Clinical Project Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $120k - $165k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 0%

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Baxter International Inc.

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 Grant on 2021-04

Healthcare • Manufacturing • Healthcare Insurance

Baxter International Inc. is an innovative, global healthcare leader that offers advanced products, technologies, and therapies to support people in leading healthier, longer lives. The company is committed to meeting the challenges faced by patients, clinicians, and customers in the evolving healthcare landscape, emphasizing resilience and a mission to save and sustain lives.

📋 Description

• Independently manage assigned clinical trials across the study lifecycle, from protocol development and site selection through study completion, database lock and final clinical study report review • Manage all aspects of clinical trials, including protocol creation, site selection, vendor selection, database lock and final clinical study report review • Prepare or facilitate preparation of protocols, case report forms, informed consent, enrollment feasibility evaluations and study conduct plans • Manage interfaces with Legal, Research and Development, Data Management, Medical Writing, Medical Affairs, Clinical Compliance and Training, Regulatory, and Marketing • Provide updates to senior management and escalate issues • Manage external team and vendor activities, including IRBs, and coordinate study site team members, physicians and research staff • Identify and assess study sites, conduct investigator meetings and site trainings, prepare and execute research agreements, and negotiate study budgets • Develop and maintain study management tracking systems for screening, enrollment, study completion, adverse events, budgets, forecasts and milestones • Partner with internal stakeholders, clinical sites and external vendors to ensure quality, compliance, efficiency and accountability

🎯 Requirements

• Bachelor’s degree in clinical research, biostatistics, pharmacy, nursing or a related healthcare discipline, or equivalent experience required • 3–5 years of experience in clinical research, with increasing responsibility in trial coordination, clinical development, protocol management or clinical project management • Experience supporting multi-site clinical trials • Experience managing external vendors • Experience ensuring compliance with applicable regulatory requirements • Working knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA and EMA regulations, and applicable clinical trial requirements • Understanding of statistical principles, including concepts described in ICH E9, and their application in clinical study design and data interpretation • Knowledge of clinical study design, endpoints, protocols and regulatory documentation requirements • Strong project management skills, including scope definition, scheduling, budgeting, risk management and key performance indicator tracking • Experience coordinating with sponsors, contract research organizations, investigators, study sites, regulatory stakeholders and internal cross-functional teams

🏖️ Benefits

• Medical and dental coverage starting on day one • Basic life, accident, short-term disability, long-term disability, and business travel accident insurance • Employee Stock Purchase Plan (ESPP), with ability to purchase company stock at a discount • 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching • Flexible Spending Accounts • Educational assistance programs • Paid holidays • Paid time off ranging from 20 to 35 days based on length of service • Family and medical leaves of absence • Paid parental leave • Commuting benefits • Employee Discount Program • Employee Assistance Program (EAP) • Childcare benefits • Reasonable accommodations for individuals with disabilities