Jobs
>
Cambridge

    Director, Clinical Data Management - Cambridge, United States - BioSpace

    BioSpace
    BioSpace Cambridge, United States

    2 weeks ago

    BioSpace background
    Description
    Job Details

    About the role

    Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director Clinical Data Management, this individual will report to the Senior Director Clinical Data Management to be responsible for effective leadership, strategic planning, and oversight at the portfolio level within the Global Clinical Data Management function. This position requires working with key stakeholders and leading clinical data management activities to support regulatory submissions, inspections, and audits. You will be responsible for overseeing clinical data management teams to execute activities to ensure high quality data. You will lead strategy development for the assigned area and development and implementation of clinical data management policies, SOPs, processes, clinical systems, documents, and other tools.

    What you'll do
    • Serve as data management lead for multiple products or indications of considerable complexity
    • Provide input on vendor and technology evaluation, selection, and performance
    • Lead CDM strategies for the assigned area
    • Oversee and direct the design and implementation of the CDM process with vendors, including clinical systems design, build and testing, data integration, data review, dictionary coding, data quality checking, data transfer, reporting, and archival activities for EDC, IRT, and other clinical systems
    • Review and author technical documents including reports, process descriptions, SOPs, data management plans, data transfer agreements, reconciliation plans, and related documents at the study and department levels
    • Provide technical and business process expertise on new and emerging technologies / vendors for clinical trial execution
    • Lead and manage a team of direct reports and may manage other people leaders
    • Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
    • Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
    • Drive curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced performance driven environment
    • Innate ability to assess talent that will help grow the organization and add to Sana's culture
    What we're looking for
    • Progressive experience in clinical data management in the pharmaceutical, biotechnology, or CRO industry of at least 10 years
    • Extensive background collaborating with CROs, vendors, and internal study teams
    • In-depth knowledge and experience with different clinical systems such as electronic data capture (EDC) systems, IRT and other data collection systems
    • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Sana SOPs and ensures the same across own team
    • Broad knowledge and clear understanding of Food and Drug Administration (FDA) requirements related to electronic systems and records; strong understanding of guidelines as they relate to CDM, including Good Clinical Practice (GCP) and International Council on Harmonisation for Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines
    What will separate you from the crowd
    • Highly competent in clinical data management and use of technology for data capture including data visualization tools
    What you should know
    • The base pay range for this position at commencement of employment is expected to be between $200,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
    How we work together for patients
    • Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
    • Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
    • Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution
    Get to know us

    At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

    Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal .

    We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

    To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
  • NR Consulting LLC

    Data Management Specialist

    1 week ago

    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 · - ...

  • The Charles Stark Draper Laboratory Inc

    Data Management Analyst

    1 week ago

    The Charles Stark Draper Laboratory Inc Cambridge, United States

    Overview: · **Equal Employment Opportunity** · Draper is committed to creating a diverse environment and is proud to be an affirmative action and equal opportunity employer. We understand the value of diversity and its impact on a high-performance culture. All qualified applicant ...

  • NR Consulting LLC

    Data Management Coordinator

    2 weeks ago

    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 ...

  • Outcomes Operating Inc

    Manager, Data Services

    1 week ago

    Outcomes Operating Inc Boston, United States

    **JOB SUMMARY** · As a manager, your focus will be technical leadership and helping to shape the success of the development team. You will direct the team to provide an effortless experience for our clients by coordinating with development leadership, hosting team meetings, maint ...

  • Katalyst Healthcares & Life Sciences

    Clinical Data Manager

    1 week ago

    Katalyst Healthcares & Life Sciences Boston, United States

    **Responsibilities**: · - Lead the design of data collection and management systems and initiate process improvements as needed. · - Establish goals, timelines, and deliverables for data management of Client's trials, and oversee priorities and timelines for all data staff to pro ...

  • Pine Street Inn

    Outreach Data and Administration Manager

    1 week ago

    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 ...

  • Grand Circle LLC

    Data Warehouse Project Manager

    3 weeks ago

    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 ...

  • Harvard University

    Academic Operations and Salesforce Data Management

    2 weeks ago

    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 ...

  • Ipsen Bioscience, Inc.

    Clinical Data Management Study Lead

    1 week ago

    Ipsen Bioscience, Inc. Cambridge, United States

    **Clinical Data Management Study Lead**: · **Summary/Purpose of the Position**: · **The Clinical Data Management (CDM) Study Lead defines, implements, and monitors the Data Management strategy for one or more clinical studies in Ipsen portfolio. The Study Lead is responsible for ...

  • Boston University

    Data Manager, School of Medicine, Slone

    1 week ago

    Boston University Boston, United States

    The Slone Epidemiology Center, a multi-disciplinary research group at BUMC, is seeking a Data Manager to join a collaborative team of researchers. The Data Manager will have the opportunity to participate in exciting research for the Black Womens Health Study, working with a tigh ...

  • Mass General Brigham

    Clinical Data Manager, Mgh Oos

    2 weeks ago

    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

    Data Center and Active Directory Manager

    3 weeks ago

    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 ...

  • Boston Dynamics

    Data Operations Manager

    1 week ago

    Boston Dynamics Waltham, United States

    As a Data Operations Manager on a new product team at Boston Dynamics, you'll play a critical role in establishing robust data assets which power AI-driven robotics. You'll build and run efficient, robust processes for machine learning annotation, robot teleoperation, and synthet ...

  • SRG Talent

    Manager, Data Management

    4 weeks ago

    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

    manager data management

    2 weeks ago

    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 ...

  • Gordon's Fine Wines & Liquors

    ERP Data Management Analyst

    1 week ago

    Gordon's Fine Wines & Liquors Needham Heights, United States

    Gordon's Fine Wine is a prestigious fourth-generation leader in fine wines, spirits, and craft beer across New England. Following our recent expansion with the acquisition of Bakers' Best Catering, we aim to redefine the gourmet experience by blending renowned retail offerings wi ...

  • Prometrika LLC

    manager data management

    1 week ago

    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

    3 weeks 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

    3 weeks 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 ...

  • University Instructors

    Data Manager

    2 days ago

    University Instructors Boston, United States

    Overview · University Instructors (UI) is seeking a dynamic Manager of Data Services (MDS) to manage the data services team under the direction of the UI Executive Vice President. The MDS will oversee data governance which includes setting quality assurance measures to successfu ...