Sage Therapeutics

  • Clinical Study Manager, Consultant (Contract) / Clinical Operations Consultant

    Job Locations US-MA-Cambridge
    Posted Date 2 weeks ago(7/3/2018 2:30 PM)
    ID
    2018-2239
    # of Openings
    1
    Category
    Clinical
  • Overview

    Clinical Study Manager, Consultant - Clinical Operations & Development

    General Scope and Summary

     

    Oversee clinical trials (pre-IND through Phase 1-3 clinical trials) in the field of neurology and CNS disorders contributing to the clinical development program. This key role will manage, plan, and execute clinical studies, including creating and managing study timelines, budgets, and study management plans in a full out-sourced model with initial focus on Clinical Pharmacology Program studies. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s).  This position will report to the Associate Director of Clinical Operations.

     

    Roles and Responsibilities

    • Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
    • Create, manage, and execute clinical operations programs, including ClinPharm study management, and budget and Gantt timeline creation
    • Lead cross-functional ClinPharm study management teams(s) with effective communication of study progress, risk mitigation and budget management aligned with study and Program goals
    • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
    • Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
    • Co-monitor or monitor studies if needed for the program Oversee the management of the electronic Trial Master File (TMF), holding team ensuring quality and completeness
    • Develop and ensure execution of activities outlined in various study plans (vendor management, data management, safety management, site monitoring, TMF management, and study communication plans)
    • Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed
    • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies and manuals for clinical trials
    • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
    • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
    • Minimal travel (10-20%) as needed to oversee and support study execution 

    Experience, Education and Specialized Knowledge and Skills

     

    • Master’s degree preferred in a scientific or healthcare discipline
    • Minimum of 6-8 years in clinical and drug development in the pharmaceutical/biotech industry, at least 3 years of direct study management work preferred
    • Understanding of drug development from pre-IND through NDA
    • Extensive experience managing clinical programs, CROs, budgets, and timelines required
    • Strong working knowledge of MS Project and developing Gantt charts
    • Excellent oral, written, and medical communication skills required
    • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
    • Management of CROs, multiple vendors, and complex protocols
    • Protocol, ICF, and CSR writing experience required
    • A detailed understanding of overall strategic direction, interrelationships and business needs
    • Experience is CNS/Neurology preferred and experience managing Clinical Pharmacology studies will be favorably considered
    • Proven experience in the oversight of the operational aspects of all stages of clinical studies
    • Ability to organize and manage multiple priorities required

    Attributes

    • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
    • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
    • Proactive and positive management approach
    • Maximum flexibility to adapt to changing program needs in real time
    • Strong leadership skills and self-awareness
    • Ability to build strong relationships with co-workers of various backgrounds and expertise
    • Excitement about the vision and mission of Sage

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