Manage external vendors and contract research organisations.
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.
Review Informed Consent Forms, CRFs, and study related materials.
Plan and participate in investigator meetings.
Assist and support data query process.
Assure regulatory compliance of investigational sites with sponsor’s SOPs and FDA and ICH guidelines.
Ensures trial master file is current and maintained.

Bachelor’s, nursing degree or equivalent required, science preferred
5 or more years of industry experience in 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.

Clinical Trial Manager – FSP

Key skills