Clinical Data Specialist jobs in New York

Clinical Data Specialist designs and maintains clinical quality databases. Queries databases, creates reports and analyzes data to comply with regulatory reporting requirements and support improvements in clinical effectiveness. Being a Clinical Data Specialist defines and tests new measures, validates data, and takes steps to automate and improve the data collection process. Requires a bachelor's degree. Additionally, Clinical Data Specialist typically reports to a supervisor or manager. The Clinical Data Specialist gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work. To be a Clinical Data Specialist typically requires 2 to 4 years of related experience. (Copyright 2024 Salary.com)

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Clinical Data Management Specialist
  • Axsome Therapeutics
  • New York, NY FULL_TIME
  • Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

    About This Role:

    Axsome Therapeutics is seeking a Clinical Data Management Specialist to support clinical data management activities in compliance with ICH GCP, regulatory guidelines/standards and applicable SOPs. This role supports lead data managers, clinical trial managers (CTMs), clinical research associates (CRAs), and clinical trial associates (CTAs) in all data management related activities (i.e. data review and data entries) across multiple programs. The Clinical Data Management Specialist may also serve as the lead clinical data manager or program lead. This role will report to the Senior Director, Clinical Data Management. 

    This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.  

    Job Responsibilities and Duties include, but are not limited to, the following:

    • Support Data Management oversight of multiple clinical development programs 
    • Serve as primary liaison for Data Management vendor for assigned studies as well as primary resource for study team and monitors 
    • Support the planning and management of data Management timelines 
    • Represent Data Management function on the clinical team meetings ensuring aligned expectations between the vendor and Axsome 
    • Create and maintain study data cleaning trackers 
    • Ensure achievement of major Data Management deliverables and milestones in coordination with other functions including Clinical Operations, Safety, Statistics, etc. 
    • Maintain all Data Management documentation to ensure inspection readiness of all Data Management Trial Master File (TMF) documents 
    • Draft/review Data Management Plans, data entry guidelines, Data Management reports, validation plans, lab reconciliations and other DM and study specific documents  
    • Support the development of Case Report Forms (CRFs) and edit checks per protocol and performs user acceptance testing of CRFs and co-develops associated edit check specifications as required 
    • Assist in preparing clean databases by performing reviews of clinical trial data through electronic data capture (EDC) and or data listings 
    • Generate queries, data listings, metrics, quality reports to appropriate internal or external personnel (i.e. investigational sites, vendors, Clinical Research Associates) to assist in overseeing quality and resolve problematic data identified during every aspect of the data management process 
    • Review responses to queries for appropriateness and resolution to ensure high data quality 
    • Generate custom safety listings and presents to Medical Monitor and study team 
    • Gather metrics to support risk-based monitoring 
    • Responsible for training of Clinical Trial Associates (CTAs)/Clinical Program Coordinators (CPCs) on data management activities 

    Requirements / Qualifications

    • Bachelor’s degree required. Preference to candidates with a life science degree 
    • At least 3 years’ data management experience in a biotech/pharmaceutical company or clinical research organization (CRO), or clinical research site with Data Management focus or related duties 
    • Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles 

    Experience and Knowledge:

    • Good understanding of FDA, GCP and ICH guidelines 
    • Experience with electronic data capture (EDC) systems/technologies as applied to clinical trials 
    • Good working knowledge of (e)CRF design and data management functions/activities 
    • Good working knowledge of Microsoft Office software and apps with strong knowledge of Excel. A plus if proficient with data visualizations and database concepts 
    • Ability to handle multiple clinical programs simultaneously 
    • Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities 
    • Preference to strong work ethic, energetic candidates with a desire to think “outside the box” 
    • Strong attention to detail, time management, and excellent organizational skills 

    Salary and Benefits:

    The anticipated salary range for this role is $85,000 - $95,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

    Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. 

