Clinical Research Data Manager job Tempe Arizona
Clinical Research Data Manager job Tempe Arizona
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Clinical Research Data Manager Job



Employer Name: SpiderID: 9731616
Location: Tempe, Arizona Date Posted: 7/28/2020
Wage: Negotiable Category: Medical/Health
Job Code: 356/213

Job Description:

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion offers one of the most experienced clinical pharmacology research networks in the industry.

Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!

The Clinical Data Manager is responsible for the integrity of the data entered into a Celerion system and/or Sponsor provided system. They ensure the database is complete, accurate and consistent and meets quality standards required by Sponsors and regulatory bodies by managing, organizing, and processing clinical data using a range of computer applications and database systems to facilitate collection and cleaning of subject data. They collaborate in multidisciplinary teams involved in setting up, conducting and reporting clinical trials. They are responsible for Sponsor contact, project communication and timeline management for all data management functions.

Essential Functions:



  • Oversight of all clinical data management activities for assigned studies in accordance with SOP's and Procedure Guides

  • Primary Sponsor contact for data management processes on study

  • Responsible for regular communication of study progress with internal and external project team

  • Oversee CRFs from the creation of the blank CRF through delivery of final CRF to sponsor

  • Ensure database is set up per specifications and perform User Acceptance Testing (UAT) of clinical database

  • Coordinate creation of Data Management Plan, CRF Completion Guidelines, Data Validation Plan, and other study documents required per SOP and study needs

  • Manage clinical data cleaning and delivery activities up to and including database lock

  • Review clincal data to ensure accuracy, quality, and integrity of data

  • Generate, resolve, and track queries to address discrepant data identified during review

  • Perform third party data reconciliations

  • Coordinate data transfers (clinical data and vendor related data) with assigned Data Programmer and Sponsor contact

  • Proactively ensure on-time delivery of study deliverables through monitoring of study timeline commitments

  • Manage and appropriately handle/archive all CDM study materials (internally and sponsor specific)

  • Proactively assess project activities and identify issues and/or risk

  • Provide high level customer service to all internal and external clients

  • Perform Quality Control reviews on studies, as needed




Knowledge/Skills/Education/Licenses:



  • High School Diploma or GED/A Level required (relevant internal Celerion experience in lieu required). Relevant BA/BS is highly preferred.

  • 1-2 years industry experience preferred

  • Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred

  • Knowledge of SAS preferred

  • Ability to manage multiple projects/priorities required

  • High attention to detail required

  • Excellent oral and written communication skills required

  • Excellent organizational skills required

  • Proficiency in MS office applications required


Celerion Values: Integrity Trust Teamwork Respect

Are you ready to join our team?

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: Celerion Company Type:
Company: Celerion
City:
State:
Zip:

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