Clinical Data Management Lead

3 weeks ago

Cambridge Massachusetts, United States AL Solutions Full time
Job Description

AL Solutions is seeking a highly experienced Senior Clinical Data Manager to join our team. As a key member of our clinical operations team, you will be responsible for overseeing and managing data management activities to ensure high-quality data collection tools, database design, and oversight of data management activities for our sponsored clinical trials.

Main Responsibilities:
  • Contribute to the selection and development of data collection tools for phase I-III studies, including EDC, eCOA, and eDiary tools.
  • Oversight and review of vendor data management activities, with accountability for study-level timeliness and quality of statistical deliveries.
  • Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Centralized Monitoring Plans).
  • Act as key contact for data management vendors to ensure effective communication between ourselves and the data management vendors.
  • Effective and close collaboration with the other members of the clinical team, including medical directors, clinical operations, biostatistics, and programming.
  • Provide internal data review to identify data issues using a range of data checks and visualizations.
  • Ensure essential documents are filed, allowing the reconstruction of each trial, are generated, filed, and maintained.
  • Maintain awareness of, and ensure compliance with, our policies and procedures relating to quality standards within the Company.
Requirements:
  • Bachelor's degree in a related field and 5 years of relevant experience required; at least 3 years of experience in clinical data management in a clinical research setting also required.
  • 2 years of experience in leading project teams required.
  • Certifications and/or courses completed in Medidata Rave Study Design and Build Essentials strongly preferred.
  • Overall understanding of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
  • Skilled in the use of computer technology, including clinical trial databases and applications (e.g., IBM Clinical Development, Medidata RaveX), and ability to learn new applications.
  • Detailed understanding of project planning and management methods.
  • Demonstrated ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes.
  • Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.
  • Ability to work in different projects with different priorities and act as team mentor and provide data management expertise.

  • Clinical Data Manager

    1 day ago

    Cambridge, Massachusetts, United States Pioneer Data Systems Full time

    Job Title: Clinical Data ManagerPioneer Data Systems is seeking a highly skilled Clinical Data Manager to join our team in Cambridge, MA. As a Clinical Data Manager, you will be responsible for overseeing and monitoring digital health technologies and imaging data in clinical trials.Responsibilities:Operational and vendor engagement for BEST and Clinical...

  • Clinical Data Analyst

    1 week ago

    Cambridge, Massachusetts, United States Pioneer Data Systems Full time

    Job Title: Clinical Data AnalystWe are seeking a highly skilled Clinical Data Analyst to join our team at Pioneer Data Systems. As a Clinical Data Analyst, you will play a critical role in supporting the deployment and scaling of digital and imaging solutions into clinical trials.Key Responsibilities:Operational and vendor engagement for BEST and Clinical...

  • Clinical Data Analyst

    2 weeks ago

    Cambridge, Massachusetts, United States Pioneer Data Systems Full time

    Job DescriptionPioneer Data Systems is seeking a highly skilled Clinical Data Analyst to join our team. As a key member of our Digital Health Technology team, you will play a critical role in supporting the operational initiation, vendor and digital data monitoring, and data cleaning process efforts within our clinical trials.Key Responsibilities:Operational...

  • Clinical Data Management and Operations Lead

    3 weeks ago

    Cambridge, Massachusetts, United States Leap Therapeutics Full time

    Job SummaryLeap Therapeutics is seeking a highly experienced Senior Director, Clinical Data Management to lead the development and implementation of clinical data management strategies and processes. This role will be responsible for ensuring the accuracy, completeness, and integrity of clinical data, as well as providing expertise and guidance to...

  • Clinical Data Analyst

    4 weeks ago

    Cambridge, United States Pioneer Data Systems Full time

    Our client, a world-leading Pharmaceutical Company in Cambridge, MA is currently looking for a Clinical Data Analyst to join their expanding team. Position Details: Job Title: Clinical Data Analyst / Digital Health Technology / Pharma Industry Duration: 12 months contract, extendable up to 36 months Location: Cambridge, MA Note: The client has the...

  • Clinical Data Manager

    15 hours ago

    Cambridge, Massachusetts, United States Rangam Full time

    Job Title: Clinical Data ManagerWe are seeking a highly skilled Clinical Data Manager to join our team at Rangam. As a Clinical Data Manager, you will be responsible for overseeing the collection, management, and analysis of clinical trial data. Your primary focus will be on ensuring the quality and integrity of the data, as well as identifying and resolving...

