Principal Specialist: Study Management

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The Principal Specialist:  Study Management is responsible for monitoring animal health status, performing and coordinating study events, and reviewing and approving study documentation as necessary throughout the study.  This position will have group leader responsibilities, assist other study investigators, and support staff as required 

Job Specific Duties and Responsibilities 

• Overall responsibility for the protocol development, technical conduct, and organizational aspects (start – finish) of GCP studies 
• Preparing, reviewing and approval of Sponsor clinical study protocols and data capture forms (DCFs). 
• Preparing study specific Clinvet IACUC protocols and IBC assessment 
• Organizing/coordinating pre-study meetings  
• Providing technical directions and guidance to each study participants in responsibilities and accountabilities 
• Participating key clinical activities (such as pre-study room/pen walk-through, arrival infections, IVP administration, challenge, necropsy) 
• Providing study protocol and DFC training, critical disease training, Biosafety-Biosecurity-zoonotic disease biosecurity trainings as required 
• Ensuring effective communication with the Sponsor, QA, and other test sites/sub‑contractors during the conduct of the study 
• Collaborating with RTI Laboratory to ensure timely submission of quality clinical samples and timely completion of laboratory tests and inventory of retention samples per study protocol 
• Collaborating with ClinData team to ensure timely delivery of DCFs for data Entry and analysis per study protocol 
• Assisting/hosting regulatory and sponsor inspections/audit and addressing regulatory inspection and QA audit findings including plan of actions/corrections 

• Prepare/review/update clinical SOPs  
• Establishing professional network to support business development 

Qualification, Training and Experience Requirements 

• PhD or MSc in life sciences or 
• Licensed Doctor of Veterinary Medicine (DVM) or 
• Post-secondary university degree in life sciences (e.g., BSc) and at least 5 years hands-on clinical animal research experience 

 Specific Job Knowledge, Skills, and Behaviors: General Competencies 

• Knowledge and Skill – A consistent demonstration and application of required levels of job competency and skill. Continuous development in line with job requirements 
• Service and Customer Focus - Using skills and expertise to effectively deliver high quality service, helping others to achieve their goals 
• Communication - Communicating clearly and concisely (verbal, non-verbal and written) in understandable and relevant manner to all stakeholders to ensure productive working relationships 
• Teamwork - Actively participate and encourage team work to achieve shared outcomes and aims 
• Delivering quality work within the required timelines - Contribute to high quality service delivery with attention to detail and required specifications consistent with the company’s values and strategies within set timelines 

 Physical Requirements 

• While performing the responsibilities of the job, the employee is required to 

• wear the required protective clothing and equipment issued for the specific position and/or task 
• communicate effectively by talking, listening, reading, and writing 

• At all times, be sober and clear of influence of any substances which may affect the ability of the user, safety of animals and other staff members, and work quality in any manner  

• Comply with any pertinent local legislative requirements and any additional physical requirements as determined by the Occupational Risk Evaluation Profile for the position 

  Work Environment 

• The employee is required to:  

• work in an office/laboratory/outdoor environment  
• interact with and handle animals  
• be available for work during normal work hours as well as after-hours according to pre-arranged departmental schedules that may require evening, weekend, and public holiday work 

 Compliance Requirements 

• Perform duties according to quality guidelines (e.g., GCP/GLP as relevant), Standard Operating Procedures (SOPs), Work Instructions (WIs), and in line with the relevant study protocols or study plans 
• Perform duties in compliance with relevant legislative and regulatory requirements  
• Observe occupational health and safety regulations and comply with Personal Protective Equipment (PPE) requirements as required for the position   
• Identify, record and report incidents, maintenance faults and issues impacting animal welfare, biosafety, and study conduct  
• Work outcomes and behavior should be in accordance with company and departmental standards as well as values and ethics. Continuous evaluation and/or assessment may be used to determine compliance thereto  
• Meet continuous professional development requirements, if relevant, inclusive of registration and points requirements with the relevant council, institutions, etcetera  
• Continuous training, development and supervision are mandatory to comply with company policies, procedures, guidelines, and job role standards 

Clinvet SD provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability,  genetic information,  service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Equal employment opportunity applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.

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