Clinical and Scientific - Clinical Operations Lead III

Company: Artech LLC
Location: Austin
Posted on: January 27, 2023

Job Description:

I'm a recruiting consultant with Artech and I'm hoping I can help you find the perfect next opportunity for your career goals. You very well could be happy in your present role but might be looking for a more challenging project or maybe you want to explore opportunities outside your comfort zone. I am currently recruiting for a Clinical Operations Lead III one of the largest pharmaceutical companies in the US. Below are the specs for the role:

Job Title: Clinical Operations Lead III
Location: Remote
Duration: 24 months+ (High possibility of extension!)
Job Description:
The Clinical Operations Lead will support the implementation and execution of Client s clinical trials by performing specific tasks at country, regional and site level. This person will ensure trial conduct is efficient, with seamless execution, achievement of timelines and study results with quality, and full compliance with international guidelines, local regulations and corporate policies and procedures.
Major Responsibilities:
" Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of 2-3 clinical trials of low to medium complexity in support of one or more projects.
" Provide operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, and other documents as required
" Develop Protocol Monitoring Plan (PMP)
" Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, achievements, and status of CSM activities
" Prepare, coordinate, deliver, and track protocol specific training
" Initiate Investigational Product shipment requests, resupply and coordinate reclamation of supplies from sites for assigned trial(s)
" Create and maintain user account worksheets for provisioning all site personnel for assigned trials into required systems (e.g. EDC, IRT, training portals)
" Proactively identify potential/actual issues and risks, bring up to management as appropriate, and contribute to mitigation
Competency Profile
" Customer Focus
" Action Oriented
" Collaborates
" Communicates Effectively
" Plans & Aligns
Preferred Qualifications:
" Bachelor's degree in life science; Medical, pharmaceutical, biology, chemistry degree preferred.
" The ability to fluently read, write, understand, and communicate in English
" Clinical trial management experience, field clinical monitoring, or site management (e.g., study coordinator) experience
" 5 Years of Relevant Experience Education

Artech has been an employer-of-choice for 27 years, proudly serving over 80 Fortune 500 companies. We have dedicated professionals that will help you with your next career move. Our recruiters will listen carefully to your career goals and then match your skills and aspirations to various open roles. There is nothing we are more passionate about than finding candidates a rewarding job that makes them happy. Artech is an EEO Employer.

Keywords: Artech LLC, Austin , Clinical and Scientific - Clinical Operations Lead III, Healthcare , Austin, Texas