Senior Clinical Trial Program Lead

TMH The Miriam Hospital; United States; On-site; USD 82,000 - 136,000; Full time

Job summary

The Miriam Hospital is seeking a Clinical Trial Program Manager to lead initiation and execution of clinical trials, ensuring compliance with ICH-GCP, FDA, EMA, and institutional SOPs. Responsibilities include site identification, activation, contract negotiation, budgeting, and regulatory submissions.

You will mentor a team of study nurses, coordinators, and assistants, coordinate with CROs and vendors, and provide regular updates to senior management.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field required.
• Strong knowledge of clinical trial processes and regulatory standards (ICH-GCP, FDA, EMA).
• Experience with study start-up, regulatory submissions, site identification, feasibility, and contract negotiation.
• Mentoring and team management skills; excellent organizational and communication abilities.

Responsibilities

• Oversee study initiation, site identification, feasibility, and IRB submissions.
• Develop timelines and budgets; ensure activities stay on time and within budget.
• Lead contracts and budgets; coordinate with legal, procurement, and vendors.
• Mentor and supervise study nurses, coordinators, and assistants; provide training.

Skills

CTMS experience

Regulatory compliance

Contract negotiation

Leadership

Project management

Education

Bachelor’s degree in Life Sciences

Master’s degree preferred

Tools

CTMS software

Microsoft Office

Regulatory submission software

Job description

The Miriam Hospital is seeking a Clinical Trial Program Manager to lead initiation and execution of clinical trials, ensuring compliance with ICH-GCP, FDA, EMA, and institutional SOPs. Responsibilities include site identification, activation, contract negotiation, budgeting, and regulatory submissions.

You will mentor a team of study nurses, coordinators, and assistants, coordinate with CROs and vendors, and provide regular updates to senior management.