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 electronic data capture (EDC) and data management (DM) teams. Candidate will assist and/or lead electronic data capture system and data management tasks associated with clinical studies to support global VMRD Projects.
* Flexible Work Location will be considered for candidates with significant experience in EDC and DM
Specific responsibilities may include, but are not limited to:
Electronic Data Capture:
- Assist and manage the building and coordinating of Zoetis' clinical studies in an eClinical. electronic data capture system (EDC)
- Collaborate with multiple internal partner groups to plan, coordinate, conduct, analyze and report studies within an EDC system
- Conduct training of Investigators and external/internal study personnel
- Serve as the principal communication link between the EDC team, other VMRD groups, and external partners
- Assist to organize electronic data for government regulatory submissions and respond to internal/external audits.
- Provide EDC related project updates to clinical teams and sub-teams
- Administrative support activities including but not limited to:
- Managing multiple Outlook Calendars
- Maintaining internal EDC tracking system
- Performing initiation and archival of EDC studies
- Managing and maintaining the eClinical solution's user access
- DM assistance to study team members and biometricians to review study protocols and develop data capture and storage specifications for study data
- Support and training for study teams in the use of DM systems and process-specific requests involving study data maintained by these systems such as data imports, data corrections, new study number requests, and data pack unlocks
- Management of the library of data forms that are used to capture study data
- Provide study-specific database setup
- Program data ingestion and transformation tasks
- Troubleshoot data issues with customers though ad-hoc investigations
- Support VMRD Data Management processes by developing and supporting automated data ingestion pipelines that can be used across clinical studies.
- Some evening and/or weekend system support required
- Travel: approximately 5 - 10% on an annual basis.(Variable, depending upon project status.)
Minimum: Bachelor's degree
Desirable: Master's degree
Desired degree in the following areas:
Work Experience/Skills: Minimum:
- Information Management
- Computer Science
- Data Science and/or Data Analytics
- Animal Science
- Two years' minimum experience with eClinical Solutions and electronic data management/capture systems in a clinical or research environment.
- Experience in building and configuring studies within an electronic data capture platform or eClinical software
- Two or more years of experience working with data in a regulated environment
- Experience designing databases that correspond to forms used for data collection
- 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 Other Attributes:
- Two or more years in Pharmaceutical R&D (Human Health or Animal Health) in a clinical data management and/or electronic data capture specialty
- Education and clinical experience in the field of veterinary technology and/or livestock production systems.
- Previous experience in the preparation of electronic data for regulatory submissions.
- Experience designing databases that correspond to Case Report Forms used in clinical trials
- Experience developing automated data ingestion pipelines
- Proven ability with SAS and/or a SQL dialect (SQL Server, MySQL, PostgreSQL, SQLite)
- Experience developing data validation checks
- Advanced SAS programming knowledge
- Understanding of current Good Clinical Practices (GCP) VICH, Good Laboratory Practices (GLP) and regulatory guidelines that are applicable to conduct clinical studies.
- 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
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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.
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