临床试验经理, III 类医疗器械
Clinical Trial Manager, Class III Medical Devices
**关于该职位：**
作为临床试验经理，您将负责对III类医疗设备的临床试验进行规划、协调和执行，确保其符合监管和质量标准。您将加入可植入设备单元团队，与跨职能合作伙伴、研究现场和外部供应商紧密合作，以支持有效的试验运作。您的角色对于跟踪研究进展、识别操作风险以及解决影响时间表和数据质量的问题至关重要。您将支持试验文档、供应商监督和现场管理流程，在设备临床总监的领导下发挥关键作用，推动成功完成临床试验。该职位提供了一个机会，通过确保III类医疗设备的安全性和有效性来影响整体业务，从而提升患者护理。
**您将负责：**
- 管理III类医疗设备临床试验的日常执行和协调。
- 与跨职能团队成员合作，跟踪研究活动、时间表、交付成果和操作问题。
- 与研究现场、CRO和为III类医疗设备试验提供支持的外部供应商协调，确保按照时间表和质量期望执行协议要求的活动。
- 监控III类医疗设备临床试验的进展和操作指标，识别可能影响时间表和数据质量的风险和问题。
- 通过审查表现和操作质量问题，支持III类医疗设备临床试验的供应商监督和现场管理。
- 与内部利益相关者如安全、法规、质量和数据管理团队合作。
- 协助文档、供应商监督活动和现场管理流程。
- 在内部团队成员、CRO和现场之间促进沟通，以保持研究的连续性。
- 支持法规提交、方案修订和安全报告流程。
- 组织并跟踪III类医疗设备临床试验的随访活动，如行动项日志和问题跟踪器。
**您具备：**
您是一位具有III类医疗设备经验的临床试验专业人员，能够在注重细节和组织能力的动态环境中茁壮成长。您热衷于确保III类医疗设备临床试验的成功和安全。
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**About This Role:**
As a Clinical Trial Manager, you will be integral to the planning, coordination, and execution of clinical trials for Class III medical devices, ensuring they are conducted in compliance with regulatory and quality standards. You will be part of the Implantable Device Unit team, working closely with cross-functional partners, study sites, and external vendors to support effective trial operations. Your role is crucial for tracking study progress, identifying operational risks, and contributing to the resolution of issues affecting timelines and data quality. You will support trial documentation, vendor oversight, and site management processes, playing a key role in delivering successful clinical trials under the leadership of the Director, Device Clinical. This position offers an opportunity to impact the overall business by ensuring the safety and efficacy of class III medical devices that enhance patient care.
**What You’ll Do:**
- Manage day-to-day execution and coordination of clinical trials for Class III medical devices.
- Track study activities, timelines, deliverables, and operational issues in partnership with cross-functional team members.
- Coordinate with study sites, CROs, and external vendors supporting class III medical device trials to ensure protocol-required activities are performed according to timelines and quality expectations.
- Monitor study progress and operational metrics for class III medical device trials, identifying risks and issues that may affect timelines and data quality.
- Support vendor oversight and site management for class III medical device clinical trials by reviewing performance and operational quality concerns.
- Collaborate with internal stakeholders such as Safety, Regulatory, Quality, and Data Management teams.
- Assist with documentation, vendor oversight activities, and site management processes.
- Facilitate communication among internal team members, CROs, and sites to maintain study continuity.
- Support regulatory submissions, protocol amendments, and safety reporting workflows.
- Organize and track class III medical device clinical trial follow-up activities like action item logs and issue trackers.
**Who You Are:**
You are clinical trial professional with class III medical device expertise who thrives in a dynamic environment where attention to detail and organizational skills are paramount. You have a passion for ensuring the success and safety of class III medical device clinical trials, with the ability to navigate complex issues and coordinate multiple stakeholders effectively. Your proactive nature and excellent communication skills help you manage competing priorities and tight timelines with grace and efficiency. You are committed to fostering collaboration and maintaining high standards of quality and compliance in every aspect of trial management.
**Required Skills:**
- Bachelor’s degree; advanced degree preferred.
- At least 5 years of experience in clinical research or clinical operations.
- Experience supporting clinical trials for Class III implantable medical devices.
- Strong organizational and communication skills.
- Ability to track study progress and identify operational risks.
- Knowledge of regulatory and quality standards in clinical trials.
- Experience with vendor oversight and site management.
- Familiarity with regulatory submissions and protocol amendments.
- Expertise in safety reporting workflows and managing study changes.
Job Level: Management
**Additional Information**
The base compensation range for this role is: $117,000.00-$156,750.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families _physical, financial, emotional,_ and _social well-being_; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
**Why Biogen?**
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. [Read on](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.biogen.com%2Fresponsibility%2Fdiversity-inclusion.html&data=05%7C01%7Cdennis.mercier%40biogen.com%7C67adaf5a6edd4324716208db0dcd2182%7C7b7466bbfe1d47a0b9438ded565c8e54%7C0%7C0%7C638118946897044815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX04%3D&reserved=0) to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.