Clinical Project Manager
Job Description
Job #218434
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
ADDITIONAL INFORMATION
- Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
- Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
For more information, please apply or contact:
Billy James [click to reveal phone number] x340
[click to reveal email address]
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.