Senior Contract CRA/Contract Clinical Project Manager

Senior Contract CRA  orContract Clinical Project ManagerOur client is a leader in the field of RNA interference and is rapidly growing company of 150 with plans to expand to 170 by Q4 2008. The company was founded by scientific pioneers in the field of RNAi and has assembled a management team with significant product development experience. They are building a deep pipeline of RNAi therapeutics to treat a wide range of diseases and are currently looking for a Director/Associate Director Regulatory Affairs to lead their regulatory team.  If you are interested in this exciting ‘new’ field and would like high visibility within a smaller organization, please take a look… Responsibilities  Responsible for all aspects of clinical study planning and execution within pre-specified program plan, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors especially CRO, supervision of study related activities, identification of project risks and contingency planning. Manage integrations of all project team activities. Execution of a clinical development program from protocol design to the final clinical study report for specified studies. Manage all aspect of contract research organization selection, and the day to day study management activities of contract research organizations Manage study sites and tracking systems for regulatory documents, CROP monitor visit reports and site correspondence, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, financial information, Serious Adverse Events, performance metrics, data flow, etc. CRF and ICF review. Coordinate all efforts for the trial both within the company and through a wide variety of CRO and vendors. Participate in discussion and help develop contingency/risk management plans for projects and assist Manager, Clinical Operations and/or Senior Director of Clinical Operations in the preparation and execution of sound development strategies. Track and manage project actual costs vs. budget (keep track of specific items/details in the budget and know whether expenses are on target). Interface with Finance which may include acting as a liaison between Clinical and Finance. Budget and forecast preparation for clinical studies. Review and approve vendor invoices for payment and codes invoices. Provide a variance analysis of budget to actual and notifies finance of projected cost overruns/underruns. Ability to travel (no more than annual average of 20%).  Requirements Bachelor's Degree is required. RN, or MS, advance degree in scientific discipline, business/finance courses is preferred. 3+ years of experience gained with a CRO or Pharmaceutical Company working on Phase I - IV clinical studies of innovative medicines. 3+ years clinical project management experience with clinical studies. Experience in managing multinational studies. Strong organization skills and ability to deal with competing priorities, also strong reasoning and problem solving ability. Excellent communication skills: written and verbal. Leadership skills Knowledge of clinical trial management. Apply project management best practices to programs. Experience in novel clinical drug development. Experience with infectious diseases or oncology a plus. Experience running early development (Phase I/Phase II) and Phase III clinical programs plus solid knowledge of all aspects of clinical trials and knowledge of clinical trial management. Solid experience in the managing of CROs and vendors. Budgeting, timeline/resource management, and contract negotiation experience. Protocol, CRF, CSR design and review. Extremely strong organization skill and ability to deal with competing priorities. Knowledge of GCP/GMP/GLP regulations. Good computer skills and presentation skills. Proficient with MS Office Suite (Excel, Word and PowerPoint) familiar with MS Project.      MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: Cambridge, MA 02138 JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Temporary/Contract/Project JOB REFCODE: APcontractMA910kd COMPANY: MRINetwork EMAIL: Apply by Email