Jobs
>
Philadelphia

    Associate Director/Director, Clinical Data Management - Philadelphia, United States - Cabaletta Bio

    Cabaletta Bio
    Cabaletta Bio Philadelphia, United States

    1 week ago

    Default job background
    Description
    Associate Director/Director, Clinical Data Management (Remote)

    Philadelphia, PA

    About the Position


    The Associate Director, Clinical Data Management will manage all data management (DM) activities from start-up through long term follow up and archival, overseeing high quality databases for analysis and potential regulatory submissions.

    Responsibilities Include


    • Assist Data reconciliation of electronic data transfers from vendor to Sponsor.
    • Enthusiastic and knowledgeable communication with database (DB) vendors on consistent basis to address Clinical team requests and/or eCRF development activities.
    • Provide Clinical Data Management support to the Clinical team and other cross functional departments as needed.
    • Develop CRF, electronic and/or paper.
    • Participate in the review of Clinical research documents (e.g. Protocols, Case Report Forms).
    • Develop clinical trial data specifications, including CRF completion guidelines, user requirements, edit checks and rules, query logic and data validations.
    • Participate in UAT of eCRF build and validation documents, including but not limited to edit check document, issue log, and UAT summary report.
    • Assist with TLF Development for DSMB/IDMC and endpoint adjudication committees.
    • Participate in the preparation and presentation of data, when applicable.
    • Ensure data compliance by following the established guidelines of national and international regulatory authorities.
    • Assist in the review of routine/interim/final data listings prior to release to other groups or inclusion in regulatory submissions.
    • Assist in the gathering of EDC design requirements from stakeholders and to address the needs of sites (e.g., investigator, study coordinator, study monitor) .
    • Provide input and support on data and submission standards (e.g., SDTM,ADaM) to project teams to ensure high quality and timely deliverables that meet industry standards and regulatory requirements.
    • Support the identification, review, evaluation, and implementation of new technologies related to clinical data and to reduce site burden.
    • Participate in data standards process improvement working groups.
    Required Qualifications


    • Bachelor's degree in a science related field.
    • 8+ years data management and drug development in Clinical Data Management function.
    • 5+ years managing vendor relationships.
    • Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
    • BLA/NDA/CTD Experience preferred.
    • Experience of data management best practices, standards, library development and maintenance.
    • Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
    • Experience of broad drug development process with expertise in the interfaces with the data management function.
    • Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
    • Working knowledge of Clinical database applications such as EDC and CTMS.
    • Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
    • Ensure adherence to functional budget, and provide updates to manager regarding additional, potential spend or cost savings.
    • Knowledge of CDISC standards.
    • Experience performing CRF Design activities in a clinical research environment.
    • Outstanding verbal, written , organizational, interpersonal, and team skills.
    • Create and implement solutionsbased on direct experience.
    Apply For This Job
  • FIRE

    Data Manager

    1 week ago

    FIRE Philadelphia, United States

    This position will be based in Philadelphia, Pennsylvania or Washington, D.C. FIRE operates on a hybrid work schedule that allows for a mix of in-the-office and remote work for eligible employees. · **About FIRE**: · The Foundation for Individual Rights and Expression's mission i ...

  • Digitas Health

    Manager, Data and Analytics

    6 days ago

    Digitas Health Philadelphia, United States

    **Company Description** · Digitas Health is the Agency of Now: the first global connected-health agency, purpose-built for marketing today. Digitas Health specializes in helping health brands navigate a complex and shifting media environment to create deeper, more relevant connec ...

  • Federal Reserve Bank of Philadelphia

    Vp/svp Src Data Management and Analytics

    2 days ago

    Federal Reserve Bank of Philadelphia Philadelphia, United States

    Company · Federal Reserve Bank of Philadelphia · The Federal Reserve Bank of Philadelphia is one of the 12 regional Reserve Banks that, together with the Board of Governors in Washington, D.C., make up the Federal Reserve System. It helps formulate and implement monetary policy, ...

  • Fire Services

    Data Manager

    1 week ago

    Fire Services Philadelphia, United States

    This position will be based in Philadelphia, Pennsylvania or Washington, D.C. FIRE operates on a hybrid work schedule that allows for a mix of in-the-office and remote work for eligible employees. · About FIRE · The Foundation for Individual Rights and Expression's mission is to ...

  • Fire Services

    Data Manager

    3 days ago

    Fire Services Philadelphia, United States

    This position will be based in Philadelphia, Pennsylvania or Washington, D.C. FIRE operates on a hybrid work schedule that allows for a mix of in-the-office and remote work for eligible employees. · About FIRE · The Foundation for Individual Rights and Expression's mission is t ...

