Global Clinical Project Manager (Pharma & Devices)

Stark Pharma; Town of Skaneateles (NY); On-site; USD 90,000 - 120,000; Part time

Job summary

Stark Pharma is looking for a Clinical Project Manager to manage the organization and conduct of clinical studies in compliance with regulatory requirements. Located in Skaneateles, NY, this role is pivotal in supporting global business objectives by generating data for drug and device launches.

Responsibilities include developing study plans, overseeing CROs, and managing site activities. The ideal candidate will have at least 5 years in clinical operations, including direct project management experience.

Qualifications

• Minimum 5 years of clinical operations experience in pharma, biotech, or medical device.
• 1-2+ years of direct Clinical Project Manager experience preferred.
• Knowledge of FDA, ICH/GCP, and global regulatory requirements.

Responsibilities

• Manage clinical studies in compliance with policies and guidelines.
• Develop clinical study plans including timelines and budgets.
• Lead day-to-day oversight of CRO personnel and project deliverables.

Skills

Clinical research experience

Project management

Clinical trial phases knowledge

FDA and ICH/GCP knowledge

Interpreting diagnostic performance metrics

Education

Bachelor's degree in a scientific field

Tools

Clinical systems (EDC, CTMS, eTMF)

Job description

Stark Pharma is looking for a Clinical Project Manager to manage the organization and conduct of clinical studies in compliance with regulatory requirements. Located in Skaneateles, NY, this role is pivotal in supporting global business objectives by generating data for drug and device launches.

Responsibilities include developing study plans, overseeing CROs, and managing site activities. The ideal candidate will have at least 5 years in clinical operations, including direct project management experience.