Data Management Specialist - Animal Health

Job Description

Our Animal Health Research Laboratories team work tirelessly to invent solutions to improve the health and well being of animals. Our state-of-the-art research facilities create an environment of innovation that enable us to create breakthrough science changing the way we approach animal health challenges. 

This position will support veterinary clinical trials. The primary functions can vary depending on the specific role and clients supported. However, some common responsibilities and functions include:

• Write study-specific data management plans and reports.

• Develop and maintain databases to collect and retain clinical data for laboratory challenge and clinical field trials for pharmaceutical and biologic veterinary compounds.

• Collaborate with the Clinical Research Assistant (CRA) on the design of Case Report Forms / Data Capture Forms.

• Assist in establishing data entry screens.

• Program and run edit checks to ensure the integrity and consistency of the data.

• Compare independently entered data and collaborate with the Clinical Research Manager (CRM) to resolve any data entry differences.

• Collaborate with CRM and CRA on data findings and resolve issues through data queries with the Investigator site.

• Evaluate protocol deviations for their impact on data analysis and interpretation.

• Lock final data sets.

• Track and transfer external data to the primary database or warehouse.

• Assist in the development and implementation of processes to enable paperless studies using an Electronic Data Capture system.

• Ensure compliance with Good Clinical Practices (GCP) and maintain patient and owner privacy, as well as protect company intellectual property.

• Collaborate with Medical researchers, Veterinarians, Project Managers, Laboratory Scientists, Clinical Research Managers, Clinical Research Associates, Statisticians, Data Entry Administrators, Medical Writers, Pharmacovigilance, Auditors, Regulatory Affairs Managers, and IT experts to accomplish tasks in a proficient manner, utilizing strong interpersonal skills.

Key Attributes:

Data Management processes. Electronic Data Capture. CDISC CDASH/SDTM. MS Access, SAS FSP, or other database entry screen system. Experience with writing edit checks and performing test patients. Knowledge of Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).

Required Experience:

• Minimum of a Bachelor's degree (or International equivalent) in Data Management, Management Information Systems (MIS), Biological or Clinical Sciences, Statistics, or a related field.

• At least 3 years of experience in the human or animal pharmaceutical industry.

• At least 3 years in a Data Management role or equivalent.

• Expertise in electronic data capture software dedicated to the Data Management process.

• Ability to understand and implement regulatory regulations and company procedures.

• Ability to work independently and efficiently within a project team environment.

• Proficiency in English.

• Proactive, pragmatic, flexible, service-minded, and able to work under time pressure.

• Knowledge of Clinical Research and Clinical Trials.

• Knowledge of Veterinary practices.

• Knowledge of Clinical Monitoring and Auditing.

• Knowledge of FDA/CVM, EMA/CVMP, and VICH Guidelines. Familiarity with FDA/CDER, FDA/CBER, FDA/CDRH, EMA/CHMP, ICH Guidelines is helpful.

• Experience with Regulatory submissions.

• Strong planning skills.

• Strong interpersonal skills, negotiation skills, and teamwork focus.

• Strong verbal and written communication skills.

• Strong presentation skills.

Travel may be required for this position, depending on study activities and other factors.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your sep