About this role

Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling
Participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced
Provide expert operational oversight and guidance to support prioritization of activities
Assist in recruiting new staff, including participation in interview process and new hire on boarding
Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP
Work closely within appropriate business unit/region to ensure staff performance on studies
Organize and chair clinical staff meetings at regular intervals
Facilitate and support project and team/country reviews with Clinical Operations staff

Bachelor’s degree in life sciences, nursing degree, or equivalent related experience
extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required
extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements
excellent communication, presentation, interpersonal, and change management skills, both written and spoken
strong time management, technical and organizational skills
knowledge of basic financial concepts as related to forecasting and budgeting
must demonstrate good computer skills and be able to embrace modern technologies
ability to travel as necessary (up to 25%)

company car or car allowance
Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
flexible paid time off (PTO) and sick time

Manager, Clinical Operations – CRA Line Management, CRA Monitoring Experience Required

Key skills