RTSM/eCOA Manager

Job not on LinkedIn

🔥 37 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $95k - $175.7k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements. • Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement. • Lead project team to ensure quality, timelines and budget management. • Accountable for the financial performance of each project. • Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. • Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. • Accountable for all project deliverables for each project assigned. • Responsible for quality and completeness of TMF for assigned projects. • Accountable for maintenance of study information on a variety of databases and systems. • Responsible for study management components of inspection readiness for all aspects of the study conduct. • Oversight for development and implementation of project plans. • Prepare project management reports for clients and management. • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals. • Develops strong relationships with current clients to generate new and/or add-on business for the future.

🎯 Requirements

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience. • Clinical research organization (CRO) and relevant therapeutic experience preferred. • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements • Strong organizational skills. • Strong ability to manage time and work independently. • Direct therapeutic area expertise. • Ability to embrace new technologies. • Excellent communication, presentation, interpersonal skills, both written and spoken. • Ability to travel as necessary (approximately 25%).

🏖️ Benefits

• company car or car allowance • Health benefits to include Medical, Dental and Vision • Company match 401k • eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • flexible paid time off (PTO) and sick time