bachelor's degree in a scientific, health-related, or equivalent discipline required.
- 8+ years of clinical research experience, including 5+ years of clinical trial management experience within a sponsor or CRO environment. 2+ years of managing Phase 1 Healthy Volunteer studies.
- Experience in standard clinical pharmacology package studies such as: First in Human, Drug to Drug Interaction, Human Absorption, Metabolism, Excretion and Mass Balance, Relative Bioavailability, Bioequivalence, Organ Impairment, Abuse Liability studies.
- Demonstrated experience independently leading Phase 1 studies, global Phase II and/or Phase III clinical trials.
- Experience managing CROs, CRUs, central vendors, and cross-functional study teams.
- Neuroscience/CNS clinical development experience preferred.
- Experience supporting inspection readiness, audits, and regulatory interactions preferred.
Compensation
The hourly range for this position is $70.00 to $100.00 per hour. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.
Contractors engaged through Centessa are employed through a third-party agency that serves as the employer of record and provides access to a comprehensive benefits package. Eligible contractors may enroll in medical plans, including PPO and EPO options, as well as dental and vision coverage after 30 days. Additional perks, such as a 401(k), wellness programs, and other discounts, may also be available to eligible contractors.
Work Location
The Senior Clinical Trial Manager role is a based in the US (Remote), with occasional travel required.
POSITION: Temporary, non-exempt
EEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
Originally posted on Himalayas