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

Job #02805

About our client Our client is a rapidly growing pharmaceutical company headquartered in Massachusetts that is focused on the development and commercialization of various pains therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Project Manager/Clinical Study Manager Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the overall operational activities involved in the planning, conduct and completion of clinical trials 2) Handle multiple tasks like protocol and CRF development, ordering clinical supplies, collection, review and filing of clinical trial documents, preparation of monitoring guidelines, critical thinking and analysis of study metrics, study variance tracking 3) Solve problems proactively in order to achieve work scope objectives, budgets and timelines within a project 4) Manage clinical research associates who conduct investigator identification, selection, training, and routine monitoring, maintaining and negotiating vendor contracts 5) Manage and execute trials through a combination of internal and external (CRO) staff and other duties as assigned or required 6) Communicate up-to-date information regarding trial progress to the Program Team and management 7) Serve as a primary contact with CRO to ensure appropriate communication 8) Identify potential investigators and clinical sites 9) Serve as primary contact with investigative sites to ensure that quality study deliverables are achieved 10) Manage site and vendor budgets and payments 11) Negotiate contracts with investigational sites and laboratories for content and pricing, ensuring that all regulations and legal requirements are met 12) Prepare and maintain patient recruitment and retention strategies 13) Lead the data review process 14) Maintain clinical study files and oversee the archival process 15) Participate in internal and external meetings 16) Ensure delegation of clinical project work to team members based on skills and abilities 17) Provide input to the performance appraisal process for Clinical Study Team members 18) Prepare and/or oversee IND serial submissions and annual reports 19) Contribute to clinical study reports, etc. 20) Develop and maintain effective working relationships with members of other groups involved in the clinical trial process, particularly Data Management, Regulatory, Safety, Pharmaceutics, and Clinical Monitoring groups within and outside the company 21) Ensure that all clinical aspects of studies are being carried out in accordance with GCP and ICH guidelines 22) Perform other activities (as assigned) Requirements 1) Bachelor’s degree preferably in Biology or Life Sciences (advanced degree preferred) 2) 3 – 6 years of clinical research or equivalent experience (preferably 2 – 4 of these years as Clinical Study Manager, Clinical Research Associate or a related relevant position) 3) Knowledge of FDA regulatory requirements and Good Clinical Practices 4) Experience in supporting regulatory submissions a plus 5) Ability and desire to work in a team-oriented environment 6) Excellent organizational skills 7) Proficiency in MS Word, Excel, Project and PowerPoint 8) Excellent written and verbal communication skills 9) Willingness and ability to travel (as needed) – up to 25%