Study Monitor - Bristol-Myers Squibb

Study Monitor( 1700820)
Description

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

 

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

 

Job Responsibilities

• Main focus of role will be to act as Study Monitor for reproductive toxicology studies conducted at a Contract Research Organization (CRO).

• Ensure nonclinical studies are conducted in compliance with approved study protocols, Standard Operating Procedures (SOPs), and, if appropriate, Good Laboratory Practice (GLP) regulations. Ensure compliance with all company/departmental policies, as well as other federal, state and corporate policies and guidelines.

• Create an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivity.

• Continuously evaluate and apply new scientific methodology in order to maintain scientific or technical excellence, to increase productivity, to meet our research and drug registration needs.

• As Study Monitor for studies that conducted at CROs:

  - Provide study design forms to CRO Study Director and ensure that final protocols are aligned with the approved study designs.

  - Coordinate review of protocols, reports, and amendments thereof with key stakeholders within BMS.

  - Periodically travel to CROs to ensure studies are being conducted in compliance with protocols, SOPs, and regulatory requirements. This will include observing critical study activities (e.g. first dose administration), reviewing training records of study staff, and reviewing study data.

  - Oversee cesarean sections and fetal morphological evaluations.  Confirm malformations as appropriate.

  - Maintain regular contact with CRO Study Director to ensure up-to-date knowledge of study status and findings.

  - Keep DART management and DSE project representative apprised of study findings and results.

  - Work with CRO Study Director to evaluate and interpret test results and ensure written summaries and reports are prepared in accordance with established timelines and which meet regulatory requirements.

  - Communicate potential issues related to CRO performance to DSE management

• Collaborate closely with internal and external support groups, including but not limited to staff in DSE Project Representatives, Pathology staff, analytical and bioanalytical laboratory staff, and Veterinary Sciences staff colleagues.

• Ensure studies are conducted in compliance with current animal welfare standards.

• Embrace/demonstrate BMS Core Behaviors.

• Perform other tasks/procedures as assigned by line management.

 

Qualifications 

• BS, MS, or PhD in toxicology or related discipline with at least 3 years of experience in the conduct of toxicology studies required for product registration. Position level will be commensurate with experience/qualifications.

• Expertise in fetal morphological evaluation.  Preferably certification from International Register of Fetal Morphologists.

• Knowledge of the general principles of reproductive toxicology, animal and human biology and reproductive physiology, especially clinical and functional changes associated with toxicity.

• Effective written and oral communication skills, especially as they pertain to writing clear and accurate reproductive toxicology reports

• Ability to effectively communicate with co-workers at all levels and to work independently.

• Thorough knowledge of Standard Operating Procedures and Good Laboratory Practice Procedures.

• Knowledge of laboratory animal welfare standards (USDA, AALAC, etc.)

• Role will involve 30-40% travel (US and Canada)

  

Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability 
Job Function : Tox
Primary Location : NA-US-NJ-New Brunswick
Organization : R&D - Discovery - Drug Safety Evaluation (DSE)
Study Monitor

 

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