Clinical Project Manager

25%)

Baxter Bill Rate:

$118.90~ Chipton-Ross is seeking a Clinical Project Manager for a contract opportunity in Skaneateles, NY.

BASIC QUALIFICATIONS

(REQUIRED

SKILLS/EXPERIENCE

):

• Minimum 5 years of clinical operations experience (pharma, biotech, or medical device)
• 1-2+ years of direct Clinical Project Manager experience preferred
• Knowledge of FDA, ICH/GCP, and global regulatory requirements
• Understanding of clinical trial phases (Phase 1-4)
• Experience with clinical systems (EDC, CTMS, eTMF)
• Strong project management skills
• Knowledge of arrhythmias, ECG interpretation, or ambulatory cardiac monitoring systems
• Ability to interpret diagnostic performance metrics (e.g., sensitivity, specificity, PPV/NPV) and translate findings into clinical insights
• Experience assessing risk/benefit and clinical implications of algorithm performance differences
• Familiarity with algorithm-based diagnostics or AI/ML-driven medical devices
• Understanding of validation requirements for medical devices (e.

g., EU

MDR, FDA

expectations)

POSITION RESPONSIBILITIES

• Partner with relevant client functions to develop clinical study plan for each project including timelines and budgets for the clinical program.
• Prepare directly or facilitate preparation of study documentation including protocols, case report forms, informed consent, enrolment feasibility evaluations and all relevant internal plans required for study conduct.
• CRO management (when applicable): Lead the day-to-day oversight of the CRO personnel plus the project budget, deliverables and timeline/milestones.
• Site activities (either directly or managing others): Identify and assess study sites, conduct investigator meetings and site training, prepare and execute research agreements and negotiate study budgets.
• Study monitoring (either directly or managing others): Formulate clinical monitoring plan, perform study initiation visits, manage clinical study monitoring resources, oversee standard interim monitoring visits and closeout activities
• Perform study closeout procedures, directly or through other resources, including accurate completion of critical documents, disposition of study product and preparation of study sites for regulatory authority audits.
• Develop and maintain tracking systems as needed for study management, e.

g. screening, enrolment, study completion, (serious) adverse events, budgets and forecasts, milestones.

REQUIRED EDUCATION

• Accredited Bachelor's degree in a scientific field

WORK HOURS

• Full-Time
• 1st Shift