  • Macquarie

    Data Manager

    3 days ago

    Macquarie Philadelphia, United States

    Join Macquarie Asset Management as a Marketing Data Manager and be a part of a cross-functional Product Team that supports key business initiatives, leading on all aspects of data product management to help the Product Owner and Development team drive digitalization through well- ...

  • Macquarie Group

    Data Manager

    1 week ago

    Macquarie Group Philadelphia, PA, United States

    Join Macquarie Asset Management as a Marketing Data Manager and be a part of a cross-functional Product Team that supports key business initiatives, leading on all aspects of data product management to help the Product Owner and Development team drive digitalization through well- ...

  • FIRE

    Data Manager

    1 day ago

    FIRE Philadelphia, United States

    Job Description · Job DescriptionThis position will be based in Philadelphia, Pennsylvania or Washington, D.C. FIRE operates on a hybrid work schedule that allows for a mix of in-the-office and remote work for eligible employees. · About FIREThe Foundation for Individual Rights a ...

  • InsideHigherEd

    data manager

    15 hours ago

    InsideHigherEd Philadelphia, United States Administrative Jobs ,

    Duties: The Palliative and Advanced Illness Research (PAIR) Center is seeking a data manager to contribute to a variety of projects including studies of critical care outcomes, end-of-life decision making, and palliative care interventions. · This individual will be responsible ...

  • Organon

    Director, Data Management

    1 week ago

    Organon Plymouth Meeting, United States

    **The Position** · Reporting to Associate Vice President of Clinical Data Sciences (AVP CDS), the Director of Data Management will play a critical role in shaping and executing data management strategy and execution. The Director of Data Management will provide clinical data mana ...

  • Liberty Mutual

    Analyst, Data Management

    3 days ago

    Liberty Mutual Media, United States

    **Pay Philosophy** · The typical starting salary range for this role is determined by a number of factors including skills, experience, education, certifications and location. The full salary range for this role reflects the competitive labor market value for all employees in the ...

  • U.S. Bank National Association

    Data Analytics Manager

    15 hours ago

    U.S. Bank National Association Horsham, United States

    At U.S. Bank, we're on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and succeed. We believe it takes all of us to bring our shared ambition to life, and each ...

  • NiSource

    Data Governance Manager

    1 day ago

    NiSource Chester, United States

    **Description** · **Data Governance Manager - Platform Administration** · **Full Time** · **Way of Work**: Remote · **Salary**: $125,800 - $188,600, plus annual bonus · The Data Governance Department, under the Office of Innovation creates value by ensuring availability, usabilit ...

  • The Children's Hospital of Philadelphia

    Manager Data and Analytics

    3 days ago

    The Children's Hospital of Philadelphia Philadelphia, United States

    Reference #: SHIFT:Day (United States of America) · Seeking Breakthrough Makers · Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise ...

  • Digitas Health

    Manager Data and Analytics

    3 days ago

    Digitas Health Philadelphia, United States

    Job Description · We're searching for a Manager of Data & Analytics who can inspire teams to develop new paths for growth, while driving strategic thinking and economic insight across client engagements. You'll improve budget and programs through disciplined analysis for the best ...

  • Perpay Inc.

    Data Engineering Manager

    1 week ago

    Perpay Inc. Philadelphia, United States

    About Us: · We believe everyone deserves a chance to improve their financial future. We're dedicated to building simple and inclusive financial products that help our members create healthy habits and achieve economic stability. · Some things we're excited about: · $500 million i ...

  • Perpay - Career's Page

    Data Engineering Manager

    2 days ago

    Perpay - Career's Page Philadelphia, United States

    Job Description · Job DescriptionAbout Us:We believe everyone deserves a chance to improve their financial future. We're dedicated to building simple and inclusive financial products that help our members create healthy habits and achieve economic stability. · Some things we're e ...

  • American College of Radiology

    Clinical Data Manager

    1 week ago

    American College of Radiology Philadelphia, United States Full time

    Job Details · Description · The is a professional association serving over 42,000 members across the country. Consistent with the ACR's mission to advance the practice of radiology and improve the health outcomes of the populations we serve, the ACR's Center for Research and In ...

  • ZS

    Data Science Manager

    5 days ago

    ZS Philadelphia, United States Permanent

    ZS is a place where passion changes lives. As a management consulting and technology firm focused on transforming global healthcare and beyond, our most valuable asset is our people. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping solution ...

  • PVR Technologies

    Lead Clinical Data Manager

    1 week ago

    PVR Technologies King of Prussia, United States

    **DUTIES**: Draft, plan, review, and lead the cross-functional team in sponsor data review using J-Review and SAS listing; Perform query management with the cross-functional medical monitor on clinical operations, safety, and programming data review issues; Work with the team in ...