Associate EDC Data Manager

Zoetis Zaventem is currently looking for an Associate EDC Data Manager.

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 eClinical electronic data capture system (EDC)

• Assist to organize electronic data for global government regulatory submissions and assist with responding to internal/external audits.

• Provide study-specific database and setup within an EDC system

• May 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

• May help with the creation of data ingestion programs and transformation tasks, including automating ingestion pipelines for use across clinical studies

• Troubleshoot data and EDC issues with customers though 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:

• Some evening and/or weekend system support may be required

• Travel: approximately 5 – 10% on an annual basis.(Variable, depending upon project status.)

• Flexibility to work with global team members (i.e. North America, Asia, Australia, ect)     

QUALIFICATIONS

Educational Background:

Minimum:  Bachelor's degree  

Desirable:  Master’s degree

Desired degree in the following or related 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

• 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.

• 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

• Knowledge with general-purpose programming language (e.g., Python, JavaScript, C#).

• Knowledge in designing databases that correspond to Case Report Forms used in clinical trials

• Knowledge or experience in developing automated data ingestion pipelines

• Knowledge or experience developing data validation checks

• 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