Senior Clinical Trial Manager - FSP

My research opens up new medical possibilities. And I do it Search Jobs Search Jobs Keyword Matching job links will appear below as you type. Location: When autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures. Radius: Enter distance 5 15 25 35 50 Unit MILES KM View Remote Jobs View All Jobs View remote jobs View all jobs Senior Clinical Trial Manager - FSP Primary Location: United States, Remote Job ID R0000046284 Category Clinical Trials Apply Now About This Role Job Summary: The Senior Clinical Trial Manager is accountable for the end-to-end clinical trial delivery, providing operational leadership and oversight of cross-functional deliverables and leading a cross functional trial team to build and deliver the trial operational plan. This role is responsible for identifying and mitigating risks to effectively deliver assigned trials on time, within budget, and in a compliant manner. Key Responsibilities Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution.Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL/ CSR/ TLR planning and scope, define protocol deviations and resolution pathways).Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goalsIdentify risks and ensure mitigations and contingencies are being initiated and followed throughEnsure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processesParticipate in preparation for, and conduct of, Health Authority Inspections and internal QA auditsEnsure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversightParticipate in process improvement activities at a trial and department level as neededMentor & support onboarding of new team members, particularly those in Study Management.Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.Support and provide input into internal governance presentations & updatesAbility to travel approximately 10% but flexibility to go over or below as per business need. Qualifications BS/ BA degree is required.Minimum 7+ years of clinical research experience gained directly with a CRO, Biotech or Pharmaceutical Company leading on Phase 1-4 global clinical trials end to end. 3-5 years direct experience leading end to end global clinical trialsExperience overseeing/leading global trials outsourced to a CRO vendor and ability to manage all aspects of execution of a clinical trialExcellent decision-making, analytical and financial management skills are essential to this positionExcellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervisionExperience in leading without authority and in multifunctional matrixed and global environmentsExperience mentoring/ coaching othersExceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.Strong project planning/ management, communication (written and verbal) and presentation skillsProficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Apply Now Share this Page XFacebookLinkedInEmailMeet Hina, an Executive Director championing excellence and empathy Parexel's Hina Saleem, Executive Director, Clinical Operations, shares how empathy and excellence drive her approach to clinical trial optimization and authentic leadership. Learn more Meet Margaret: Clinical Research Nurse Find out why Margaret enjoys working as a Nurse in Clinical Research and working at Parexel, also how Parexel supports her in a way she hasn't experienced anywhere else. 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Learn more JOBS FOR YOU Senior Clinical Trial Manager - FSP United States of America, RemoteRegulatory Affairs Consultant - CMC Biologics / Plasma Products United States of America, RemoteClinical Trial Manager - FSP United States of America, Remote View All Jobs There is no jobs to view You currently have no saved jobs to view. Make sure to accept the Functional cookies to enable this module to display saved job links. You will be able to review them here when you revisit this page.. View Open Positions More Than A Job Benefits Benefits vary by country, but Parexel is passionate about our team’s overall wellness. Learn More Career Advancement We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career. Learn More