Manager, Clinical Operations

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November 7

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Peachtree BioResearch Solutions

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Biotechnology • Pharmaceuticals • Science

Peachtree BioResearch Solutions is a full-service Clinical Research Organization based in the United States. The company focuses on providing a solutions-based approach to small and mid-size sponsors by offering a range of services including site management, clinical monitoring, study feasibility, data management, biostatistics, project management, quality assurance, and medical writing and monitoring. Peachtree emphasizes flexibility, scalability, and reliability in its services, with experienced staff in biostatistics, data integrity, and medical trial management.

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Managing, supporting, and mentoring CRAs, including but not limited to continued oversight of CRA performance metrics including monitor visit scheduling/conduct, visit reporting, accurate time sheet entry, and compliance with Peachtree travel policy. • Partnering with Business Development/Sales to present in various business development/sales meetings, representing Peachtree monitoring resourcing and strategy, and support with proposal and budget development from monitoring perspective. • Assist in the development and implementation of strategy for Clinical Operations and O&C as it relates to contracts, vendor selection, and vendor management. • Responsible for reviewing and interpreting available department and project finance dashboard data as oversight of CRA resourcing and compliance with study specific site management and monitoring budgets, in support of project teams. • Work with Clinical Operations leadership and Finance to develop and implement budgets that will maximize profitability. • Overseeing and partaking, if needed, in the selection of sites through the Qualification and Site Eligibility processes. • Providing support to the Project Team and assuming additional roles as needed • Attending pre-study visits, initiation visits, interim monitoring visits, and closeout visit as Contract allows. • Perform CRA Oversight visits to evaluate CRA performance, as needed. • Working with Project Manager to review all monitoring reports and follow-up letters in a timely manner and ensuring that the CRAs are submitting their monitoring reports and follow-up letters per the study/Peachtree guidelines. • Attending study team teleconferences/meetings as needed. • Attending Investigator meetings and providing support as needed. • Conducting Monitor Assessment visits as needed.

🎯 Requirements

• Previous CRA experience. • 5+ years performing total Site Management, including on-site monitoring and managing a team of Clinical Research Associates. • Experience managing CRA activities within a CRO - including performance reviews. Additional experience on the sponsor side extremely valuable. • Experience using Workday Adaptive Planning or similar platform for project resourcing and headcount management; a strong understanding of project financials and resourcing impacts is a must. • Experience providing strategic insight and guidance to sales / BD teams as a subject matter expert for clinical operations. • Working knowledge of budgets, contracting, medical terminology, federal regulations, Good Clinical Practice, and ICH guidelines. • Expert at MS365 apps • Excellent communication, organization, presentation, and problem-solving skills. • Independent decision making and high level of confidence.

🏖️ Benefits

• Medical, Dental, Vision, Life, Disability coverage • 20 days PTO + PTO rollover + 13 paid holidays • 401(k)