Manager, Clinical Operations

reputed company, a reputed company 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 reputed company leadership team reputed company in buying CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by reputed company in people who reputed company in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reputed company, while still offering a personalized approach to sponsors and delivering incredible value. reputed company: reputed company is looking to add a Manager, Clinical Operations (US) who can reputed company their clinical expertise and passion for analytics to reputed company 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 reputed company to candidates in the reputed company. The selected candidate will be responsible for directly managing the monitoring group and reputed company 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 reputed company teams. What You'll Do:

• Managing, supporting, and mentoring CRAs, including but not limited to reputed company reputed company 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 reputed company, and support with proposal and budget development from monitoring perspective.
• Assist in the development and implementation of reputed company for Clinical Operations and O&C as it relates to reputed company, vendor selection, and vendor management.
• Responsible for reviewing and interpreting available department and project finance dashboard data as reputed company 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 reputed company 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 reputed company-study reputed company, initiation reputed company, interim monitoring reputed company, and closeout visit as Contract allows.
• reputed company CRA reputed company reputed company to evaluate CRA performance, as needed.
• Working with Project Manager to review reputed company monitoring reports and follow-up letters in a reputed company 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 reputed company as needed.

reputed company Think You Need to be Successful in this Role:

• Previous CRA experience.
• 5+ years performing total Site Management, including on-site monitoring and managing reputed company of Clinical Research Associates.
• Experience managing CRA activities reputed company a CRO - including performance reviews. Additional experience on the sponsor reputed company extremely valuable.
• Experience using reputed company reputed company 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 reputed company and guidance to sales / reputed company teams as a subject matter expert for clinical operations.
• Working knowledge of budgets, contracting, medical terminology, federal regulations, Good Clinical reputed company, and ICH guidelines.
• Expert at MS365 apps
• Excellent communication, organization, presentation, and problem-solving skills.
• Independent decision making and high level of confidence.

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

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

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