Study Manager – Infectious Disease

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Logo of Syneos Health

Syneos Health

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

• Manage interdisciplinary clinical research studies as a project manager • Ensure compliance with GCP, relevant SOPs, and regulatory requirements • Act as primary liaison between the Company and the Customer • Ensure timely study launch, conduct, and closeout • Lead project teams to ensure quality, timelines, and budget management • Manage project financial performance • Coordinate study conduct partners and manage issues • Oversee project deliverables and TMF quality and completeness • Maintain study information in databases and systems • Manage inspection readiness and project plans • Plan, coordinate, and present internal and external meetings • Prepare project management reports for clients and management • Develop contingency plans and risk mitigation strategies • Develop client relationships to generate future business • Participate in bid defense meetings as a potential project manager • May line manage project management team members and clinical monitoring staff

🎯 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

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Medical, Dental and Vision health benefits • 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) • Sick time • Company car or car allowance may be included

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