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Job #03195

About our client Our client is a molecular imaging company based in Northeastern USA. They focus on developing diagnostic agents to enable early diagnosis, treatment selection and therapeutic monitoring of serious chronic diseases. They have an outstanding management team with extensive imaging and CNS development experience, as well as a strong pipeline of candidates in clinical trials to detect Alzheimer's disease, Lewy body dementia, Parkinson’s disease and Diabetes mellitus. This is a unique opportunity to help build an organization from the ground up! Position Location Clinical Project Manager Philadelphia, Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee all aspects of the day-to-day conduct of one or more of the company’s clinical trials/programs 2) Provide guidance and expert advice leading to the development of all processes and SOPs for clinical trial conduct and GCP compliance 3) Assist in drafting and finalizing clinical trial protocols and Investigator’s brochures 4) Assist with preparation of INDs 5) Draft CRFs, template consent forms and source documents for site use 6) Participate in identifying and qualifying study sites 7) Prepare RFPs as well as participate in identifying, selecting and supervising CROs, central laboratories and core labs 8) Organize activities of project teams, external consultants, vendors and CROs 9) Participate directly in all study activities (as necessary) including site monitoring and/or supervision of contract CRAs performing site monitoring 10) Train and mentor subordinates including contract CRAs and junior internal staff to ensure project requirements are met as well as for staff growth and development 11) Assist with safety reports and oversee the completeness of CIOMS as well as follow-up data 12) Ensure the development, supervision and maintenance of trial master files and other relevant document storage 13) Assist with the daily, quarterly and annual periodic safety reports 14) Ensure development and assurance of timelines, milestones and budgets Requirements 1) Bachelor’s or higher degree in Life Sciences, Nursing or a related field 2) Minimum 3 years of clinical research experience, preferably in a pharmaceutical/radiopharmaceutical company or CRO 3) Hands-on experience in clinical trial monitoring and in-house activities 4) In-depth knowledge of GCP, ICH and US federal regulations (21CFR) 5) Superb communication skills (written and oral) 6) Ability to train and supervise junior staff