To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02975

About our client Our client is a global CRO that offers full-service clinical research capabilities across all therapeutic areas. Our client has successfully completed drug, biologic, device and diagnostics trials in an efficient and cost-effective manner for US, Japanese and European developers as well as CROs. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Project Manager Hillsburgh, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Contribute to creating and reviewing protocols, informed consents, CRFs, clinical study materials, monitoring tools and clinical study reports 2) Provide input for definition of new or revised process development, problem-solving, training, etc. (as needed) 3) Maintain frequent contact with and work effectively with investigators, coordinators and other site staff 4) Develop/manage clinical study budgets 5) Prepare and track required documentation from clinical sites 6) Conduct initiation, interim monitoring and closeout visits 7) Perform drug accountability (as needed) 8) Review and resolve discrepancies in clinical data with clinical sites 9) Maintain regular internal contact with relevant departments such as Data Management, Regulatory Affairs, QA, Pre-Clinical, Drug Safety and others (as necessary) 10) Guide and direct contract CRAs in the field 11) Ensure investigational sites’ regulatory compliance with company SOPs, FDA and ICH guidelines 12) Hire, train and lead Clinical Affairs staff 13) Create systems and procedures 14) Assign project distribution and manage workload 15) Provide technical leadership Requirements 1) BS in a scientific discipline or health-related field 2) 5+ years of clinical monitoring experience 3) Prior experience with dermatological/topical pharmaceuticals a plus 4) Experience in Phases I – III of drug development 5) Working knowledge of GCP, ICH guidelines and FDA regulations 6) Experience in getting clinical trials off the ground 7) Experience in managing trials from beginning to end 8) Self-starter on routine CRA work and ability to work with general instructions on new assignments 9) Ability to resolve routine issues independently 10) Excellent problem-solving skills in managing clinical sites 11) Tactful and diplomatic in dealing with study coordinators and physicians 12) Proficiency in computers 13) Excellent communication skills (oral and written) 14) Superb organizational abilities 15) Ability to work efficiently independently or in a team environment 16) Willingness to travel – up to 10% (domestic)