(Archived) Senior Associate – US Clinical Operations

JOB TITLE:

Senior Associate I/II

US Clinical Operations

Global Therapeutics

Veterinary Medicine Research & Development (VMRD)

Kalamazoo MI

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 US Clinical Operations, the candidate will be a member of the electronic data capture (EDC) team and will assist and/or lead electronic data capture system tasks associated with clinical studies to support global VMRD Projects.

Responsibilities may include, but are not limited to:

• Assist and manage the building and coordinating of Zoetis’ clinical studies in an 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

• Some evening and/or weekend system support required
• Travel: approximately 10 – 30% on an annual basis.(Variable, depending upon project status.)

EDUCATION AND EXPERIENCE:

Educational Background:

Minimum: Bachelor's degree

Desirable: Master’s degree

Work Experience/Skills:

Minimum:

• Two years’ minimum experience with eClinical Solutions and electronic data management/capture systems in a clinical environment.
• Experience in building and configuring studies in an electronic data capture platform
• Pharmaceutical industry experience as a research or clinical study coordinator/monitor with veterinary clinics and/or research facilities
• Ability to work both as a member of a team and independently in a self-directed and self-motivated manner.
• 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:

• Understanding of current GCP VICH and regulatory guidelines that are applicable to conduct clinical studies .
• 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.