Novartis Animal Health is a world leader in the development of animal health products that meet the needs of pet owners, farmers and veterinarians. Our products are brought to life by diverse, talented, high-performing employees who are committed to saving, prolonging and improving animal lives.

At Novartis Animal Health, our focus is clear, our purpose defined.

Think What’s Possible.

Description:

Monitors clinical and laboratory studies and ensures compliance with regulatory requirements and study protocols. Independently monitors specific studies (GCP and GLP studies, field studies and laboratory studies) by contacting investigators, scheduling study site visits, auditing study records and preparing Monitor reports to ensure compliance with study protocols and regulatory (EPA and FDA) requirements. Participates on research study development teams, global project teams and various monitoring teams by advising on clinical procedures, providing reciprocal training and pursuing continuing education to maintain a competitive position. Plays a key role in communicating between Product Development Managers and third party contract facilities (such as clinics and laboratories) regarding details of study conduct and process compliance. Develops study protocols for both GCP and GLP studies under the supervision and guidance of Development Managers. Assists in supporting test article preparation, delivery, and retrieval to/from study sites. Remains current on regulations concerning animal health drug development. Assists in the preparation of reports by verifying accuracy and resolving compliance questions; ensure protocol and protocol amendments have been correctly implemented. Ensures protocol deviations are identified, recorded and communicated. Ensures randomization procedures are followed and designated personnel remain blind to the treatment assignments as specified by study protocols. Participates in the submission of data to Regulatory Affairs. Chair team meetings when needed, provide input to team in order to improve potential study problems, maintain communication between team and co-workers. Recruit investigators and initiate studies independently. Have experience and knowledge in clinical trial initiation, completion and submission. Performs other related duties and assignments as required.

Qualifications:

Master of Science degree in a relevant field or Bachelor of Science degree in a relevant field and at least 2 year of relevant experience or other degree plus at least four years of relevant experience. Working knowledge of Good Clinical Practices/Good Laboratory practices/(GCP/GLP's). Minimum 2-3 years experience with clinical drug research in an academic/industrial life science arena. Good knowledge of PC package tools, including but not limited to: Word-processing (Word), Spreadsheets (Excel), Database (Access), Presentations (Powerpoint) and electronic data capture systems (Teleforms). Knowledge of medical terminology. Ability to effectively communicate verbally and in writing. Strong leadership skills. Ability to effectively work with teams. Strong sales and customer service skills. Strong analytical skills. Ability to set priorities and manage multiple tasks. Ability to travel extensively, and manage various scheduling requirements.

Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.

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