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Job #03117

About our client Our client is a drug development company that creates new therapeutics by considerably improving the pharmacokinetic (PK) and pharmacodynamic (PD) properties of approved drugs and late stage compounds. Position Location Project Manager – Clinical Brigton, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop clinical protocols and informed consent documents 2) Review CRFs and CRF guidelines as well as edit data and check specifications 3) Develop and implement study-specific monitoring plan, study tools and a communication plan, study budget, timelines and tracking systems 4) Ensure studies are conducted as per ICH/GCP guidelines 5) Develop and review outsourcing specification for RFPs for clinical research contractors 6) Manage site, vendor management and clinical documentation 7) Oversee day-to-day activities of the clinical trial and associated resources (CRO, central labs and other clinical research contractors) 8) Communicate regularly with vendors 9) Ensure timely start up/completion of clinical studies and deliverables (monitoring plan, data management plans, etc.) 10) Conduct on-site monitoring including initiation visits, routine co-monitoring and close out visits as well as site management 11) Assist in study audits 12) Oversee and manage CROs, central labs and other clinical research contractors 13) Identify data deficiencies and discrepancies as well as coordinate corrective action 14) Oversee Serious Adverse Event reporting including documentation, tracking and follow-up 15) Assess study drug requirements and shipment logistics with VP of Chemical Development 16) Review proposals to ensure accurate summary of protocol requirements 17) Work with Regulatory Affairs to ensure compliance 18) Provide input to clinical protocol documentation for suggested edits, case report forms, data management plans, clinical study reports and regulatory filings Requirements 1) RN, BS or MS in a Healthcare or Life Sciences discipline 2) Minimum 5 years of experience in the CRO, biotech, pharmaceutical industry 3) Experience in cardiovascular/metabolic diseases 4) Minimum 3 – 5 years of hands-on clinical operations experience (specific experience in Phase II trials as well as all clinical phases) 5) Experience in clinical budget planning, management and reconciliation 6) Superb site management and monitoring experience 7) Proficiency in MS Office (Excel, PowerPoint and Word) 8) Strong knowledge of ICH/GCP guidelines 9) Good understanding of clinical and regulatory functions such as data management, medical writing and bio-statistics 10) Effective time-management skills with ability to multi-task 11) Good interpersonal and communication skills 12) Strong leadership skills 13) Flexible with ability to perform hands-on activities in addition to involvement in strategy 14) Ability to foster effective relationships with vendors, investigators and colleagues 15) Ability to contribute technical expertise to the various aspects of the clinical trial process 16) Ability to work in a small company environment 17) Willingness to travel (up to 25%)