Clinical Trial Manager

Company: Tasly Pharmaceuticals Inc.
Location: Rockville
Posted on: May 29, 2023

Job Description:

Clinical Trial Manager (CTM) Location: Rockville, MD or Homebased Type: Full-time contractor/ employeeSalary: 120K AnnualOverviewThe clinical trial manager is a member of a matrix team dedicated to the implementation of clinical research studies and development of programs and clinical trials. CTM is responsible for assisting clinical project manager managing all assigned clinical projects, site management, CRA management, and also supporting regulatory affairs, data management, medical writing, biostatistics, medical affairs to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines, Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.Preferred Therapeutic Areas Experience:Cardiac DiseaseCNSOncologyDuties and Responsibilities:Demonstrating outstanding scientific knowledge applicable to clinical research and the highest personal and ethical standardsResponsible/Assisting for preparation of clinical operation documents and study plans (PMP, CMP etc)Responsible and capable of preparing/revising/finalizing study essential documents, regulatory binders independently.Lead site contract and budget negotiations and implementationOversee clinical sites overall performance to ensure meeting recruitment goals and deliver high quality data on time.Assisting CPM track project performance, site level progress to ensure all projects are delivered on-time, within scope and budgetAssisting CPM manage all assigned clinical trials from start up phase through close out activitiesAssisting CPM with site identification, feasibility, and selection processDevelop clinical Standard Operating Procedures (SOPs)Provide direct supervision of CRAs and attend on-site monitoring with CRAs as neededReview monitoring trip reports completed by CRAsAssisting CPM plan and participate in Investigator Meeting/Client meeting/Bid defense meetingProvide clinical related training for R&D team members and/or other department membersContinually developing knowledge and skill to strengthen job performanceMaintaining the highest standard in complying with the company regulations and behavior standards. Engage in open and honest communicationHandling sensitive and confidential information with tact, discretion and judgmentPerforming other related duties as required and assignedRequirements:Bachelor's degree in life sciences, or other relevant discipline required, advanced degree preferred.Minimum of 5-6 years' clinical research experience as clinical trial manager in the CRO company is required.Direct site management experience is requiredOn-site clinical monitoring experience as CRA in the past is preferredSolid understanding of FDA and other regulatory requirementsThorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial managementStrong interpersonal and communication skillsProficiency with MS Office suite (word, excel, PowerPoint, and outlook) Working knowledge of MS Project for development and update of clinical study timelinesBenefits:Annual Vacation - Depending on the employment tenure and hired date, employees can earn up to twenty-five (25) days of accrued annual vacation. Employees may carry over up to four hundred and eighty (480) accrued vacation hours into the next year (starting January 1st) in addition to seven (7) sick days, eight (8) observed federal holidays, and three (3) floating holidays. Health Insurance - Health insurance is provided after thirty (30) days from the date of hire. Medical, dental, and vision coverage is provided by CareFirst Blue Cross Blue Shield (BCBS), dental by CareFirst BCBS, and vision by VSP.Long Term Disability - A monthly benefit of 60% of an employee's monthly earnings to a maximum monthly benefit of $6,000, is provided after 30 days from the date of hire. 401(k) Plan - Employees have the option to participate in a 401(k) Plan after a six-month waiting period. The company matches 5% of total salary.Short-Term Disability - Employees have the option to participate in short term disability (voluntary) or other insurance with Aflac.Additional Tasly U.S. benefits:Business Travel Protection Employee Assistance Program (EAP) Employee Retail Discounted Program Workers CompensationWilling to travel up to 20%-30% if required.Tasly Pharmaceuticals, Inc. is an Equal Opportunity EmployerPDN-992f4c02-0b89-4577-9133-15bfb70f0b03

Keywords: Tasly Pharmaceuticals Inc., Rockville , Clinical Trial Manager, Executive , Rockville, Maryland