Clinical Data Manager

Employment Type

: Full-Time

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NYU School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on Facebook, Twitter and Instagram.

Position Summary:
We have an exciting opportunity to join our team as a Clinical Data Manager.

In this role, the successful candidate EPPIC-Net is a network that will include a Data Coordinating Center (DCC), Clinical Coordinating Center (CCC), and ten Specialized Clinical Centers (SCCs). The DCC will work with Federal government partners to conduct high-quality efficient clinical trials to develop non-addictive treatments for pain as part of the Helping to End Addiction Long-term (HEAL) initiative. The DCC will provide a range of coordinating services for this NIH-funded network, including statistical and data management; collection of clinical, biomarker and imaging data; and establishment of repositories for biospecimens and biomedical images.
The Clinical Data Manager will work closely with the EPPIC-Net DCCs Principal Investigator, Data Management Leadership, and key stakeholders in supporting clinical trials from inception to completion. S/he will play a key role in developing study protocols, locking study databases, and packaging data for final analyses. In particular, s/he will ensure that study databases are built and maintained in accordance with Good Clinical Practices (GCP), Food and Drug Administration (FDA), Clinical Data Interchange Standards Consortium (CDISC) guidelines, and EPPIC-Net SOPs. S/he will also review study data to ensure accuracy, timeliness, and completeness. Lastly, s/he will lead internal initiatives to assess and continuously improve EPPIC-Nets Clinical Data Management processes.

Job Responsibilities:

  • Develop and update data management-related documents, including but not limited to Data Management Plans (DMP), standards library/data dictionary for the DCC, and Data Transfer Agreements (DTAs).
  • Coordinate with EPPIC-Net hub personnel in effectuating data transfers.
  • Assist in developing protocols/workflows to communicate and resolve data quality issues and trends that may arise during the study.
  • Create data entry completion guidelines document based on the final database and work closely with CCC personnel to ensure that all site personnel receive thorough training on the appropriate use of systems.
  • Work closely with the PI and Data Management leadership in designing standard CRF domains based on the DCCs predefined data standardization strategy.
  • Lead data specifications assessment for required eCRF customizations as new studies are on-boarded; at the CRF design phase, collaborate with corresponding study team representatives from the DCC, CCC, and hubs to create CRF specifications based on the study protocol and the schedule of assessments.
  • Train site personnel on use of the EDC system, and particularly: conduct initial EDC and eCRF training prior to the sites first participant enrollment; lead periodic refresher training sessions throughout the duration of the study; address site inquiries regarding the eCRFs and EDC system.
  • Work with DCC and site personnel to ensure that data collected for the study are complete, accurate, and meet analysis specifications; specifically, review data validation reports to determine the frequency and nature of data quality issues, including identification of trends in data collection patterns within and across sites; identify and report invalid data, missing data, data that do not meet analysis specifications, and data in conflict with the within- and across-record logic checks; review study data longitudinally for consistency and identify outliers that exceed actual and logical limitations of each data element.
  • In collaboration with DCC and site personnel, resolve data quality issues through completion to ensure data completeness and accuracy.
  • As necessary, participate in regular calls and meetings with personnel from the DCC, hubs, and sites.

Minimum Qualifications:
To qualify you must have a Typically requires 4 or more years of experience and BA/BS degree or equivalent.

Preferred Qualifications:
Experience with EDC software such as REDcap and other commercial systems (e.g., Medidata, Inform, TrialMaster, Velos, etc.). Certified Clinical Data Manager (CCDM) credential desired. Experience with creating data entry and query screens/processes and data quality checks. Knowledge of and experience with electronic data capture (EDC) and database management systems. Proficiency in office automation programs, including but not limited to word processing, spreadsheets, etc. Ability to manage multiple projects, tasks, and priorities; work independently with minimal supervision and execute tasks to completion without a great deal of direction. Experience in training users in operation of clinical trials systems and tools. Ability to exercise judgment, initiative, and resourcefulness in making decisions in consultation with clinical research personnel, and independently if necessary. Ability to work with personnel who have varying degrees of technical expertise. Demonstrated strong teamwork and organizational skills; outstanding interpersonal and communication skills.

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.

NYU School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
If you wish to view NYU School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.

Position Summary:
EPPIC-Net is a network that will include a Data Coordinating Center (DCC), Clinical Coordinating Center (CCC), and ten Specialized Clinical Centers (SCCs). The DCC will work with Federal government partners to conduct high-quality efficient clinical trials to develop non-addictive treatments for pain as part of the Helping to End Addiction Long-term (HEAL) initiative. The DCC will provide a range of coordinating services for this NIH-funded network, including statistical and data management; collection of clinical, biomarker and imaging data; and establishment of repositories for biospecimens and biomedical images.
The Clinical Data Manager will work closely with the EPPIC-Net DCCs Principal Investigator, Data Management Leadership, and key stakeholders in supporting clinical trials from inception to completion. S/he will play a key role in developing study protocols, locking study databases, and packaging data for final analyses. In particular, s/he will ensure that study databases are built and maintained in accordance with Good Clinical Practices (GCP), Food and Drug Administration (FDA), Clinical Data Interchange Standards Consortium (CDISC) guidelines, and EPPIC-Net SOPs. S/he will also review study data to ensure accuracy, timeliness, and completeness. Lastly, s/he will lead internal initiatives to assess and continuously improve EPPIC-Nets Clinical Data Management processes.

Minimum Qualifications:
Typically requires 4 or more years of experience and BA/BS degree or equivalent.

Preferred Qualifications:
Experience with EDC software such as REDcap and other commercial systems (e.g., Medidata, Inform, TrialMaster, Velos, etc.). Certified Clinical Data Manager (CCDM) credential desired. Experience with creating data entry and query screens/processes and data quality checks. Knowledge of and experience with electronic data capture (EDC) and database management systems. Proficiency in office automation programs, including but not limited to word processing, spreadsheets, etc. Ability to manage multiple projects, tasks, and priorities; work independently with minimal supervision and execute tasks to completion without a great deal of direction. Experience in training users in operation of clinical trials systems and tools. Ability to exercise judgment, initiative, and resourcefulness in making decisions in consultation with clinical research personnel, and independently if necessary. Ability to work with personnel who have varying degrees of technical expertise. Demonstrated strong teamwork and organizational skills; outstanding interpersonal and communication skills.


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