Clinical Lab Manager

We are still growing strong.

For over 25 years, Novum Pharmaceutical Research Services has been a world leader in the conduct of clinical trials and equivalency studies for the generic, pharmaceutical, and biotechnology industries.

Last year alone the FDA approved over 40 products for marketing where Novum had designed, conducted and reported the studies in the marketing application.  We have completed over 2,000 studies with over 36,000 participants for more than 200 pharmaceutical companies. 

Medical Research Clinic Manager

Position Summary

Day to day management of staff and operations related to clinic biological specimen collection, processing and shipping activities for clinical research investigations. Including ensuring compliance according to protocols, Standard Operating Procedures (SOP’s), Good Clinical Practices (GCP’s), FDA regulations and other regulatory standards.

Responsibilities

·        Hire, train and manage sample collection and processing staff necessary for work on

         research studies (e.g. phlebotomists and technical staff).

·        Review protocols, determine staffing needs and work with other clinic management  to

         ensure that studies are staffed appropriately.

·        Ensure that all biological specimens are collected, processed, stored and shipped

         according to the protocol and laboratory instructions.

·        Organize and conduct initiation meetings with clinic management and technical staff to

         ensure that staff are trained on each protocol.

·        Mentor and train supervisory technical staff to ensure that they are providing clear

         assignments and proper training to all laboratory staff scheduled to work on studies.

·        Comply with safety regulations established in the SOP’s and required by OSHA, FAA etc.

·        Quality Control of documentation of study activities.

·        Review protocols to ensure that supplies (blood draw tubes, dry ice, etc.) are ordered for

         each study.

·        Ensure that laboratory areas are fully prepared and stocked for all studies. Ensure that all

         equipment is working, programmed and preventative maintenance is current according

         to the SOP’s.

·        Interact and communicate with external analytical laboratories to ensure sample

         handling processes are appropriately documented and accurate prior to the start of the

         study.

·        Coordinate and manage sample packing and shipment/delivery to external analytical

         laboratories.

At least 2 years management/supervisory experience in a medical, research, lab or similar setting.  Able to prioritize projects and work schedules to ensure timely completion of projects.  Experience working with and managing full and part time hourly staff.

A flexible work schedule is required.  Must be able to work 10-12 hours shifts, evenings and regular weekends as needed.

Would you like to work for a company with small company values where everyone works as an integral part of the team to get the job done?  At Novum, our mission is to ensure excellence.  We have a commitment to an ongoing learning process and professional development.  Our employees dedication to quality makes us what we are today.  Because of that dedication, work/ life balance is important to us. 

We take care of our employees.  Novum offers a very generous benefit program including: Health, dental, vision, dependant care and health flexible spending account, vacation, holiday and sick pay, short and long term disability, life insurance,  tuition assistance and 401(k). 

Please forward your cover letter, resume and salary requirements.  EOE

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