I am working with a fantastic fast-growing ophthalmological biotech working on developing an innovative new product that are actively seeking to hire three Senior CRA / Associate Clinical Project Managers to join their Clinical Operations team on a 12-month contract basis. This is an excellent role for an experienced CRA or Associate Clinical Project Manager who has come from a clinical background with a strong emphasis on site management.
Key Responsibilities include:
- Working with the Clinical Operations study team, responsible for clinical operational oversight and execution of all assigned studies.
- Contribute to operational aspects of the design, content, and preparation of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets
- Monitoring of study deliverables
- Performing protocol-related site management activities
- Participating in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans
- Supporting vendor relationships
- Using relevant reports, identify the progress of CRF data collection and query resolution
- Bachelor of Science Degree in Life sciences or Nursing background or equivalent
- 2 years’ experience in the pharmaceutical or biotech industry (including CRO) working in the management of clinical trials
- Ophthalmology experience would be ideal, oncology/gene therapy experience highly beneficial as well
- A team player with the flexibility to work over multiple projects if required
- Excellent communication skills (written and oral)
- Able to proficiently represent the Clinical Operations Dept and the overall business across all functions as well as external parties and KOLs
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