Senior Clinical Trial Manager - US or Canada - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Senior Clinical Trials Manager (Sr. CTM) will be a member of the client’s Clinical Operations team. Key Accountabilities:   Oversight of activities  Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team.  Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials  Provide direction and leadership in CRO and vendor selection and management.  Knowledge of regulatory start up process and planning in support of study start up  Managing and maintaining high performing clinical teams  Coordination of global clinical trials  Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.  Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.  Be responsible for and manage clinical research activity of Clinical Operations team  Estimate, track and critically analyze vendor financial spend on study   Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs  Provide guidance, direction, and management to site monitoring activity  Coordinate patient enrollment activities and mitigation planning  Coordinate study supplies with regulatory and clinical supplies functions  Negotiate contracts with vendors of clinical trial services  Review Informed Consent Forms, CRFs, and study related materials  Plan and participate in investigator meetings  Assist and support data query process  Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines  Ensures trial master file is current and maintained Collaborative relationships  Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials. Collaborate in the development of programming specifications. Skills:  Excellent oral and written communication skills and strong organizational abilities  Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)  Demonstrated ability to work independently and in a team environment  Ability to prioritize and manage multiple tasks simultaneously.  Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.    Knowledge and Experience:   Proven experience of clinical trial management  Proven management of people in a matrixed environment  Experience in CNS and / or oncology is preferred  Management of global clinical trials  Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations  Travel required. Must be willing to travel 15-25%, including international travel.  Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)     Education:   BA/BS, nursing degree, or advanced degree.  Degree in the life sciences preferred  #LI-LO1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40 years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™