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Study Manager: Smith Hanley Consulting - Pharmaceuticals
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Excellent career opportunity for a Study Manager in NC for a top Fortune 500 Company!
Therapeutic area - Respiratory group. Accountable to ensure all relevant studies follow SOPs and GCP. Assist with maintaining relationships and monitor performance of CROs and other vendors. With direction from Senior Operations Staff, collaborate with Clin Ops functional groups (US Monitoring, Data Management, and Ops Management) to ensure on time delivery of studies. Proactively track timelines; identify issues & propose strategies to implement contingencies and risk planning to meet overall study goals. Manage study start-up, conduct & close-out. Manage and forecast clinical trial material. Manage clinical trial budgets to include: develop initial budget, review invoices, manage monthly accruals, utilize existing tools to benchmark and manage study costs, review and update monthly budget phasing (spend), provide explanation for budget variances, develop and retain budget assumptions. Assist in the management of CROs or other outsourcing partners as appropriate Provide input into content & execution of investigator meetings - may present selected topics. May also be asked to manage executiion of the investigator meeting. Coordinate presentation materials from cross functional areas for PI meetings. Provide input into development of CRF. Provide input into site selection. Review and approve country/site start up & patient recruitment plans. Manage collection of operational feasibility for study design Keep internal tracking systems accurate & up to date; extract and use data to manage assigned studies Experience setting up contracts with & managing electronic data capture tools and/or systems (eCRF, eDiary, etc.) Previous experience managing vendors. Skills: Communication- oral and written Resilience Flexibility, Adaptability Initiative Team player Ability to work in environment with multiple priorities and frequent changes Technical Skills: 4 year degree preferred Computer skills proficiency (LN, MS Word Suit Study Manager - (1DEG) Exp managing vendors. 4 yr degree preferred. Manage clinical trial budgets. Manage study start-up, conduct & close-out. When you work for Smith Hanley Consulting Group, you are partnering with a leader in clinical trials and scientific staffing. For over two decades, we have built solid and successful relationships with top pharmaceutical companies across the USA. Our recruiters are committed to finding you the perfect job, allowing you to build and diversify your experience. We are dedicated to understanding your skills and career goals inside out. Smith Hanley Consulting offers competitive salaries and immediate medical/dental coverage. In addition, our benefit package includes life insurance, long-term disability and a 401(k) retirement plan with an employer match. For out of state contracts, we provide relocation assistance and per diem. We even pay for work Visas and offer Green Card sponsorships. So come join the clinical consultant’s employer of choice. What are you waiting for? Apply today!
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