Expert Clinical Manager

Artech 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. 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 execution May serve on or lead global process improvement work streams or act as Subject Matter Experts for training or SOP May support CSD in limited program level activities Skills: 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 skills
• Ability to work under pressure
• Excellent negotiation and conflict resolution skills Collaborates across boundaries for shared success Resolve issues with minimal supervision and understand when to escalate Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process
• Strong analytical / computational background Demonstrates excellent Medical / scientific writing skills Demonstrates knowledge and application of statistical analysis methodology and can identify trends and analyze / interpret / report data effectively Education:
• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD,
• PhD or MD preferable. Neha Sharma
• Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: 973.967.3437 | Fax: 973.998.2599 Website: www.artechinfo.com