Clinical Data Manager I

1 week ago


New Haven, Connecticut, United States inviCRO Full time
Clinical Data Manager I - New Haven, CT/Remote

Overview:

The Clinical Data Manager is responsible for delivery of an entire clinical trial. Is sponsor facing and works with study project managements and technical data management team to meet the design specs, monitor the health of the trial, ensure quality and data reconciliation.

Essential Functions:
  • Ensures clinical trial databases meet project requirements by:
  • Attending and participating in sponsor meetings
  • Managing all data management deliverables for assigned studies
  • Ensures the plan for data management is properly executed by:
  • Understanding the requirements for study implementation and data collection
  • Collaborating with project team to develop study-specific edit check criteria
  • Defining, running, and reviewing edit checks and resolving discrepant data
  • Maintaining organized, complete, and up-to-date study documentation
  • Performing study setup, specifications, and obtaining approvals as needed
  • Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors).
  • Keeping supervisor informed of project status
  • Ensures the accuracy and consistency of clinical databases by:
  • Reviewing data and identifying errors/inconsistencies
  • Collaborating with appropriate project team to resolve data issues
  • Tracking outstanding issues and following-up until resolution
  • Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines
  • Other duties as assigned
Qualifications:
  • Bachelor's degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required
  • 1 - 2 years' experience in comparable position within
  • Working knowledge of relational database organization and validation
  • Proven ability in problem solving
Preferred
  • the pharmaceutical, biotech or CRO industry experience preferred
  • Understanding of clinical trial terminology desirable
  • Familiarity with SAS desirable
  • Experience working with office productivity tools including Word, Excel and Access preferred
About us:

Headquartered in Boston, MA, Invicro was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro's multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro's quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by the company's industry-leading software informatics platforms, VivoQuant and iPACS, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ.

Invicro is an Equal Opportunity Employer. We maintain a drug-free work environment. All qualified applicants will receive consideration for employment without regard to actual or perceived race (and traits historically associated with race, including, but not limited to hair texture and protective hairstyles such as braids, locks, and twists), color, creed, religion, citizenship status, sex or gender (including pregnancy, childbirth and related medical conditions), parental status, sexual orientation, gender identity, gender expression (including transgender status), national origin, ancestry, age, marital status or protected veteran status and will not be discriminated against on the basis of physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, political affiliation or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Invicro does not accept unsolicited resumes from individual recruiters, third party recruiting agencies, outside recruiters or firms without an executed contract in place. We are not responsible for any fees related to resumes that are unsolicited or are received by Invicro. Such resumes will be deemed the sole property of Invicro and will be processed accordingly.

#LI-MK1 #LI-Remote

  • New Haven, Connecticut, United States Celldex Full time

    OverviewJoin a well-established and collaborative Clinical Operations team in a Clinical Trial Manager role with opportunity for career enrichment. As the operational leader of the study team, the Clinical Trial Manager (CTM) works closely with internal team members and vendors ensuring clinical trials are completed according to protocol, SOPs,...


  • New Haven, Connecticut, United States Fair Haven Community Health Care Full time

    Fair Haven Community Health Care FHCHC is a forward-thinking, dynamic, and exciting community health center that provides care for multiple generations at nearly 140,000 office visits in 19 locations. Overseen by a Board of Directors, the majority of whom are patients themselves, we are proud to offer a wide range of primary and specialty care services, as...


  • New Haven, Connecticut, United States Connecticut Innovations Full time

    Come join Veradermics, a Connecticut Innovations portfolio company About Veradermics Veradermics is a well-funded medical dermatology company driven to develop innovative therapeutics aimed at transforming the standard of care for a wide range of common skin conditions. Founded by dermatologists, Veradermics leverages its front-line clinical experience to...


  • New Haven, Connecticut, United States Connecticut Innovations Full time

    Come join Veradermics, a Connecticut Innovations portfolio company About VeradermicsVeradermics is a well-funded medical dermatology company driven to develop innovative therapeutics aimed at transforming the standard of care for a wide range of common skin conditions. Founded by dermatologists, Veradermics leverages its front-line clinical experience to...


  • New Haven, Connecticut, United States Yale University Full time

    Essential DutiesServes as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols. 2. Manages, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration. 3. Contributes to study feasibility reviews and makes...

  • Data Coordinator 2

    1 week ago


    New Haven, Connecticut, United States Yale University Full time

    Data Coordinator 2: Comprehensive Cancer Center Clinical Trial Operations 88441BRUniversity Job Title Research Assistant 2 HSSBargaining Unit L3 Local 34 (Yale Union Group)Time Type Full timeDuration Type RegularCompensation Grade Labor Grade DWage Ranges Click here to see our Wage RangesSearchable Job Family Clinical, Research Res Support,...

  • Clinical Tech

    1 week ago


    New Haven, Connecticut, United States Yale New Haven Health Full time

    Overview:To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.Under the direct supervision of the RN or Patient Care...


