Clinical Trials Manager

Clinical Dynamix, Inc.; Burlington (MA); Hybride; USD 110 000 - 170 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Interpersonal skills

Communication skills

Organizational skills

Analytical mindset

Trust & credibility

Independent & teamwork

ICH-GCP knowledge

Formation

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Description du poste

Position Summary (Hybrid; 2-3 days in office)

The Clinical Trials Manager is responsible for the delivery of a key phase 3 clinical trial. This individual will contribute to the success of the team and organization by delivering high quality operational excellence on all delegated responsibilities while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement.

Key Responsibilities

• Provide strategic and operational oversight for global clinical trials.
• Support CRO and vendor management, including governance, performance tracking, and risk mitigation.
• Collaborate with internal functions (Regulatory, Medical, Biometrics, Pharmacovigilance, CMC, quality) to align on study plans and timelines.
• Monitor trial progress against key deliverables (recruitment, data quality, protocol compliance, etc).
• 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 applicable regulatory requirements.
• Support study budgets and contracts in collaboration 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 and maintain relationships with key stakeholders.
• Adhering to Company Standard Operating Procedures, Policies and applicable regulatory requirements
• Execute day-to-day responsibilities of the role, ensuring quality, accuracy, and timeliness.
• Collaborate effectively with colleagues, sharing knowledge and supporting team goals.
• Contribute to problem-solving and decision-making processes with an objective, data-driven approach.
• Communicate clearly and proactively with stakeholders to ensure alignment.
• Demonstrate ownership of tasks and follow through to successful completion.
• Support team members through constructive feedback, mentorship, and collaboration.

Skills and Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, public health, or a related field (Advanced degree preferred but not required)
• ~7 years in Clinical Operations or related function
• Strong working knowledge of ICH-GCP, and experience working on global clinical trials
• Strong interpersonal and communication skills, with the 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 with the ability to use facts and data to guide decisions.
• Ability to work both independently and collaboratively within a team.