  • 16 Days Ago

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Customer Support Specialist
  • PitchBook Data
  • New York, NY FULL_TIME
  • About the Role: As a member of our Account Management & Customer Success team, you will thrive on your ability to embrace and drive change and your commitment to ensuring you and PitchBook are always ...
  • 1 Month Ago

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Cath lab Clinical Nurse Specialist
  • Clinical Management Consultants
  • Huntington, NY FULL_TIME
  • An exciting opportunity is now available in beautiful Long Island, NY as Cath lab Clinical Nurse Specialist. The Cath lab Clinical Nurse Specialist will become a member of a 300 bed hospital that has ...
  • 2 Days Ago

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Cath lab Clinical Nurse Specialist
  • Clinical Management Consultants
  • Queens Village, NY FULL_TIME
  • An exciting opportunity is now available in beautiful Long Island, NY as Cath lab Clinical Nurse Specialist. The Cath lab Clinical Nurse Specialist will become a member of a 300 bed hospital that has ...
  • 12 Days Ago

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Cardiovascular Data Registry Coordinator
  • Clinical Management Consultants
  • Pomona, NY FULL_TIME
  • An acute care hospital in beautiful New York is looking to add a Cardiovascular Data Registry Coordinator to their growing team! This 200 bed hospital is known for providing competent, innovative, and...
  • 6 Days Ago

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Cardiovascular Data Registry Coordinator
  • Clinical Management Consultants
  • Harriman, NY FULL_TIME
  • An acute care hospital in beautiful New York is looking to add a Cardiovascular Data Registry Coordinator to their growing team! This 200 bed hospital is known for providing competent, innovative, and...
  • 18 Days Ago

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Clinical Data Specialist
  • Katalyst HealthCares and Life Sciences
  • Irvine, CA
  • Responsibilities: Independently ensure all study data is validated in accordance with regional and federal clinical stud...
  • 3/28/2024 12:00:00 AM

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Sr. Rad Tech, Sat - Sun (6:30a-11p) & Mon (2:30p-11p)
  • Memorial Hermann Health System
  • Houston, TX
  • At Memorial Hermann, we pursue a common goal of delivering high quality, efficient care while creating exceptional exper...
  • 3/28/2024 12:00:00 AM

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Health Data Specialist II
  • Biogensys
  • Trenton, NJ
  • Job Description Job Description We are hiring Health Data Specialist II (USTF/BEDS) for one of our clients in Hamilton, ...
  • 3/27/2024 12:00:00 AM

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Clinical Data Specialist
  • PRC Baker Places
  • San Francisco, CA
  • Job Description Job Description PRC Baker Places is a non-profit residential treatment agency that has provided the San ...
  • 3/27/2024 12:00:00 AM

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Clinical Data Specialist
  • PRC Baker Places
  • San Francisco, CA
  • Job Description Job Description PRC Baker Places is a non-profit residential treatment agency that has provided the San ...
  • 3/27/2024 12:00:00 AM

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Clinical Data Specialist I, Inpatient/Outpatient - Redcap
  • Memorial Sloan
  • New York, NY
  • Clinical Data Specialist I, Inpatient/Outpatient - Redcap 2956 Job Locations USA-NY-New York Requisition ID 2024-76048 C...
  • 3/27/2024 12:00:00 AM

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Health Data Analyst
  • Biogensys
  • Trenton, NJ
  • Job Description Job Description Biogensys is hiring a Health Data Specialist II for one of our clients in Trenton, NJ fo...
  • 3/27/2024 12:00:00 AM

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Clinical Data Liaison (mainly remote, New England based)
  • University of Massachusetts Medical School
  • Worcester, MA
  • Overview: POSITION SUMMARY: The Clinical Data Liaison is responsible for all of the day-to- day clinical reporting and r...
  • 3/24/2024 12:00:00 AM

New York is a state in the Northeastern United States. New York was one of the original thirteen colonies that formed the United States. New York covers 54,555 square miles (141,300 km2) and ranks as the 27th largest state by size.[3] The highest elevation in New York is Mount Marcy in the Adirondacks, at 5,344 feet (1,629 meters) above sea level; while the state's lowest point is at sea level, on the Atlantic Ocean. In contrast with New York City's urban landscape, the vast majority of the state's geographic area is dominated by meadows, forests, rivers, farms, mountains, and lakes. Most of...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Clinical Data Specialist jobs
$64,532 to $91,525

Clinical Data Specialist in Rockford, IL
Homa Assadi has joined as Clinical Research Scientist and Data Specialist, at their head office and research site in Toronto, Canada.
January 14, 2020
Clinical Data Specialist in Stockton, CA
Clinical data entry and processing of prescription prior authorizations for multiple practices.  Runs reports to collect data to enter into EMR flow sheets.
January 29, 2020
Clinical Data Specialist in Toledo, OH
Manage, review and maintain Data Management Plans and other study related documentation.
December 17, 2019