POSITION SUMMARY

• The role of the FSP Line manager is to line manage CRAs effectively, ensuring high performance, quality and continuous development, including interviewing, evaluating and selecting CRAs

• To assist sponsor in performing oversight in fulfilling its study management activities and obligations in relation to clinical studies as the primary sponsor of those studies

• Create a culture of process improvement with a focus on streamlining processes adding value to our business and meeting sponsor needs

• In addition, to work according to and comply with relevant ICON/DOCS procedures and processes

JOB FUNCTIONS/RESPONSIBILITIES

• Recruit, manage and lead FSP staff across their respective region

• Ensure FSP staff are adequately trained and adhere to all appropriate SOPs, policies and applicable regulations and guidelines

• Ensure FSP staff achieve expected quality compliance standards with all appropriate SOPs, policies, regulations and guidelines

• Make study/site assignments in conjunction with sponsor

• Ensure FSP staff meet expected study timelines and deliverables

• Support FSP staff to achieve delivery of study objectives

• Provide regular feedback to sponsor management about operations of the FSP staff

• Evaluate performance metrics to identify process improvement areas

• Carry out performance management for staff not meeting appropriate sponsor expectations

Knowledge

• Clinical trial processes and operations

• ICH/GCP Guidelines plus local codes of practice as applicable

Key competencies

• Attention to detail

• Organizational skills

• Relationship management & influencing skills

• Time management & prioritization

• Training skills

• Flexibility

• Written and oral communication skills

• Language skills: English

• Good working knowledge of common software packages

• Presentation skills

• Problem solver

• Team work

Preferred qualifications

• BA/BS/BSc in the sciences or RN

• Experience working as a study manager/Project manager (working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company).

• Previous experience in managing direct reports

• Relevant therapeutic area experience