Clinical Trial Manager – Senior Clinical Trial Manager

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October 27

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Precision Medicine Group

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Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

📋 Description

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work • Ensure that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents • Identify and develop training needs for CRAs and third-party vendors • Generate potential site list from key stakeholders and drive site feasibility process • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies • Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA)

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred • Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) • Excellent organizational skills, attention to detail, and a customer service demeanor • Ability to travel domestically and internationally including overnight stays

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation