Clinical Study Manager

At Kforce Clinical Research, we dont just offer jobs. We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the worlds most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies. Using these tools, Kforce is able to better plan and anticipate work loads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home. Currently, one of our top clients is in search of an exceptional Clinical Study Manager (CSM) in Clifton, NJ. Your leadership skills will be put to the test as the Clinical Study Manager will be responsible for the day-to-day operations of clinical trials including trial start-up, conduct, and close-out activities. Specific Accountabilities: * Lead the cross-functional Study Management Team (SMT) * Be responsible for the planning, communication, motivation, and direction of the SMT including obtaining agreement on project required timelines, study objectives, and goal-setting * Ensure accuracy and timeliness of vendor and site payments * Oversee forecasting of clinical/non-clinical supplies * Work with Pharma Development Quality Assurance to ensure that studies are conducted to appropriate levels of quality * Perform ongoing vendor management (CROs, IVRS, and Reading Centers) including independent negotiation of scope of work, budgets, performance management, and issue resolution * Create and manage clinical trial budgets and staffing/resourcing plans * Provide study-specific direction and mentoring to Clinical Site Managers, Clinical Trial Associates, and support staff as appropriate * Ensure trial adherence to ICH, GCP, and local regulations Requirements: Clinical Study Management Qualifications: * 5+ years of relevant experience through the CRO or pharmaceutical industry * 2 years at the minimum of Oncology experience; Phases I or II (preferred) * Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations * Proficient computer skills across multiple applications with an aptitude for clinical trail software Education: * For consideration, you must hold a Bachelors Degree (preferably in a scientific or health-related discipline) Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. Kforce Clinical Research has been serving the pharmaceutical industry since 1988. We are truly a career destination and the employer of choice for skilled, dedicated professionals like you. At Kforce, one of our core principles is: Great People = Great Results! This means that we will work to find you the right career match through exceptional customer service, a disciplined process, and personal respect. If you are qualified and interested in the excellent career opportunities we have for you, apply today!

Please refer to job code 1696NRC950567T199 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Clinical Research
Location:	Clifton, NJ
County:	Passaic County
ZIP Code:	07011
Pay Rate:	Open
Job Terms:	full time
Company:	Kforce Inc.
Phone:	email only please
Fax:	email only please