Associate Study Start-Up Manager

🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🗽 New York, North Carolina, +1 more states – Remote

🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote

💵 $60.3k - $157.1k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Direct and manage delivery of required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs • Oversee Site Activation, including pre-award/bid defense activities, and/or Maintenance for assigned projects according to strategy and timelines • Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan • Resolve project-related issues as required • Collaborate across Regulatory & Site Activation, including communication with regions and countries • Create and/or review technical and administrative documentation supporting business development, study initiation, and maintenance • Provide specialist regulatory and technical scientific support for business development, initiation, and maintenance of clinical trials • Provide guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance • Determine regulatory strategy, expectations, and parameters for submissions and authorizations • Identify regulatory complexity and challenges and develop practical solutions supporting the bid process and site activation plan • Assess the regulatory landscape and contribute to regulatory intelligence collection, analysis, interpretation, and dissemination • Execute operational strategy for maintaining clinical study approvals and authorizations • Review and negotiate contracts and essential documents • Work with Quality Management to ensure quality standards throughout site activation or maintenance • Mentor and coach colleagues • Maintain internal systems, CTMS, databases, tracking tools, timelines, and project plans • Develop long-standing relationships with preferred IQVIA customers • Deliver presentations and training to clients, colleagues, and professional bodies • Participate in monthly study budget planning and reviews

🎯 Requirements

• Bachelor's Degree in Life sciences or related field required • 7 years’ relevant experience in a scientific or clinical environment, including demonstrable experience in an international role • Equivalent combination of education, training and experience • Strong negotiation and communication skills with ability to challenge • Excellent interpersonal skills and strong team player • Proven ability to work through others to deliver results to appropriate quality and timeline metrics on complex projects • Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process • Demonstrated proficiency in using systems and technology to achieve work objectives • Good regulatory and/or technical writing skills • Strong knowledge and ability to apply GCP, ICH guidelines, and applicable regulatory guidelines • Good leadership skills, with ability to motivate, coach and mentor • Good organizational and planning skills • Ability to exercise independent judgment and take calculated risks when making decisions • Good presentation skills • Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors • Excellent understanding of study financial management • Proven ability to work on multiple projects while balancing competing priorities

🏖️ Benefits

• Health and welfare benefits • Incentive plans, bonuses, and/or other forms of compensation may be offered