Job Details

Manager, Clinical Operations

Peachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a pharma leadership team experienced in buying CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reach, while still offering a personalized approach to sponsors and delivering incredible value.

Summary: Peachtree BioResearch Solutions is looking to add a Manager, Clinical Operations (US) who can leverage their clinical expertise and passion for analytics to lead site management and start-up activities to guarantee sponsor satisfaction. This person will report to the Global Director, Clinical Operations and is a fully remote position open to candidates in the United States. The selected candidate will be responsible for directly managing the monitoring group and oversight will include full-time employees and contractors. Additionally, the Mgr, Clinical Operations will play a critical role in providing clinical operations and site management expertise to our sales and contracts teams.

What You'll Do:

• 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 visits 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.

What We Think You Need to be Successful in this Role:

• 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.

In addition to working with great people on high performing teams, full-time employees receive:

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