  • Clinical Data Manager

    4 weeks ago

    Cambridge, United States Net2Source Inc. Full time

    Job Title: Clinical Data Manager/ Data Operations ManagerLocation: Cambridge, MA 06340Duration: 24+ Months contractPayrate: $50- $56/hr on w2 without benefitsJob Description: POSITION SUMMARYWe are looking for a self-directed professional to support clinical data management efforts for the Biomeasures Endpoints and Study Technologies (BEST) projects and the...

  • Clinical Data Manager

    4 weeks ago

    cambridge, United States Net2Source Inc. Full time

    Job Title: Clinical Data Manager/ Data Operations ManagerLocation: Cambridge, MA 06340Duration: 24+ Months contractPayrate: $50- $56/hr on w2 without benefitsJob Description: POSITION SUMMARYWe are looking for a self-directed professional to support clinical data management efforts for the Biomeasures Endpoints and Study Technologies (BEST) projects and the...

  • Senior Clinical Data Manager

    2 months ago

    Cambridge, United States PROMETRIKA, LLC Full time

    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 people whose lives have been improved by the innovations we help bring to...

  • Clinical Data Manager

    2 days ago

    Cambridge, United States Rangam Full time

    Position: Clinical Data ManagerPay Scale: $70 - $73 per hourDuration: 12 monthsCandidates MUST currently be local to Cambridge sitePosition SummaryWe are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within clinical trials; specifically focused on the...

  • Senior Clinical Data Manager

    1 week ago

    Cambridge, Massachusetts, United States PROMETRIKA, LLC Full time

    Prometrika LLC Job DescriptionPrometrika LLC 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 people whose lives have been improved by the...

  • Clinical Data Manager

    2 days ago

    Cambridge, United States eTeam Full time

    Title: Clinical Data ManagerLocation: Cambridge - MADuration: 12 Months’Pay Rate: $76/hrPOSITION SUMMARYWe are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within clinical trials; specifically focused on the operational initiation/set-up, vendor and...

  • Clinical Data Manager

    4 weeks ago

    cambridge, United States eTeam Full time

    Title: Data Operations ManagerLocation: Cambridge - MADuration: 12 Months’Pay Rate: $58/hrWork Schedule: Monday - Friday - dayshiftInterview: preferably onsite - Panel with team.POSITION SUMMARYWe are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within...

  • Clinical Data Manager

    4 weeks ago

    cambridge, United States eTeam Full time

    Title: Data Operations ManagerLocation: Cambridge - MADuration: 12 Months’Pay Rate: $58/hrWork Schedule: Monday - Friday - dayshiftInterview: preferably onsite - Panel with team.POSITION SUMMARYWe are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within...

  • Clinical Data Manager

    4 weeks ago

    Cambridge, United States eTeam Full time

    Title: Data Operations ManagerLocation: Cambridge - MADuration: 12 Months’Pay Rate: $58/hrWork Schedule: Monday - Friday - dayshiftInterview: preferably onsite - Panel with team.POSITION SUMMARYWe are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within...

  • Clinical Data Manager

    4 weeks ago

    Cambridge, United States Randstad Life Sciences US Full time

    Clinical Data Manager- First ShiftActual Job Title: Data Operations Manager1 YearCambridge, MAShift: Monday-Friday 8:00am-4:00pm. - 100% ONSITE in CambridgeParking in Cambridge is offsite, and parking expense is not billed back to companyJob DescriptionWe are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable...

  • Clinical Data Manager

    4 weeks ago

    Cambridge, United States Randstad Life Sciences US Full time

    Clinical Data Manager- First ShiftActual Job Title: Data Operations Manager1 YearCambridge, MAShift: Monday-Friday 8:00am-4:00pm. - 100% ONSITE in CambridgeParking in Cambridge is offsite, and parking expense is not billed back to companyJob DescriptionWe are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable...

  • Clinical Data Manager

    4 weeks ago

    cambridge, United States Randstad Life Sciences US Full time

    Clinical Data Manager- First ShiftActual Job Title: Data Operations Manager1 YearCambridge, MAShift: Monday-Friday 8:00am-4:00pm. - 100% ONSITE in CambridgeParking in Cambridge is offsite, and parking expense is not billed back to companyJob DescriptionWe are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable...

  • Clinical Data Manager

    4 weeks ago

    Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Data Operations ManagerLocation: Cambridge, MADuration: 12 monthsM-F- First shiftJob description:We are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within clinical trials; specifically focused on the operational initiation/set-up, vendor and digital...

  • Clinical Data Manager

    4 weeks ago

    Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Data Operations ManagerLocation: Cambridge, MADuration: 12 monthsM-F- First shiftJob description:We are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within clinical trials; specifically focused on the operational initiation/set-up, vendor and digital...