Clinical Project Manager – East Coast, USA | Remote

TieTalent; United States; Remote; USD 80,000 - 95,000; Full time

Job summary

An innovative firm is seeking a Clinical Project Manager to lead clinical studies in the U.S. This fully remote role offers the chance to work on groundbreaking projects in a collaborative environment. You will manage project timelines, oversee regulatory submissions, and coordinate with teams across the U.S. and Germany. With a commitment to diversity and inclusion, this position provides autonomy and flexibility, making it an exciting opportunity for professionals passionate about advancing clinical research. Join a forward-thinking team dedicated to improving patient care through digital and AI solutions.

Benefits

Paid Vacation

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

HSA

401(k) Plan

Flexible Working Hours

Collaborative Team Environment

Commitment to Diversity and Inclusion

Qualifications

• Proven experience in clinical research management.
• Strong knowledge of FDA regulations and GCP/ICH guidelines.

Responsibilities

• Oversee project planning and execution for clinical studies.
• Manage regulatory submissions and ensure compliance.

Skills

Clinical Project Management

Regulatory Submissions

GCP/ICH Knowledge

Data Privacy Regulations

Microsoft Office Proficiency

Interpersonal Skills

Analytical Skills

Education

Bachelor’s Degree in Natural Sciences

Advanced Degree (Preferred)

Tools

Electronic Data Management Systems

Databases

Job description

Clinical Project Manager – East Coast, USA | Remote

Join us at TieTalent as a Clinical Project Manager – East Coast, USA | Remote.

About Alcedis

At Alcedis, our mission is to accelerate the adoption of digital and AI in 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. We invite you to bring your expertise, passion, creativity, and dedication to help us realize this mission.

Position Overview

We are seeking a Clinical Project Manager to support our clinical operations in managing (interventional/non-interventional) clinical studies in the U.S. This is a fully remote position, ideally based on the U.S. East Coast in areas such as Boston, New York City, Philadelphia, or Washington, D.C. Other East Coast locations will also be considered. Travel is not a primary requirement but may be necessary occasionally within a project.

You will oversee clinical study activities and coordinate closely with our clinical operations team in Germany to establish our presence in the U.S.

Responsibilities

1. Oversee project planning and execution, including study start-up, ongoing management, and lifecycle coordination.
2. Handle regulatory submissions such as FDA, IRBs, Ethics Committees, INDs, CTAs, amendments, and safety reports.
3. Monitor project timelines and ensure compliance with study objectives and plans.
4. Manage project budgets, including controlling and reporting.
5. Develop and implement processes, SOPs, and documentation standards.
6. Create and manage study documents and prepare trial materials.
7. Supervise and coordinate trial sites, including communication, training, and logistics.
8. Oversee subcontractor activities.
9. Coordinate across functional teams in the U.S. and Germany.

Qualifications

• Bachelor’s degree in natural sciences or related field; advanced degree preferred.
• Proven experience as a Clinical Project Manager in clinical research, preferably in a CRO.
• Experience with IRB/ethics submissions and knowledge of data privacy regulations.
• Strong knowledge of GCP/ICH, FDA regulations, and HIPAA.
• Solution-oriented, analytical, and responsible work approach.
• Proficiency with electronic data, databases, and Microsoft Office.
• Excellent interpersonal, communication, and organizational skills.
• Fluent in English, both written and spoken.

What We Offer

• Salary: $80,000 - $95,000 annually.
• Paid vacation, health/dental/vision insurance, life insurance, HSA, 401(k).
• Innovative projects and a future-oriented environment.
• Flat hierarchies, open culture, and a collaborative team.
• Autonomy in your role with flexible working hours.
• Commitment to diversity and inclusion.

Application Process

Interested? Submit your resume and a brief cover letter via the provided link or our careers page: Alcedis Careers. For more info, visit our website: Alcedis | Digital Clinical Trials.