Global Clinical Trials Manager — Hybrid Lead, Phase 3

Clinical Dynamix, Inc.; Burlington (MA); Hybrid; USD 110,000 - 170,000; Full time

Job summary

Clinical Dynamix, Inc. is seeking a Clinical Trials Manager to lead a key phase 3 trial in a hybrid model (2–3 days in office). You will oversee global trials, coordinate with regulatory, medical, and quality teams, and ensure protocol adherence and data quality.

Responsibilities include site startup, budget support, audits, and stakeholder communication. The role requires ~7 years in clinical operations, strong ICH-GCP knowledge, and excellent organizational and communication skills.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, public health, or related field; advanced degree preferred but not required.
• ~7 years in Clinical Operations or related function.
• Strong working knowledge of ICH-GCP and experience on global clinical trials.
• Strong interpersonal and communication skills; ability to adapt to different audiences.
• Excellent organizational skills.
• Proven ability to build trust and credibility through integrity, openness and respect.
• Demonstrated accountability in delivering results and meeting commitments.
• Analytical mindset; use data to guide decisions.
• Ability to work independently and collaboratively within a team.

Responsibilities

• Provide strategic and operational oversight for global clinical trials.
• Support CRO and vendor management, including governance, performance tracking, and risk mitigation.
• Collaborate with Regulatory, Medical, Biometrics, Pharmacovigilance, CMC, quality to align on study plans and timelines.
• Monitor trial progress against key deliverables (recruitment, data quality, protocol compliance).
• Review, drive essential trial documents (protocols, ICFs, plans, manuals).
• Support country and site selection, start-up activities, and site engagement strategy.
• Manage and support sites in study maintenance for a fast-enrolling trial.
• Ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
• Support study budgets and contracts with finance and legal teams.
• Contribute to clinical development strategy and operational planning.
• Prepare for and participate in study audits, inspections and data deliverables.
• Attend Site Investigator Visits and build relationships with stakeholders.
• Adhere to SOPs, policies and regulatory requirements.
• Execute day-to-day responsibilities with quality, accuracy, timeliness.
• Collaborate with colleagues, share knowledge and support team goals.
• Contribute to problem-solving and data-driven decisions.
• Communicate clearly with stakeholders to ensure alignment.
• Demonstrate ownership of tasks and follow-through.
• Mentor and support team members.

Skills

Interpersonal skills

Communication skills

Organizational skills

Analytical mindset

Trust & credibility

Independent & teamwork

ICH-GCP knowledge

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Job description

Clinical Dynamix, Inc. is seeking a Clinical Trials Manager to lead a key phase 3 trial in a hybrid model (2–3 days in office). You will oversee global trials, coordinate with regulatory, medical, and quality teams, and ensure protocol adherence and data quality.

Responsibilities include site startup, budget support, audits, and stakeholder communication. The role requires ~7 years in clinical operations, strong ICH-GCP knowledge, and excellent organizational and communication skills.