Clinical Trial Manager, Senior

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October 27

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Precision For Medicine

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Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

📋 Description

• Serves as the clinical trial lead responsible for planning, conduct and oversight of clinical studies • 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 • Identify potential risks to the enrollment targets • Develop timely and effective communication and good working relationships with investigators and study team • Lead internal clinical team meetings and sets expectations • Address all CRA and site questions • Support in planning and conducting investigator meetings • Review and/or approve of IP release packages • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies • Generate and utilize metric reporting • Responsible for eTMF implementation and management • Collaborate on corrective actions and accountability • Assist sites and staff with GCP audits • Manage processes for investigational product • Support business development and marketing activities • Negotiate site budget and contracts • Review site visit reports and monitoring plans

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field • 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 communication and interpersonal skills to effectively interface with others in a team setting • Excellent organizational skills, attention to detail, and a customer service demeanor • Ability to travel domestically and internationally including overnight stays.

🏖️ Benefits

• Health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation • discretionary annual bonus