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    Senior Clinical Trials Manager - Waltham, United States - Clinical Dynamix

    Clinical Dynamix
    Clinical Dynamix Waltham, United States

    Found in: Lensa US 4 C2 - 5 days ago

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    Description
    Global Publicly Traded Pharmaceutical company is expanding.

    The Senior Clinical Trials Manager / Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget.

    Senior CTM / CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.

    Candidates should be located in MA as office is in Waltham and will require on-site presence from time to time.

    Responsibilities Accountable for project related efforts for the delivery of studies or programs that are critical to a product's clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.

    Supports external vendor selection and management process and assists in the development of RFP's and vendor oversight plans.
    Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
    Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines. Project leadership of the cross-functional study team, including external team members, CROs and vendors.
    Plan, negotiate, and manage site budgets as well as facilitate site contracting process. Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones. May provide technical advice to team members. Disseminate clinical program communications to all functional groups and leads program, study and team meetings. Interact with clinical research investigators, Key Opinion Leaders and sites. Interact with Senior Management to report on progress of milestones.

    Oversight of study team and site training Facilitation of Quality processes and Quality Assurance interactions for assigned project(s) Management of study drug distribution and accountability processes and documentation Oversight of study start-up, study management, data cleaning, and study closeout activities Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.

    RequirementsBA/BS degree in Health or Life Sciences required, advanced degree preferred A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role Exceptional communication and interpersonal skillsPositive team orientated attitude Must speak fluent English if it is their second languageAdvanced proficiency in Microsoft Office and Microsoft Project Reliable, self-motivated, team player Detail oriented with excellent organizational skills Ability to effectively manage multiple tasks and competing prioritiesCreative problem solver Ability to travel is required Company offers a flexible work environment.

    This position is a hybrid work model based out of our Waltham, MA office.

    Company offers a comprehensive benefits package including:

    • Remote work with technology tools and infrastructure
    • Competitive pay and stock options for all employees
    • Medical, dental, and vision coverage with 100% of premiums paid by Company for employees and their eligible dependents
    • Company paid insurance programs
    • Short- and long-term disability coverage
    • Life, Travel and AD&D
    • 401(k) Company Match with immediate company vest
    • Employee Stock Purchase plan
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