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) 12+ years of direct Clinical Project Manager experience preferred Knowledge of FDA, ICH/GCP, and global regulatory requirements Understanding of clinical trial phases (Phase 14) 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
Job Number:
218434
Job Location:
Skaneateles, NY
Rate:
Up to $90.08 DOE
Duration:
4 months
Input Date:
05/27/2026
Firm Name:
CHIPTON ROSS
Attention:
Billy James
Address:
420 CULVER BLVD
City, State:
PLAYA DEL REY, CA 90293
Phone:
310/414-7800 X286
800 Phone:
800/927-9318
Fax Phone:
310/414-7808
Email:bjames@chiptonross.com Website:www.chiptonross.com
