Clinical Project Manager

Stark Pharma; Town of Skaneateles (NY); Vor Ort; USD 90.000 - 120.000; Teilzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Clinical research experience

Project management

Clinical trial phases knowledge

FDA and ICH/GCP knowledge

Interpreting diagnostic performance metrics

Ausbildung

Bachelor's degree in a scientific field

Tools

Clinical systems (EDC, CTMS, eTMF)

Jobbeschreibung

Overview

Job title: Clinical Project Manager

Location: Skaneateles, NY

Duration: 4 Months

Summary

Responsible for managing the organization and conduct of clinical studies in compliance with Clinical Operations policies and procedures, Regulatory (Health) Authority requirements and guidelines, and International Conference on Harmonization (ICH) Guidelines in support of global business objectives.

Reports directly to Sr. Director of Medical Affairs. The Clinical Project Manager plans for and executes the required global or domestic clinical development plan of drugs and devices to generate data to support the launch and expansion of critical treatments for patients. This data serves to globally support regulatory submissions, post-marketing complaint handling and promotional claims for marketing strategies.

This role also partners cross-functionally with regulatory, engineering, marketing, sales, and research teams to support problem-solving and decision-making efforts.

Top Skills Needed

• 4-5 years of clinical research experience, including 1-2+ years as a Clinical Project Manager
• Proactive, collaborative, and self-driven with a take-charge attitude
• End-to-end clinical study experience (site selection, contracting, execution, and closeout)

Essential Duties And Responsibilities

• Partner with relevant Baxter 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.

Qualifications, Education, And Experience

• Bachelor's degree in a scientific field
• 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)