Senior Clinical Medical Writer

Job not on LinkedIn

November 4

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $101.9k - $152.9k / year

⏰ Full Time

🟠 Senior

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Diabetes Youth Families

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Healthcare Insurance • Hardware

Diabetes Youth Families is a company that provides wearable insulin delivery solutions for diabetes management. Their primary products, such as the Omnipod 5 and Omnipod DASH systems, offer tubeless and automated insulin delivery for people with Type 1 and Type 2 diabetes, allowing users to manage their condition without the need for multiple daily injections. The systems integrate with continuous glucose monitoring (CGM) devices and can be controlled via compatible smartphones, enhancing the freedom and lifestyle of individuals living with diabetes. With a focus on reducing the burden of diabetes management, they offer financial assistance, support resources, and trial programs to help users adapt to their innovative solutions. The company emphasizes making life simpler while managing diabetes through technology-driven insulin management systems.

11 - 50 employees

Founded 1938

⚕️ Healthcare Insurance

🔧 Hardware

📋 Description

• Manage study startup activities such as site selection, site qualification visits, and site activation. • Prepare site initiation visit material and lead the training for protocol and case report forms for all sites. • Lead the effort for User Acceptance Testing for the study database build. • Lead the effort to draft the study-specific monitoring plan. • Review study-related documents such as protocols, consent/assent forms, etc. • Serve as the primary contact for questions related to protocol compliance throughout the study. • Conduct regular monitoring visits to ensure studies are being executed in compliance with the protocol, and applicable regulations. • Mentor other CRAs on the team. • Manage project meetings related to monitoring activities. • Lead study closeout and database lock activities. • Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.

🎯 Requirements

• B.S. or B.A. and/or an equivalent combination of education or experience. • CRA certification • Minimum of 5 years of monitoring experience. • Available to travel on short notice and independently manage travel schedules. • Direct experience in participating in the execution of clinical research studies. • Must have analytical skills, be detail-oriented and have good interpersonal skills. • Knowledge of agency guidelines and requirements.

🏖️ Benefits

• Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs