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Become A Clinical Data Specialist

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Working As A Clinical Data Specialist

  • Processing Information
  • Interacting With Computers
  • Documenting/Recording Information
  • Getting Information
  • Communicating with Supervisors, Peers, or Subordinates
  • Mostly Sitting

  • Repetitive

  • $78,050

    Average Salary

What Does A Clinical Data Specialist Do At University of Pennsylvania

* Develops and oversees the implementation of onsite and remote data safety monitoring plans (DSMPs) to ensure study participant safety and document data quality; continually evaluate EDCs and CRFs for required modification due to dynamic nature of research studies; coordinate and provide guidance to junior CRCs for initiation, interim, and closeout visits with external study sites.
* Data Analyses: Create data sets from internal and external data sources, perform statistical programming and analyses under the guidance of the senior biostatistician; learning new statistical techniques, support writing of manuscripts for peer reviewed journals
* Study Enrollment Tracking Responsibilities: Develop and implement recruitment tracking methods for 40
* study sites.
* Monitoring enrollment milestones and create and present reports to research team, lead investigators, and study sponsors.
* Support and communicate with principal investigators, co-investigators, project manager, and other coordinators as needed for the successful execution of the clinical trials
* Operations Oversight Responsibilities: Develop plans and systems to oversee dosing protocol compliance, adverse event reporting, and data collection at 40
* study sites.
* Direct and oversee the efforts of junior CRCs on the drafting and maintenance of study guidance documentation (e.g.
* MOPs, lab manual, data management plans, data system SOPs, etc.).
* Performing additional duties as assigned
* Adhering to all University of Pennsylvania, GCP, ICH, and FDA guideline
* Qualifications
* The qualifications required for the Clinical Data Specialist position include:
* The minimum of a BS/BA with concentrations/majors/minors preferably in health, science, clinical data management, applied mathematics, statistics, informatics, or computer science and 3
* years of experience in clinical research and database management, or an equivalent combination of education and experience required, Master’s degree preferred
* Knowledge of IRB and Human Research Protection Regulations
* Working knowledge of electronic data capture systems, database design, and data management required.
* Preference given to candidates with demonstrated knowledge and programming experience in UNIX, R, SQL, and PYTHON.
* Ability to follow detailed clinical research protocols
* Excellent organization skills and demonstrated attention-to-detail
* Affirmative Action Statement
* Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class

What Does A Clinical Data Specialist Do At Stanford University

* Maintain existing databases and develop guidelines to ensure data integrity; may integrate data from several sources.
* Identify and select usable data from extremely subtle and complex data patterns, applying practical understanding.
* Utilize computer applications to manipulate and report complex data.
* Develop new tools to assist with data collection and analysis.
* Work with data providers to discuss and clarify data ambiguities, inconsistencies etc.
* Perform audits of own work or that of others to ensure conformance with established procedure.
* Select and apply appropriate formulas, computer programs, or applications depending on data content.
* Establish complex record-keeping procedures, including cross-indexing by several factors and the designing of necessary forms.
* Keep current in changes and innovations in clinical knowledge, user applications, and reporting requirements in the field of blood and marrow transplant.
* Other duties may also be assigned
* Qualifications

What Does A Clinical Data Specialist Do At Cepheid

* Responsible for activities of clinical trial data management including query generation/processing, reconciliation of CRF and electronic data, and database cleaning activities.
* Assist in developing systems for organizing data to analyze, identify and report trends.
* Work with CRAs and statistical department to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams.
* Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem

What Does A Clinical Data Specialist Do At Tech Observer

* Support development of DM study documentation, including: Data Management Plans, annotated CRFs and specifications, CRF Completion Guidelines, Data Transfer Plans, etc.
* Support User Acceptance Testing of databases Utilize and test both system and non-system edit checks Support medical coding and facilitate reviews Support SAE reconciliation Support data cleaning activities Provide DM infrastructure support as needed Support non
* CRF data (labs, etc

What Does A Clinical Data Specialist Do At Vanderbilt University Medical Center

* Data Management
* Inputs, reviews and submits eligibility documentation into data capture systems for a portfolio of studies.
* Identifies and resolves any documentation discrepancies.
* Correctly and efficiently abstracts information from the EMR for multiple studies.
* Able to manage additional assignments as needed for fast accruing studies.
* Identifies AEs from EMR, provides support to correctly and completely record AEs and serves as resource to Data Specialist staff.
* Assists with trending reports on AEs for each trial and across teams.
* Submits to sponsor all pertinent data into database accurately and efficiently for Phase I/II/III trials.
* Reviews and approves responses to sponsor queries from Data Specialists.
* Supports complex queries and works with sponsors on issues; supports initiatives to reduce queries through identification on ongoing issue
* External Sponsor Monitoring and Visit Management
* Coordinates monitor scheduling for multiple studies, including fast accruing studies with increased monitoring demand and studies with data locks for FDA submissions and/or national meeting presentations.
* Meets with monitors to review data monitoring results, answer questions and resolve queries.
* Demonstrates effective communication with external monitors.
* Mentors data team on resolving issues.
* Quality Assurance/Internal Monitoring
* Queries research team to clarify, reconcile and complete data issues.
* Develops assessment tools to assist clinical staff during patient visits.
* Mentors and trains Data Specialist staff to communicate effectively with the research team as needed.
* Identifies and resolves discrepancies with research team.
* Mentors and assists data team in effective discrepancy resolution as needed.
* Coordinates data entry, data lock, and monitoring and audit deadlines for multiple studies.
* Trains Data Specialists staff in good clinical and research practices as it relates to data management as needed.
* Encourages input as it relates to process improvement.
* Prepares for and participates in clinical trial audits.
* Mentors and trains Data Specialist staff to prepare for and participate in internal and external audits as needed.
* JOB CODE INFORMATION:
* Job Code: 3748
* Job Stream Description: TBD

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How To Become A Clinical Data Specialist

Statisticians typically need at least a master’s degree in statistics, mathematics, or another quantitative field. However, a bachelor’s degree is sufficient for some entry-level jobs. Research and academic jobs generally require a Ph.D.

Education

Statisticians typically need at least a master’s degree, although some entry-level jobs are available for those with a bachelor’s degree. Most statisticians have degrees in mathematics, economics, computer science, or another quantitative field. A bachelor’s degree in statistics typically includes courses in linear algebra, calculus, experimental design, survey methodology, probability, and statistical theory.

Many colleges and universities advise students to take courses in a related field, such as computer science, engineering, physics, or mathematics. These courses can help prepare students to work in a variety of industries. Coursework in engineering or physical science, for example, may be useful for statisticians working in manufacturing on quality or productivity improvement. A background in biology, chemistry, or health sciences is useful for work testing pharmaceutical or agricultural products.

Because statisticians often work with data analysis software, computer programming courses may be particularly beneficial for students.

Important Qualities

Analytical skills. Statisticians use statistical techniques and models to analyze large amounts of data. They must determine the appropriate software packages and understand computer programming languages to design and develop new techniques and models. They must also be precise and accurate in their analyses.

Communication skills. Statisticians often work with, and propose solutions to, people who do not have extensive knowledge of mathematics or statistics. They must be able to present statistical information and ideas so that others will understand.

Math skills. Statisticians use statistics, calculus, and linear algebra to develop their models and analyses.

Problem-solving skills. Statisticians must develop techniques to overcome problems in data collection and analysis, such as high nonresponse rates, so that they can draw meaningful conclusions.

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Clinical Data Specialist jobs

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Clinical Data Specialist Demographics

Gender

  • Female

    71.6%
  • Male

    25.5%
  • Unknown

    2.9%

Ethnicity

  • White

    73.7%
  • Asian

    11.2%
  • Hispanic or Latino

    10.5%
  • Unknown

    2.6%
  • Black or African American

    2.0%
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Languages Spoken

  • Spanish

    47.4%
  • Amharic

    10.5%
  • Gujarati

    5.3%
  • Japanese

    5.3%
  • Urdu

    5.3%
  • Carrier

    5.3%
  • Hindi

    5.3%
  • Tagalog

    5.3%
  • Russian

    5.3%
  • Arabic

    5.3%
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Clinical Data Specialist

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Clinical Data Specialist Education

Clinical Data Specialist

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Real Clinical Data Specialist Salaries

