Clinical Project Manager - Biopharma - Central New Jersey

This position is open as of 5/8/2008. Are you a fit? Click Here to Apply Now! Job Details Clinical Project Manager - Biopharma - Central New Jersey renderImage('http://www.cybercoders.com/images/search.png', 84, 39); Specifications Location   Princeton, NJ; New Brunswick, NJ Salary   $75,000 - $90,000 Education   Bachelor of Science Category   Pharmaceutical Experience Required   At least 2 Years Short Description   Clinical Project Manager - Biopharma - Central New Jersey Required Skills   Clinical Research, Project Management, Drug Development, CRO Management, GCP Regulations Recruiter   David Wright Date Updated   5/8/2008 Job Description Skills Required Clinical Research, Project Management, Drug Development, CRO Management, GCP Regulations Job Description Clinical Project Manager - Biopharma - Central New JerseyWe are a biopharmaceutical company focused on developing innovative, inhaled pharmaceuticals for the treatment of serious lung diseases. We are committed to significantly improving the quality of life and healthcare of patients suffering from these life-threatening diseases. Our operating principles are centered on teamwork, openness, mutual respect, diversity of opinion, trust, accountability and innovative science.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. * Provide overall cross-functional leadership to achieve project objectives on time, within budget and with high customer satisfaction. Manage integrations of all project team activities. * Execution of a clinical development program from protocol design to the final clinical study report for one or several studies. * Coordinate all efforts for the trial both within the company and through a wide variety of CRO and vendors. * Develop contingency/risk management plans for projects and assist Director of 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 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. * Manage contract research organizations * Manage study sites and tracking systems for 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. * Travel will be about 10 - 20%. Requirements * Bachelor's Degree is required. MS, advance degree in scientific discipline, business/finance courses is preferred. * 4+ years of experience gained with a CRO or Pharmaceutical Company working on Phase I - IV clinical studies. * 5+ 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 clinical drug development. * Experience with pulmonary, infectious disease projects 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. * Experience managing CROs a MUST. Budgeting, timeline/resource management, and contract negotiation experience. * Protocol and CRF review. You do not need to have written protocols. * 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. Must be authorized to work in the United States on a full-time basis for any employer. Location: Princeton, New Jersey; New Brunswick, New Jersey Want to interview today? Click Here to Do a Quick 2-Minute Online Interview! Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: Email your resume in Word to: David.Wright@CyberScientific.com **Please do NOT change the email subject line in any way. You must keep the JobID: CC MonsterAp : DW-NJ-CPM3 -- in the email subject line for your application to be considered.*** David Wright - Senior Recruiter - CyberScientific   logET();PauseFooter(false);