Expert Clinical Manager

Company DescriptionArtech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job DescriptionJob Description:In collaboration with Trial Statistician, support of Reporting and Analysis Planning (RAP) modules in line with program standards.Responsible to support development of and implementation of relevant data capture tools in collaboration with CSD, GTL and AQS as documented in data handling plan or equivalent document (e.g. CRFs protocol deviations, questionnaires, diaries, translation, edit checks)Responsible for performing the ongoing review of clinical trial data as outlined in the data handling plan or equivalent , supports GTL to prepare database lock; and performing data reconciliation along the whole trila duration in collaboration with management.Collaborate with Medical Lead/BSL to identify and safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT,GCT and GPT)In collaboration with Medical Lead/BSL or CSD/CSAD, responsible for final analysis and interpretation of results including the development and drafting of clinical trial reports, publications and internal/external presentations.Provide Support for biomarkers planning and or executionMay serve on or lead global process improvement work streams or act as Subject Matter Experts for training or SOPMay support CSD in limited program level activitiesQualificationsSkills:Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization. Work experience in clinical operations preferable.Strong interpersonal skillsAbility to work under pressureExcellent negotiation and conflict resolution skillsCollaborates across boundaries for shared successResolve issues with minimal supervision and understand when to escalateThorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development processStrong analytical / computational backgroundDemonstrates excellent Medical / scientific writing skillsDemonstrates knowledge and application of statistical analysis methodology and can identify trends and analyze / interpret / report data effectivelyEducation:Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.PharmD, PhD or MD preferable.Additional InformationNeha SharmaLead RecruiterArtech Information Systems LLC360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: View phone number on us.fitly.work | Fax: 973.998.2599Website: ScienceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals