
CTA Line Manager
- Cambridgeshire
- Permanent
- Full-time
- To assist our client in performing oversight in fulfilling its site 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 company needs
- Interact with strategic partners (KOLs, Investigators and Site Staff) as necessary for execution of clinical trials
- Ensure FSP staff achieve expected quality compliance standards with all appropriate SOPs, policies, regulations and guidelines,
- Support FSP staff to achieve delivery of study objectives
- Ensures that CTAs are qualified and trained, both in clinical studies execution and in policies and procedures, to provide data that meets quality requirements
- Provide leadership in the continuous improvement in CTA performance and monitoring processes
- Conduct resource planning and metrics review
- Conduct staff regular performance assessments and personal/career discussions with direct reports
- Responsible for providing regular updates to Senior Management and adhering to metrics
- Supervise translation process
- Supervise eTMF process
- Clinical trial processes and operations
- ICH/GCP Guidelines plus local codes of practice as applicable
- 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
- Teamwork
- BA/BS/BSc in the life sciences or RN
- Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
- Full-time 1-year contract for maternity leave cover
- Office-based in the Cambridge area (UK/England)
- Salary according to level of skills and experience