  • New Haven, Connecticut, United States Connecticut Innovations Full time

    Come join Halda Therapeutics, one of our portfolio companies Halda TherapeuticsHalda Therapeutics is a New Haven CT based, venture-backed biotechnology company focused on the development of a proprietary RIPTACTM (Regulated Induced Proximity TArgeting Chimeras) therapeutics that work by a novel "hold and kill" mechanism for the precision treatment of cancer....


  • New Haven, Connecticut, United States Yale University Full time

    Essential DutiesServes as the primary oversight specialist on clinical and operational processes for low to moderately complex studies and non-therapeutic trials. Serves as a supporting clinical research coordinator to CRC/CRN II and Sr. CRC/CRN for highly complex protocols. 2. Manages, implements, and evaluates all aspects of clinical trial conduct...


  • New Haven, Connecticut, United States Saint Francis Health System Full time

    Current Saint Francis Employees - Please click HERE to login and apply. Full Time Job Summary: The Senior Data Integration Developer will design, develop, test, implement and support ETL/ELT (extract, load, transform) processes that pull data from various source systems and integrate it into the data warehouse. This role will lead other team members and...

  • Clinical Scheduler

    4 weeks ago


    New Haven, Connecticut, United States Yale University Full time

    11-Dec-2023Neurosurgery – Clinical Operations 85540BRUniversity Job TitleClinical Receptionist 2Bargaining UnitL34 – Local 34 (Yale Union Group) Compensation GradeLabor Grade C Wage RangesClick here to see our Wage Ranges Searchable Job FamilyClinical, SecretarialTotal # of hours to be worked:37.5Work WeekStandard (M-F equal number of hours per day)...

  • Clinical Scheduler

    1 week ago


    New Haven, Connecticut, United States Yale University Full time

    11-Dec-2023Neurosurgery – Clinical Operations 85540BRUniversity Job TitleClinical Receptionist 2Bargaining UnitL34 – Local 34 (Yale Union Group) Compensation GradeLabor Grade C Wage RangesClick here to see our Wage Ranges Searchable Job FamilyClinical, SecretarialTotal # of hours to be worked:37.5Work WeekStandard (M-F equal number of hours per day)...

  • Clinical Scheduler

    4 weeks ago


    New Haven, Connecticut, United States Yale University Full time

    11-Dec-2023Neurosurgery – Clinical Operations 85540BRUniversity Job TitleClinical Receptionist 2Bargaining UnitL34 – Local 34 (Yale Union Group) Compensation GradeLabor Grade C Wage RangesClick here to see our Wage Ranges Searchable Job FamilyClinical, SecretarialTotal # of hours to be worked:37.5Work WeekStandard (M-F equal number of hours per day)...


  • West Haven, Connecticut, United States GHP Media, Inc. Full time

    Works with customer supplied data to produce personalized printed materials and to make variable data product available on the digital storefront (DSF) Manages a team of 14, consisting of Inserter Operators, Inkjet Operators, Mailing Data Specialists and Mailing Administrators.


  • New Haven, Connecticut, United States Yale University Full time

    The Cardiovascular Data Science (Car. DS) Lab at Yale University is currently seeking a Clinical Research Coordinator to join our team. This role offers an opportunity to engage in a range of exciting projects aimed at enhancing patient care through Clinical Research, Research Coordinator, Clinical, Coordinator, Research, Cardiovascular, Healthcare


  • New Haven, Connecticut, United States Catholic Charities, Archdiocese of Hartford Full time

    Do you have a passion for helping others with mental health and substance use issues? Are you an experienced, culturally competent clinical leader who is looking for an opportunity to make a true difference in the lives of others? If so, the Director of Clinical Services is the right position for you. This position oversees two sites - our Waterbury and New...


  • New Haven, Connecticut, United States Yale-New Haven Health Full time

    OverviewTo be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.The Clinical Social Worker I is a licensed, experienced...


  • New Haven, Connecticut, United States XingImaging, A Mitro Company Full time

    Job DescriptionJob DescriptionPosition OverviewThis is a permanent, onsite full-time position in our New Haven, Connecticut facility.The Clinical Research Coordinator (CRC) will oversee the execution of research studies according to established study protocols. Responsibilities include study start-up, screening, eligibility determination, registration, and...


  • New Haven, Connecticut, United States Yale School of Medicine Full time

    Position Focus: Yale University seeks an exceptional People Data Scientist to join our People Analytics team, part of the HR Innovation & Strategic Support (HRISS) unit. In this pivotal role, you will play a key part in transforming our people data infrastructure, driving valuable insights that shape workforce decisions. The Yale HRISS team fosters a...


  • New Haven, Connecticut, United States Saint Francis Health System Full time

    Current Saint Francis Employees - Please click HERE to login and apply.This position is ECB status - requires a minimum number of worked hours per month as needed by the department; limited benefit offerings.Job Summary: Identifies, processes, and documents laboratory specimens for the purpose of assessing and monitoring patient statusMinimum...