Jobs
>
Cambridge

    Associate Director/Director, Data Management - Cambridge, United States - PepGen

    Default job background
    Full time
    Description

    Associate Director/Director, Data Management

    Position Summary
    The Associate Director/Director of Data Management (DM) will act as the DM lead of several programs with accountability for all DM activities including study set-up, review, cleaning, and delivery of clinical data. This role is responsible for timely and high-quality data management deliverables supporting the clinical development, regulatory submissions, and inspections at PepGen.
    Responsibilities

    • Oversees and directs clinical data management (CDM) activities across multiple studies and compounds.
    • Participates in the development/review of all CDM end-to-end activities including eCRFs, CRF Completion Guidelines, Data Management Plans, Edit Checks, Data Review Plans, Data Transfer Specifications, maintenance of clinical study database, as well as oversight of data finalization and database lock activities, etc.
    • Helps manage the performance of CROs and other third party vendors.
    • Participates to best practices initiatives, identify the need, and participate to the creation of functional standard operating procedures (SOPs), Work Instructions, job aids, and other training documents.
    • Leads data cleaning activities such as study team data reviews, SAE reconciliation, non-CRF data reconciliation, non-system edit checks.
    • Provides direction and guidance to team members, including consultants and vendors to achieve/meet corporate goals and milestones.
    • Oversees the tracking of important study metrics on data entry, source data verification, query status, data trends and presents these metrics to a cross-functional team as required.
    • Proactively identifies risks and executes risk mitigation strategies; Maintains timely communication with management and cross-functional teams.


    Requirements

    • Master's Degree preferred or bachelor's degree with extensive years of DM work experience in the pharmaceutical or biotechnology industry required.
    • Thorough knowledge/understanding of the principles of clinical research, ICH, GCP, GCDMP, CDASH/SDTM, and other regulatory standards.
    • Demonstrated project management experience with ability to perform under tight timelines while balancing conflicting priorities.
    • Experience working with and managing external service providers/vendors.
    • Cross collaboration proficiency with other functional areas with ability to work effectively in a team setting, as well as independently.
    • Strong organizational, time management, and resource-allocation skills with the ability to perform and prioritize multiple tasks and projects seamlessly with excellent attention to detail.
    • Flexible with excellent problem-solving and negotiation skills.
    • Relevant therapeutic experience in rare diseases desired.


    About PepGen
    PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen's Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit or follow PepGen on Twitter and LinkedIn.
    EEO Statement
    PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
    Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.
    Recruitment & Staffing Agencies
    PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.



  • NR Consulting LLC Boston, United States

    Job Summary: · **Responsibilities**: · - Develop and implement databases, data collection systems, data analytics, and other strategies that optimize statistical efficiency and quality · - Acquire data from primary or secondary data sources and maintain databases/data systems · - ...


  • NR Consulting LLC Boston, United States

    The Women's Veterans' Network **DATA** Coordinator works under the guidance of the Executive Office of Veterans' Services WVN Director. The Women Veterans' Network **DATA** Coordinator collects, coordinates, and **executes and maintains the women veteran centric database.** · Rec ...


  • Grand Circle LLC Boston, United States

    **Title**:Data Warehouse Project Manager · **Location**:Boston, MA (hybrid) · **Rate**:DOE · **Data Warehouse Project Manager** · Grand Circle is seeking an exceptionally talented and motivated individual to join our Data Engineering team. This position presents the opportunity t ...


  • Pine Street Inn Boston, United States

    **SCHEDULE**:40 hours, Monday-Friday, 8:00 a.m. - 4:30 p.m., evenings and weekends as needed · **Pays $31.91 per hour** · **LOCATION**:Office located at 105 Chauncey Street · **JOB DESCRIPTION**: · **SUMMARY OF POSITION**: · The Outreach Data and Administration Manager oversees P ...


  • Harvard University Cambridge, United States

    **Job Summary** · **Position Description** · The Specialist provides ongoing support to faculty, teaching assistants (TA), and internal stakeholders, identifying opportunities for technology enhancements that improve academic operations and classroom performance. This position tr ...


