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Job #02221

About our client Our client is a leading global healthcare supplier and the world’s largest manufacturer of Over-the-Counter (OTC) pharmaceutical and nutritional products for the store-brand market. The company also develops, manufactures, and markets generic prescription (Rx) drugs, Active Pharmaceutical Ingredients (API), and consumer products. Position Location Project Manager New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee and manage study budgets for specified programs 2) Facilitate development and execution of clinical trial and confidentiality agreements 3) Review statistical analysis plans and data management plans 4) Organize and review clinical study reports 5) Support the development of clinical FDA submission strategies 6) Liaise with CRO and clinical sites to monitor study progress 7) Support the development of strategic clinical trial protocols (increased volume) 8) Implement project related decisions and facilitate new development systems 9) Liaise between internal departments and external partners 10) Organize and attend project team meetings and compile minutes 11) Generate internal and external correspondence and assist in the composition of study documents 12) Compile and review monthly progress reports 13) Ensure timely progression of project and compliance with rules and regulations 14) Organize and participate in Investigator meetings 15) Coordinate and facilitate meetings, document QC, teleconferences, clinical study needs, etc. 16) Organize start-up activities, support regulatory submissions, and maintain project files 17) Generate and manage pharmacovigilance plans/reports (SAE reporting) 18) Facilitate site selection and maintain site evaluations 19) Assess subject evaluability on an interim basis 20) Incorporate protocol specific requirement for labeling and packaging of study drugs 21) Assist in the compilation of monthly progress reports from CROs 22) Review incoming monitoring and enrollment reports 23) Protocol/amendment development 24) Review all applicable literature such as SBAs and FDA guidance, and other publications 25) Assess CRF design, modification/creation of ICF, Investigator brochures, study related forms/reports 26) Source documents in collaboration with the CRO, Data Management Group, and Biostatistician 27) Handle all project related budget and other financial issues and maintain records Requirements 1) Bachelor’s degree in a scientific discipline 2) 3-5 years hands-on experience in clinical research and project management 3) Minimum 2 years’ experience as a Clinical Research Associate 4) Ability to manage and prioritize multiple projects and take initiative 5) Hands-on experience in dermatology 6) In-depth knowledge of Federal and Clinical Guidance/Regulations 7) Certification and/or membership in professional associations (ACRP, DIA, SOCRA, etc.) 8) Good organizational and detail-orientation skills 9) Exhibit effective/professional written and verbal communication skills 10) Ability to work independently as well as a team 11) Knowledge of MS Office suite 12) Ability to travel – about 10%