Clinical Trial Manager
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Job Description
Global Clinical Trial Manager managing clinical trials for a single sponsor at a leading clinical research organization. Developing protocols and overseeing trial activities with a focus on compliance and quality.
Responsibilities:
- Manage external vendors and contract research organizations
- Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
- Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
- Assist with protocol development and study report completion
- Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
- Provide guidance, direction, and management to CRAs
- Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
- Coordinate study supplies
- Negotiate contracts with vendors of clinical trial services
Requirements:
- Bachelor’s, nursing degree or equivalent required, science preferred
- 5 or more years of industry experience in global clinical studies (Pharmaceutical, Biotech or CRO)
- Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
- Proven experience of clinical trial management
- Experience in CNS and / or oncology is preferred
- Proven management/leadership of people in a matrixed environment
- Management of global clinical trials
- Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
- Demonstrated ability to work independently and in a team environment
- Travel required. Must be willing to travel 15-25%, including international travel
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
- Excellent oral and written communication skills and strong organisational abilities
Benefits:
- Professional development opportunities
- Open and friendly work environment
- Opportunities to develop long-term careers
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