Unlock your potential at Alcedis
At Alcedis, you will be part of our mission to accelerate the adoption of digital and AI across research & care. As a trusted partner to biotechs, pharma, and academia, we integrate cutting-edge technology into clinical trials to advance drug development and patient care. Join us, and bring your expertise, passion, creativity and strong willingness for success to realize this mission.
We are looking for a Clinical Project Manager to support our clinical operations department in the management of (interventional/non-interventional) clinical studies in the U.S.. This is a 100% remote position, but we are looking for candidates based on the U.S. East Coast, ideally in or around major metropolitan areas such as Boston, New York City, Philadelphia, or Washington, D.C. Other East Coast locations will also be considered. Travel is not primarily planned but may be a necessary option within a project and cannot be ruled out.
You will be responsible for clinical study activities and will be in close contact with the clinical operations team at Alcedis, Germany to establish the location in the United States.
Responsibilities
- Oversee project planning and execution, including study start-up activities, ongoing study management, and coordination at all stages of the clinical trial lifecycle
- Manage regulatory notifications and approval processes, ensuring submission of applications in compliance with national requirements
- Monitor project timelines and ensure adherence to the Project Plan, maintaining compliance with study objectives
- Project budget responsibility and project budget controlling, reporting to the functional unit head
- Develop and implement processes, SOPs, work instructions, and standardized documentation to ensure consistency and compliance
- Creation and management of study documents (e.g., Trial Master File) and preparation of trials (site contract management, creation of print materials, organization of trial material, organization of trial meetings, etc.)
- Supervise and coordinate trial sites, including communication, training, document shipping and tracking, and payment processing
- Coordination of monitoring activities, including review of monitoring reports
- Supervision and coordination of subcontractor activities
- Coordination of the project team across the various functional units and national borders (USA-Germany)
Qualifications and requirements
From day one, we expect you to bring:
- A Bachelor’s degree in natural sciences, a related field, or an equivalent qualification—ideally with a medical focus; an advanced degree is preferred
- A minimum of 5 years of experience in clinical research, monitoring, or project management within the pharmaceutical, biotech, or CRO industry
- Hands-on experience with IRB/ethics committee submissions, as well as knowledge of data privacy and protection regulations
- Strong working knowledge of GCP/ICH guidelines, principles of observational research, FDA regulations, and HIPAA compliance
- An analytical, solution-oriented, and accountable approach to work
- Proficiency in working with electronic data and databases, along with solid skills in Microsoft Office applications
- Strong interpersonal skills and a collaborative team mindset
- The ability to work independently, proactively, and with strong planning and execution skills
- Excellent communication and organizational skills
- Fluency in English, both written and spoken
What we can offer you
- $80,000 - $95,000 a year
- 15 paid vacation days
- Health, dental and vision insurance for you and your dependents
- Employee life insurance
- Health Savings Account (HSA)
- 401(K)
- You'll work in a future-oriented and secure working environment
- You can expect exciting and challenging projects
- With us you will find flat hierarchies combined with an open corporate culture
- You can expect a successful, committed and open team
- You’ll enjoy a varied role with the autonomy to work independently and take responsibility for your projects
- We value a pleasant working atmosphere in a successful and growing company
- Flexible working hours are an integral part of our work culture
At Alcedis, we believe that diversity and inclusion drive innovation and success. We welcome applicants of all backgrounds and do not discriminate based on race, ethnicity, gender, sexual orientation, disability, age, religion, or any other protected characteristic.
