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Study Supervisor Ashland United States,  

Charles River (company)


Posted on : 08 June 2017

Project Description

Company Statement
  • For nearly 70 years, our company  employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. 
  • When you join our family, you will have a significant impact on the health and well-being of people across the globe. 
  • Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform.
  •  In return, we ll help you build a career that you can feel passionate about.


Responsibilities
  • We are seeking an experienced Study Supervisor for our Safety Assessment site.
  • Responsible for managing the technical staff in assigned area. 
  • Responsible for preparing, conducting/orchestrating, and overseeing technical activities in studies of short duration and small size. 
  • Ensure compliance with all applicable regulations and with departmental policies, practices and procedures (e.g., SOPs, protocols).  
  • Responsible for front-line oversight and coordination of all study-related activities.   



About Safety Assessment
  • Our company  is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. 
  • From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. 
  •  Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.



Qualifications
The following are minimum requirements related to the Study Supervisor position.
  •   Prepare, conduct/orchestrate, and oversee technical activities in studies of short duration, generally in small numbers of animals.
  •   Ensure compliance with departmental policies, practices and procedures (e.g., SOPs, protocols).
  •   Provide direct daily supervision and review work of assigned departmental employees to ensure accuracy and to ensure adherence to pertinent departmental policies, practices, and procedures [SOPs, safety procedures and biosafety protocols.] 
  • Schedule and prioritize workload of group members.
  •   Assist in the interview and selection of qualified non-exempt personnel.  
  • Recommend personnel actions, including hiring, promotions and raises.  
  • Partner with Human Resources and departmental management to assist in the handling of disciplinary issues.  
  • Draft appropriate personnel action paperwork.
  •   Identify training and development needs of direct reports. 
  •  Assist in the development, implementation and delivery of departmental training programs; ensure that direct reports receive departmental orientation and necessary on-the-job training.  
  • Oversee maintenance of group training manual and training records.
  •   Monitor performance of direct reports.  Provide regular coaching and counseling.  
  • Assist in preparation and delivery of salary and performance reviews of direct reports.
  •   Manage scheduling, coordination and prioritization of assigned studies.
  •   Coordinate and conduct regular team meetings with assigned staff.
  •   Prepare and review study calendars from draft and final protocols. Ensure all protocol driven activities are accurately scheduled.
  •   Monitor scientific projects and procedures in accordance with the study protocol and applicable SOPs.
  •   Act as liaison between technical staff, internal departments, and study directors for all aspects of assigned studies.
  •   Perform test article dosage calculations and review methodology for appropriate preparation.
  •   Communicate directly with the sponsor or representative concerning study related issues (e.g., shipment information, study specific labels).
  •   Coordinate the shipment of biological samples in support of assigned studies as requested by the study director.
  •   Prepare study notebooks, organize study data and ensure timely review of study data for assigned studies.
  •   Schedule overtime as authorized.  Review and approve time cards.  Coordinate vacation/time off schedules.
  •   Recommend short-range operating objectives, organizational structure of direct reports and staffing requirements.  
  • Assist in the development of a departmental plan for backup and succession of key technical personnel.
  •   May assist in development of departmental budget.
  •   Ensure optimum performance of group function.  Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
  •   Assist in the development, maintenance and communication of departmental systems and SOPs.  
  • Assist in the development and communication of job descriptions for subordinate positions.
  •   Ensure that departmental equipment is maintained in good working condition and that departmental area(s) are maintained in a clean and orderly condition. 
  •   Support the policy of equal employment opportunity through Affirmative action in all personnel actions including but not limited to recruiting, hiring, promotions, training, work assignments, and salary actions, etc..
  •   Perform technical duties as needed.
  •   Perform all other related duties as assigned.



About Us: 
  • For nearly 70 years, our employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies.  
  • When you join our family, you will have a significant impact on the health and well-being of people across the globe.  
  • Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. 
  •  In return, we ll help you build a career that you can feel passionate about. 
  • Our company is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.  
  • Our company also provides a suite of products and services to support our clients  clinical laboratory testing needs and manufacturing activities.  
  • Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. 
  • With over 11,000 employees within 70 facilities in 18 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client s unique challenges.   
  • Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.  
  • We are passionate about our role in improving the quality of people s lives.  
  • Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.  
  • We have proudly supported the development of ~70% of the drugs approved by the FDA in 2016. 



Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet

Locations

Ashland Ohio

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