What are the responsibilities and job description for the Principal Specialist: Study Management position at Clinglobal Group?
Our Story
Clinvet South Dakota is a global veterinary contract research organization (CRO) that conducts preclinical and clinical trials to evaluate the safety, metabolism, and efficacy of animal health products. Clinvet SD is part of the Clinglobal group, which focuses on animal health and consists of various CROs dedicated to supporting innovation and product development.
Departmental Objective
To efficiently conduct research in compliance with the Quality Management System, the Animal Care and Use Program, along with project budgets and timelines. Our goal is to expand and enhance site research activities through innovation, development, and customer focus.
Primary Job Purpose
Responsibilities include monitoring animal health status, coordinating study events, and reviewing and approving study documentation throughout the study. The role also entails group leader responsibilities, assisting other study investigators, and providing support to staff as required.
Job-Specific Duties and Responsibilities
- Oversee the protocol development, technical conduct, and organizational aspects (start to finish) of GCP studies.
- Prepare, review, and approve clinical study protocols and data capture forms (DCFs) for sponsors.
- Prepare study-specific Clinvet IACUC protocols and IBC assessments.
- Organize and coordinate pre-study meetings.
- Provide technical directions and guidance to all study participants regarding their responsibilities and accountabilities.
- Participate in key clinical activities, such as pre-study room/pen walkthroughs, arrival infections, IVP administration, challenges, and necropsies.
- Deliver training on study protocols, DCFs, critical diseases, biosafety, biosecurity, and zoonotic diseases as required.
- Ensure effective communication with the sponsor, Quality Assurance (QA), and other test sites/subcontractors during the study.
- Collaborate with the RTI Laboratory to ensure timely submission of quality clinical samples and timely completion of laboratory tests and inventory retention per study protocol.
- Assist in hosting regulatory and sponsor inspections/audits and address any regulatory inspection and QA audit findings, including action plans and corrections.
- Prepare, review, and update clinical Standard Operating Procedures (SOPs).
- Establish a professional network to support business development.
Qualifications, Training, and Experience Requirements
- PhD or MSc in life sciences; or
- Licensed Doctor of Veterinary Medicine (DVM); or
- A post-secondary university degree in life sciences (e.g., BSc) with at least 5 years of hands-on clinical animal research experience.
Benefits
Salary is commensurate with experience and qualifications.
As a full-time employee, you will be eligible for Clinvet's insurance offerings, which include health, dental, vision, short-term and long-term disability, and life insurance.
You will also be able to participate in the Clinvet 401(k) retirement plan, with the company matching up to 4% of your pay after one year of employment.
This position provides paid time off (PTO).
Clinvet SD provides equal employment opportunities to all employees and applicants for employment. We prohibit discrimination and harassment of any kind based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.