Associate Specialist, Data Manager

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. 

The primary functions of this position are:

• To assist in writing study specific data management plans

• To assist in developing and maintaining databases to collect and retain clinical data for laboratory challenge and clinical field trials for pharmaceutical and biologic veterinary compounds by following good Data Management practices

• To collaborate with Clinical Research Assistant (CRA) on Case Report Forms / Data Capture Forms conception

• To establish data entry screens

• To program and run edit check and test integrity and consistency of the data

• To compare the two independently entered data (“confrontation”) and collaborate with Clinical Research Manager (CRM) to resolve  data entry differences

• To collaborate with CRM and CRA on data findings and resolve via data queries with the Investigator site

• To evaluate protocol deviations for effect on data analysis and interpretation

• Lock final data sets

• To track and transfer external data to primary database or warehouse

• To assist with studies being conducted paperless by using a Electronic Data Capture system

• To follow Good Clinical Practices (GCP), display unquestionable ethics, maintain patient and owner privacy, and protect confidentiality of company intellectual property

• To 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 professionally accomplish the above stated tasks in a proficient manner, exercising strong interpersonal skills

Education and Experience:

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

• Experience with clinical or research data is preferred but is not required
   

Qualifications:

• Expertise on databases, especially with software dedicated to Data Management process

• Ability to understand and implement regulatory regulations and company procedures

• Ability to work independently and efficiently, in a project team environment

• Must be able to speak and write English.

• Proactive, pragmatic, flexible, service minded and able to work under (time) pressure

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please