
1001 - 5000 employees
🏥 Healthcare
💼 Consulting
🧬 Biotechnology
💰 Venture Round on 2016-10
Healthcare • Consulting • Biotechnology
Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.
🔥 2 minutes ago
🌐 United States, France, +3 more countries – Remote
💵 $116k / year
⏰ Full Time
🟠 Senior
🦅 H1B Visa Sponsor
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1001 - 5000 employees
🏥 Healthcare
💼 Consulting
🧬 Biotechnology
💰 Venture Round on 2016-10
Healthcare • Consulting • Biotechnology
Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.
• Coordinate and collaborate with functional leads to deliver site activation • Organize and oversee strategic efforts for quality and efficient site activation delivery according to contractual obligations • Lead Site ID Kick Off Meetings and attend internal and external kick-off meetings • Understand client objectives, timelines, and study start-up strategy; review study budget and start-up scope • Oversee SSU and clinical activation deliveries in alignment with project timelines and strategy • Update Premier Predict/study projections through site activation • Collaborate with Project Strategist, Medical Informatics, Medical Affairs, PM, RSMs, CLs, and SSU Country Leads to finalize country mix and site selection • Escalate and track risks to PM and Sponsor and identify mitigation strategies • Use data to drive decisions, next steps, and team communication • Propose proactive solutions for risks or issues affecting site activation delivery • Oversee and support CTMS data entry through site activation to ensure data quality • Provide rationale for delays and contingency plans when forecasted timelines are not achieved • Monitor and analyze project/program site activation status and provide metrics • Provide progress updates to internal teams, clients, and upper management during weekly teleconferences and as needed
• Undergraduate degree or its international equivalent in clinical, science, or a health-related field from an accredited institution is preferred • Licensed health-care professional is preferred • 5 years professional experience as a CL, RSM, PM, SSUA, or equivalent • Demonstrated ability in leadership of a team of individuals in study start-up and across other functions • Understanding of project financial aspects and adherence to project timelines and study budget • Excellent interpersonal skills and ability to collaborate and build an effective team • Comfortable in customer-facing meetings such as Bid Defense Meetings • Excellent organizational, time-management, presentation, technical, and written/verbal communication skills • Strong knowledge of ICH/GCP regulations
• Comprehensive benefits package, which may include health insurance, retirement plans, and paid time off • Flexibility and balance to support your life requirements • Skills and opportunities to excel at work
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