Associate Director, Clinical Development Trial Lead

Globalchannelmanagement; Indianapolis (IN); On-site; USD 150,000 - 210,000; Full time

Job summary

Globalchannelmanagement is seeking an Associate Director, Clinical Development Trial Lead to independently lead cross-functional teams through late-phase clinical trials. You will be accountable for milestones, scope, and budget while driving enrollment from country allocation to the last patient treated.

You will oversee CROs, manage the Trial Master File, ensure inspection readiness, and provide regulatory input. Travel to meetings is expected as needed.

Qualifications

• Bachelor's degree in a science or health field is required.
• 5+ years of clinical research or clinical trial experience.
• Strong working knowledge of GCP and global/regional regulations.
• Experience leading cross-functional and global trial teams and managing CROs.

Responsibilities

• Lead global and regional study teams from startup through execution and closeout.
• Own the trial timeline, scope, risks, and budget (grants and non-grants).
• Drive enrollment strategy from country allocation through last patient treated.
• Serve as the main contact for CROs and other third-party vendors; manage their selection and oversight.
• Own the Trial Master File and keep trials inspection-ready at all times.
• Detect and resolve quality issues; document deviations and issue summaries.
• Provide scientific and regulatory input for clinical documents and regulatory agency questions.
• Coach other trial leads and team members; lead process improvements.
• Travel occasionally to scientific and regional meetings.

Skills

GCP Knowledge

Leadership

CRO Management

Global Teams

Trial Oversight

Education

Bachelor's degree

Tools

Veeva

MS Project

Power BI

Excel

Critical Chain

Job description

Associate Director, Clinical Development Trial Lead for a top global pharmaceutical company. You'll independently lead cross-functional teams running complex late-phase clinical trials, and you'll be accountable for delivering milestones on time, within scope and on budget.

What you'll do:

• Lead global and regional study teams from startup through execution and closeout
• Own the trial timeline, scope, risks and budget (grants and non-grants)
• Drive enrollment strategy from country allocation through last patient treated
• Serve as the main contact for CROs and other third-party vendors; manage their selection and oversight
• Own the Trial Master File and keep trials inspection-ready at all times
• Detect and resolve quality issues; document deviations and issue summaries
• Provide scientific and regulatory input for clinical documents and regulatory agency questions
• Coach other trial leads and team members; lead process improvements
• Travel occasionally to scientific and regional meetings

Required:

• Bachelor's degree (science or health field preferred)
• 5+ years of clinical research or clinical trial experience
• Strong working knowledge of Good Clinical Practice (GCP) and global and regional regulations
• Experience leading cross-functional and global trial teams and managing CROs

Highly desired:

• Oncology trial experience (early and late phase)
• Project management tools: Veeva, MS Project, Critical Chain, Power BI, Excel
• Prior site-level or country/affiliate experience
• Proven ability to influence without authority and coach others