Electronic Data Capture Data Manager

Role Description

JOB TITLE:

EDC Data Manager, Associate

Statistics and Data Management, Automation and Data Sciences

Veterinary Medicine Research & Development (VMRD)

May consider remote*

POSITION RESPONSIBILITIES:

The successful applicant embodies Zoetis' Core Beliefs: Our Colleagues Make The Difference, Always Do The Right Thing, Customer Obsessed, Run It Like You Own It, and We Are One Zoetis.

Within Veterinary medicine Research and Development (VMRD), the candidate will be a member of the global electronic data capture (EDC) and data management (DM) teams. Candidate will assist in electronic data capture system and data management tasks associated with clinical studies to support global VMRD Projects.

Specific responsibilities may include, but are not limited to:

• DM and EDC assistance with multiple internal partner groups to review study protocols, coordinate and develop data capture and storage specifications for study data
• Assist and manage the building and coordinating of Zoetis' clinical studies in an eClinical. electronic data capture system (EDC)
• Assist to organize electronic data for government regulatory submissions and respond to internal/external audits.
• Provide study-specific database and setup within an EDC system
• Perform process-specific requests involving study data maintained by these systems such as data imports, data corrections, data pack unlocks, edit checks, and data cleaning.
• Management of the library of data forms that are used to capture study data
• Program data ingestion and transformation tasks, including automating ingestion pipelines for use across clinical studies
• Troubleshoot data and EDC issues with customers through ad-hoc investigations
• Serve as the principal communication link between the EDC and DM teams, other VMRD groups, and external partners
• Support and training for internal and external study personnel in the use of EDC and DM systems
• Administrative support activities including but not limited to:
  • Managing multiple Outlook Calendars
  • Maintaining internal DM and EDC tracking systems
  • Performing initiation and archival of EDC studies
  • Managing and maintaining the eClinical solution's user access

General:

• Minimal evening and/or weekend system support required
• Travel: approximately 5% on an annual basis.(Variable, depending upon project status.)

QUALIFICATIONS

Educational Background:

Minimum: Bachelor's degree

Desirable: Master's degree

Desired degree in the following areas:

• Information Management
• Computer Science
• Bioinformatics
• Data Science and/or Data Analytics
• Animal Science/Husbandry
• Biomedical Sciences
• Biotechnology

Work Experience/Skills:

Minimum:

• Experience with eClinical Solutions and electronic data management/capture systems in a clinical or research environment.
• Experience designing data tables that correspond to forms used for data collection
• Experience reading electronic files into data sets and producing reports or visualizations on that data
• Ability to work both as a member of a team and independently in a self-directed and self-motivated manner.
• Proven ability to lead or work on several simultaneous projects or activities
• Excellent skills in the following competencies: organizing, planning, time management, quality, attention to detail.
• Well-developed critical thinking skills with the ability to problem solve and provide solutions to study team challenges.
• Excellent interpersonal skills with very good written and oral communication skills.
• Competence with Microsoft Office Products.

Desirable:

• Experience in Pharmaceutical R&D (Human Health or Animal Health) in a clinical data management and/or electronic data capture specialty
• Previous experience in the preparation of electronic data for regulatory submissions.
• Knowledge or experience designing databases that correspond to Case Report Forms used in clinical trials
• Knowledge or experience developing automated data ingestion pipelines
• Knowledge in transformation from Case Report Form databases to standardized data formats.
• Knowledge or experience developing data validation checks
• SAS programming knowledge
• SQL programming knowledge
• Understanding of current Good Clinical Practices (GCP) VICH, Good Laboratory Practices (GLP) and regulatory guidelines that are applicable to conduct clinical studies.

Desirable Other Attributes:

• Self-directed - can work with little supervision on most tasks
• Goal-oriented, strong desire to achieve and exceed expectations, consistently meets commitments
• Can work effectively under pressure
• Maintains a strategic outlook
• Has desire and ability to anticipate and plan for future change

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.