The Role 

• To support project management in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget
• To comply & adhere to GCP guidelines and regulations as required of this role

Main tasks and responsibilities

• Assist in production and formatting of study documentation e.g. informed consent forms, training materials, file notes, laboratory manuals etc.
• Support set up of vendors.
• Internal risk-based monitoring following first dosing to ensure all study documentation is working effectively.
• Assist with internal data generation such as recruitment and subject status updates, adverse event summaries etc.
• Set up and host Sponsor monitoring visits

• CRA Trial One Training
• Ensure monitoring visit action items are addressed

• Assist Project Managers with close out activities e.g. archiving, reconciliation.
• Manage data query resolution.

• Ongoing clinic query resolution from screening through post discharge following SDV.
• Answer queries during database cleaning.

• Action process improvement initiatives as allocated
• Work with the study team to ensure the Investigator Site File and Trial Master Files are maintained and perform periodic QC of TMF (as per DOC-00433 Trial Master File).
• General support to the Commercial and Project Management groups as needed to win and deliver business
• Support PM Team on Focal Point set up and invoicing.
• Support Database close and lock activities.
• SBIM (meeting minutes).
• Trial One UAT activities.

The Candidate

• Minimum Degree qualification or equivalent
• Relevant work experience in a pharmaceutical company/CRO would be an advantage