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    Senior Clinical Trial Associate - Watertown, United States - Scipher Medicine

    Scipher Medicine
    Scipher Medicine Watertown, United States

    3 days ago

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    Description

    At Scipher Medicine, we are revolutionizing the way medical treatments are prescribed. Leveraging our innovative platform, we ensure patients receive the treatment that matches their unique biological makeup. Our goal is to optimize treatment from day one and drive novel target discovery to cater to patients who remain unresponsive to existing therapies. To achieve this, we are looking for a data scientist skilled in data pipeline development, database management, and cloud computing to join our team.

    The Role

    The Senior Clinical Trial Associate candidate will be responsible for supporting clinical studies while effectively organizing and assisting in the start-up, implementation, management and close-out of our clinical trials.

    What will I do?

    Provide overall program support to the Clinical Operations team as well as liaise with other internal and external collaborators

    Assist with the drafting or review of study specific documents and plans such as informed consent forms, site training manuals, regulatory documents etc.

    Ensure study contact lists, metric trackers, checklists, and systems are up to date

    Assist with the development of the electronic case report form by providing review/input with clinical research, protocol, and site perspectives

    Participate in monitoring visits, as needed

    Plans site and CRA trainings

    Acts as a liaison and resource for clinical trial sites

    Track clinical data entry expectations against monitoring activities and performance in preparation for data review meetings, data cuts, regulatory submissions, etc.

    Collaborate with vendors and CROs

    Manage the TMF by overseeing document collection and filing, ensuring compliance with the TMF plan, and performing periodic QCs

    Communicate with CROs and study sites to drive successful trial completion

    Assists in the development of timelines; tracks performance to forecasts

    Play a key role in the review of study specific data review

    Plan study related meetings and draft meeting agendas and minutes

    Effectively communicate trial details to ensure that all team members are kept informed

    Properly elevate particular situations with understanding of action items and their impact on the present & future

    Participate in the development and review of SOPs

    Minimum Education and Qualifications

    Bachelors degree in a relevant field

    5 plus years experience within a Clinical Operations team

    Prior experience managing sites and being directly responsible for their performance at the Sponsor level

    Experience in diagnostic development trials a plus

    Solid knowledge of Good Clinical Practice (GCP) and the Code of Federal Regulations (CFR) is required

    Broad knowledge in clinical monitoring activities, site management and essential site documents

    Ability to work within a matrix team environment

    Strong communication skills, both written and verbal

    Ability to laugh at yourself

    75% travel required

    Scipher is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law

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