Senior Clinical Trial Manager

We're Hiring: Associate Director, Clinical Development Trial Lead (CDTL)

Job Title: Associate Director, Clinical Development Trial Lead (CDTL)

Industry: Pharmaceutical / Clinical Research

Work Location: Remote

Travel: Periodic travel required for scientific and regional meetings

Pay Range: $95 to $104 hourly on W2

Must required - Phase 3 / III exp or Late phase

Position Overview

We are seeking an experienced Associate Director, Clinical Development Trial Lead (CDTL) to provide strategic leadership and oversight for complex clinical trials across regional and global programs.

The individual will independently lead cross-functional study teams, drive clinical trial planning and execution, and ensure the successful delivery of clinical milestones within established timelines, budgets, scope, and quality standards.

This role requires strong clinical development expertise, project management capabilities, and the ability to influence cross-functional stakeholders, manage complex trial-related challenges, and drive operational excellence. Experience in oncology clinical trials, including early- and late-phase studies, is highly desirable.

Key Responsibilities

• Lead and oversee complex global, regional, and local clinical trials, ensuring successful execution from study initiation through completion.
• Drive cross-functional study teams, collaborating with Clinical Operations, Medical, Regulatory, Biostatistics, Data Management, vendors, CROs, and regional affiliates.
• Develop, monitor, and manage integrated clinical trial plans, including scope, timelines, enrollment strategies, budgets, and risk mitigation activities.
• Drive global and regional enrollment strategies, working closely with regional operations teams to achieve enrollment targets through Last Patient Entered Treatment (LPET).
• Provide strategic oversight of clinical trial execution, proactively identifying operational challenges, resolving issues, and implementing contingency plans.
• Ensure Trial Master File (TMF) completeness, accuracy, and inspection readiness throughout the clinical trial lifecycle.
• Maintain compliance with Good Clinical Practice (GCP), applicable global and regional regulatory requirements, and organizational quality standards.
• Identify, assess, and mitigate trial-level risks while independently managing quality issues, deviations, and process gaps.
• Manage CRO and Third-Party Organization (TPO) relationships, including qualification, selection, oversight, and delivery of clinical trial milestones.
• Partner with regional and global stakeholders to facilitate investigator and affiliate study-specific training.
• Drive continuous improvement initiatives, develop new clinical trial processes, and contribute to the implementation of operational tools and methodologies.
• Provide coaching, mentoring, and subject matter expertise to Clinical Development Trial Leads (CDTLs) and cross-functional team members.
• Support the preparation and review of clinical and regulatory documents, regulatory agency meeting preparation, and responses to regulatory inquiries.

Required Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline.
• Minimum of 5 years of clinical research, clinical trial management, or relevant scientific/healthcare experience.
• Strong working knowledge of the clinical research and drug development processes.
• Demonstrated experience leading or supporting cross-functional clinical trial teams.
• Experience with clinical trial planning, project management, risk assessment, enrollment management, and budget oversight.
• Strong understanding of GCP, global clinical trial regulations, and regional/country-specific requirements.
• Excellent communication, organizational, analytical, problem-solving, and stakeholder management skills.

Highly Preferred Qualifications

• Experience in Oncology clinical trials, including both early- and late-phase studies.
• Previous clinical trial site-level, regional affiliate, or country-level clinical operations experience.
• Demonstrated ability to lead global and cross-cultural teams and collaborate with CROs, vendors, and Third-Party Organizations (TPOs).
• Proven ability to influence stakeholders without direct authority and independently drive complex clinical trial decisions.
• Experience coaching, mentoring, and developing clinical operations professionals.
• Strong knowledge of Trial Master File (TMF) management and clinical trial inspection readiness.
• Proficiency with clinical trial and project management tools such as Veeva, MS Project, MS Excel, PowerPoint, and Power BI.
• Ability to navigate complex situations, manage competing priorities, and drive continuous process improvements.