Clinical Data Management Project Manager

Job description

The Data Management Project Manager is responsible for developing and implementing project plans for outsourced studies, ensuring that the activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial, by acting as the primary Data Management (DM) representative to the study management team. The DMPM ensures projects are appropriately resourced and proposes solutions for data management issues that arise during the course of a study. Minimum of 5 years in the Data Management field, previous work with CROs and Data Management vendors is required, working in a global/cross-cultural setting is preferred In-depth knowledge and understanding of the drug development process and data management process. Aware of related Pharma Industry SOPs, guidelines and Best Practices Knowledge of GCP and other regulations. Aware of current global regulatory guidelines relevant to Clinical Data Management. Technical/Software Skills: Familiarity with Oracle Clinical or other clinical data management system software; General software skills: Lotus Notes, MS Access, MS Word, MS Excel, MS Project Strong understanding of database programming concepts. Excellent multi-level, oral and written communication skills and presentation skills. Ability to manage multiple programs and processes simultaneously. Proven ability to build relationships and manage expectations with CROs and key Data Management service providers who represent single or multiple functions. Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem solving ability, resource planning, ability to develop trust, shared goals and values. Exhibits collaborative, conceptual thinking, systems process thinking, accountability to deliverables milestones, conflict resolution (internal and external). Demonstrates leadership, negotiation and problem-solving The candidate should be detail oriented, identify issues and assist in problem solving in a timely manner. Education College Degree All your information will be kept confidential according to EEO guidelines. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. With todays growing demand for talented and well qualified professionals, its more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth. IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ. We have been honored by the following: Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009 Top 500 Privately-Held Business in the US Top 500 Diversity Owned Business in the US Top 100 Subcontinent Asian American Business in the US We have also been listed to the Inc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010 and honored as an Emerging Business of the Year finalist by NJ BIZ in 2009.