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Job #02799

About our client Our client is a global biopharmaceutical company headquartered in MA that is dedicated to the development and commercialization of therapeutics for the treatment of anti infective diseases. The company has marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! Position Location Senior Clinical Trials Manager Lexington, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the development of clinical trials, including the development of the overall clinical plan, protocols, informed consent documents, Case Report Forms (CRFs), CRF guidelines, statistical and pharmacokinetic analysis plans 2) Coordinate the request for proposal process, including negotiation of budget, defining expectations and deliverables along with assessing qualifications, experience and participating in final selection 3) Oversee data management plans, including edit check specifications 4) Lead the identification of overall resourcing needs for assigned projects, including internal and external outsourced services (i.e. CROs, central laboratories, contractors, in-house CRAs, etc.) 5) Oversee the development and implementation of study-specific monitoring plan, study tools, including communication plan, investigator grants, study budget, study timelines as well as subject and study tracking systems 6) Advise and train CRO personnel on project-related educational needs 7) Define site qualification criteria and oversee the identification of potential investigators and clinical sites 8) Oversee and participate (as needed) in pre-study site visits 9) Review evaluative reports 10) Participate in the final selection of study sites 11) Oversee the day-to-day activities of the clinical trial and associated resources (CROs, CRAs, centralized laboratories, etc.) 12) Assess study drug requirements and shipment logistics 13) Oversee and participate (as needed) in initiation visits, review of reports and follow-up to identify and resolve site issues 14) Define site approval process with respect to critical document requirements, Institutional Review Board (IRB) approvals, IRB questions, site informed consent review and review of contracts, in conjunction with relevant internal departments (as necessary) 15) Oversee and participate in investigator meetings 16) Identify and evaluate issues related to the project and coordinate resolutions 17) Oversee and participate (as needed) in site monitoring visits 18) Ensure appropriate transmission of CRF data to the Data Management Team and review queries 19) Identify data deficiency and discrepancies, and coordinate corrective action (as required) 20) Oversee Serious Adverse Event reporting, including documentation, tracking and follow-up 21) Assist in site audit process and coordinate audit responses to ensure conformance to industry and company standards 22) Study closeout activities and Clinical Study Report (CSR) writing process 23) Oversee and participate (as needed) in site close-out visits, review of reports and follow-up to identify and resolve final site issues 24) Coordinate the interaction between relevant parties in the database lock process 25) Define and coordinate the review and approval process of tables, listings and graphs 26) Coordinate CSR writing, review and approval process, including the compilation of all required sections Requirements 1) BS/BA/BSN – health-related field preferred 2) Minimum 2 years of relevant industry experience 3) Demonstrated ability to work independently as well as in a team environment and seek resources (as necessary) 4) Ability to identify the need for and take the lead role developing and reviewing of Standard Operating Procedures and other interdepartmental standards 5) Ability to assess complex issues and propose viable solutions 6) Demonstrated ability to lead and organize team meetings 7) Ability to foster effective relationships with vendors, investigators and colleagues 8) Ability to contribute technical expertise to the various aspects of the clinical trial process 9) Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR 10) Proficiency in study monitoring activities 11) Knowledge of the infrastructure and operational characteristics of CROs and centralized services 12) Demonstrated effective time-management skills 13) Excellent communication, writing and presentation skills