Job Title Company Location Start Date Salary
Clinical Operations Data Analytics Specialist .01) Advanced Clinical Holdings LLC Cambridge, MA Dec 15, 2016 $125,220
Clinical Operations Data Analytics Specialist .01) Advanced Clinical Holdings LLC Cambridge, MA Nov 20, 2016 $124,800
Clinical Operations Data Analytics Specialist .01) Advanced Clinical Holdings LLC Cambridge, MA Aug 20, 2016 $124,800
Clinical Data Specialist Veracyte, Inc. South San Francisco, CA Jul 15, 2016 $115,000
Senior Clinical Data Specialist II Shire Human Genetic Therapies, Inc. Lexington, MA Mar 04, 2013 $96,304
PR. Clinical Data Specialist Medtronic, Inc. Mounds View, MN Nov 30, 2015 $93,746 -
$101,580
SR. Clinical Data Specialist Medtronic, Inc. Mounds View, MN May 30, 2015 $91,514
SR. Clinical Data Specialist Medtronic, Inc. Fridley, MN Apr 30, 2015 $91,500
Senior Clinical Data Specialist Stryker Corporation Fremont, CA Feb 23, 2011 $89,000 -
$100,000
Senior Clinical Data Specialist Boston Scientific Corporation Fremont, CA Aug 30, 2010 $89,000 -
$100,000
Clinical Data Specialist, Vascular The New York and Presbyterian Hospital New York, NY Feb 15, 2016 $84,802 -
$95,000
Clinical Data Specialist, Vascular The New York and Presbyterian Hospital New York, NY Feb 17, 2016 $84,802 -
$95,000
Clinical Data Specialist Maxisit, Inc. Metuchen, NJ Feb 06, 2012 $83,480
Clinical Data Specialist Maxisit, Inc. Metuchen, NJ Apr 12, 2012 $83,480
Clinical Data Specialist Maxisit, Inc. Metuchen, NJ Mar 09, 2011 $83,480
Clinical Data Specialist Maxisit, Inc. Metuchen, NJ Nov 12, 2010 $83,480
Clinical Data Specialist Vividstarts LLC Marlborough, MA Sep 01, 2015 $83,200
Clinical Data Analystvendor Feather Technologies, Inc. Cary, NC Sep 04, 2015 $80,000
Clinical Data Specialist Medtronic, Inc. Mounds View, MN Jun 06, 2016 $76,100
SR. Clinical Data Specialist Medtronic, Inc. Mounds View, MN May 14, 2012 $73,674 -
$86,000
Clinical Research Data Specialist II Cedars-Sinai Medical Center Los Angeles, CA Apr 18, 2016 $71,885
Clinical Data Specialist Cincinnati Children's Hospital Medical Center Cincinnati, OH Sep 28, 2013 $71,323
Senior Clinical Data Specialist Shire Human Genetic Therapies, Inc. Cambridge, MA Mar 05, 2010 $68,000 -
$80,000
Clinical Data Specialist Smithhanleyconsultinggroupllc, A Div. of Inventiv Brookline, MA Jun 14, 2010 $66,596 -
$52
Clinical Data Specialist Unicon Pharma Inc. Durham, NC Oct 11, 2016 $65,790
Functional/Clinical Data Specialist Brite Systems, Inc. Phoenix, AZ Sep 01, 2015 $55,000

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Top Skills for A Clinical Data Specialist

DatabaseLockDataManagementProcessesProceduresClinicalTrialDataMedicalRecordsCRFDataEntryGuidelinesLabRegulatoryDataQueriesDataReviewAdverseEventsFDADataCollectionResearchStudyEditChecksUATMedicalChartsSASUserAcceptance

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Top Clinical Data Specialist Skills

  1. Database Lock
  2. Data Management Processes
  3. Procedures
You can check out examples of real life uses of top skills on resumes here:
  • Performed clinical review of the patient profiles & listings prior to database lock.
  • Provided training to subordinates for all standard data management processes.
  • Schedule study procedures, attend clinic visits, and educate participants.
  • Participate with multidisciplinary teams involved in the initiation, operation, and reporting of clinical trial data.
  • Applied data element definitions and abstraction instructions found in applicable manuals to accomplish timely and accurately review of selected Medical Records.

Top Clinical Data Specialist Employers