  • Mass General Brigham Boston, United States

    **Clinical Data Manager, MGH OOS** · GENERAL SUMMARY/ OVERVIEW STATEMENT: · Receiving direction from the Director of Data Management of the Neurological Clinical Research Institute (NCRI), the incumbent will use a clinical trial data management system for data collection, analysi ...


  • Town of Brookline Brookline, United States

    The Town of Brookline Information Technology Department is seeking a hands-on Data Center and Active Directory Manager to perform professional technical work in connection with all areas of data center, servers, operating systems, storage and active directory administration, incl ...


  • SRG Talent Cambridge, United States

    Job Title: Manager, Clinical Data ManagementLocation: Cambridge, MaWorksite: On-site M-F, Potential HybridJob Type: Full-Time permanentWe are searching for a full-time Manager of Clinical Data Management for a Global Pharmaceutical CRO located in Cambridge, Mass. This role is res ...


  • Prometrika Cambridge, United States

    PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the peop ...


  • Prometrika LLC Cambridge, United States

    Job Description · Job DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our wor ...

  • The Ceres Group

    Data Manager

    1 week ago


    The Ceres Group Boston, MA, United States

    Reporting to the Chief Technology Officer, the Head of Data Management is responsible for the build out of the data management function, including a data strategy to enable insights to better service and manage our clients. Be a part of designing the future of the firms data tran ...

  • Avant-Garde Solutions, Ltd.

    Data Management

    1 week ago


    Avant-Garde Solutions, Ltd. Boston, MA, United States

    Our client is looking for a experienced Direcor to lead the Front Office Information Technology team. Candidate will possess a strong programming and quantitative background and will ne working directly with the trading teams and is responsible for developing, supporting, and mai ...


  • JACOBS DOUWE EGBERTS Maynard, United States

    Data Governance Manager · - Finance · - Maynard · - Full-time · - United States · - Collaborate with business stakeholders and system owners to gather requirements for new development projects related to opportunities for reporting solutions. · - Develop and maintain data flows i ...


  • ClinLab Staffing Cambridge, United States

    MANAGER DATA MANAGEMENT · Cambridge, MA, US · RESPONSIBILITIES · Manage and supervise a team of Clinical Data Managers (CDMs) · Oversee each project assigned to the team · QC each deliverable prior to sending to internal or external clients · Prepare and present individual ...


  • Apex Systems, Inc. Cambridge, MA, United States

    Compensation Manager Contractor · Support day-to-day compensation activities, including ad-hoc analysis, market data requests, and off-cycle pay adjustments/promotions. · Develop and create compensation tools, dashboards, and insights to support stakeholders in making data-driv ...


  • Nuvalent, Inc. Cambridge, United States

    The Company:With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a ...


  • Biogen Cambridge, MA, United States

    This role is responsible for clinical study bioanalytical and biomarker operations management. The bioanalytical and biomarkers study manger is a member of the clinical study team and will contribute to study start up, sample testing, data delivery and CRO management as it relate ...


  • Bayside Solutions Boston, United States

    Clinical Data Manager · Direct Hire Full-Time Role · Salary Range: $130,000 - $150,000 per year · Location: Boston, MA - Hybrid or Remote · Duties and Responsibilities: · You will develop and maintain study-specific documentation and manage clinical data. · Create Data Management ...


  • The Ceres Group Boston, MA, United States

    Reporting to the Chief Technology Officer, the Head of Data Management is responsible for the build out of the data management function, including a data strategy to enable insights to better service and manage our clients. Be a part of designing the future of the firms data tran ...


  • Sarepta Therapeutics Andover, United States

    The QC Data Manger will be responsible for overseeing review for accuracy and interpretation of data generated internally from testing laboratory charged with the execution of all GMP bioassay and Nucleic Acids Testing (release and stability) related to Sarepta's Gene Therapy pip ...