Expert Clinical Manager III

Ascent invests a tremendous amount of time and money to ensure that we provide value to our client and industry relationships. Our CEO often tells clients that before they select a vendor they should leverage the knowledge of their peers at other companies in the industry.

Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts. If you are ready to propel your career to new heights… read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

* Serves as Clinical Trial leader and assists other Clinical Trial Leaders. * Contributes to continuous improvement process. Prepares Clinical Trial Protocol Summaries and Clinical Trial Protocols. * Makes recommendations regarding monitoring safety, eligibility, enrollment and data consistency. * Prepares Draft Clinical Trial Reports and Draft Summaries and various registration documents. * Provides clinical research expertise in support of other departments and line functions. * Preparation and implementation of project specific training programs and training materials for internal and external staff. * Participates in multidisciplinary task forces in support of continuous improvement and other management objectives. * Demonstrates ability to write, study related procedure manuals, patient informed consents, and manuscripts. * Design clinical trials. * Outsourcing selection and management including CRPs, SMOs, central labs, and other central services as dictated by the protocol. * Design CRFs. Site selection, site management (interacts effectively with investigators and study coordinators). * Ability to assist sites with patient recruitment goals. * Draft and negotiate contracts. Identify study responsibilities (SSW) per department and per company, in-house vs. CRO. Draft clinical trial budgets. Track progress of clinical trial. * Proactive in relation to study needs, such as anticipating and meeting timelines and budgets. * Liaise with all involved departments/line units.

* University/Nursing degree required; higher degree would be preferable. * Client experience preferable, minimum of 5 years applicable experience. * Minimum of 4 yrs of relevant experience: * Global development * Data cleaning * Vendor management * Protocol and document writing * CRF set up, edit spec verification * Demonstrated written and verbal communication skills. * Medical/scientific writing skills. * Demonstrated ability to write protocols and Clinical Trial Reports. * Possess good presentation skills. * Facility with computer software in Word, Power Point and Excel. * Ability to recognize safety and efficiency data trends. * Knowledge of clinical trial design, statistics and pharmacokinetics. * Familiar with all aspects of the drug development process. * Knowledge of the medical, scientific and clinical research techniques of the assigned area. * Knowledge of GLP and local regulatory requirements. * Exhibits team leadership skills.