Clinical Study Specialist – Oncology experience
Location: London or Ireland based - 3 days on site.
Contract: 12 months
Rate: Negotiable daily rate
Cpl Life Sciences have partnered with a global, well respected Biotechnology company to bring on board a Clinical Study Specialist. The role will provide technical and administrative support to the clinical study team(s) responsible for clinical trial execution. You may be assigned to support the execution of one or more studies across a program and receive assignments from the Clinical Study Lead or Clinical Study Associate Manager. Along with supporting internally sourced studies and studies out-sourced to Clinical Research Organisations (CROs).
Requirements for the role are:
• BSc degree or Strong experience in Clinical Operations or trial management
• Strong attention to detail for the ability to track information and deliver on assigned study activities
• Demonstrate strong communication and interpersonal skills; ability to form relationships internally and externally
• Ability to proactively assess information and investigate impact on clinical trials
Key Responsibilities are but not limited to:
• Deliver reports and metrics to the clinical study lead
• Schedule and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
• Collates data for assessments such as feasibility and site selection and reviews site usability database
• Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
• Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
• Collates materials for training and investigator meetings
• Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
• Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
• Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
If this roles sounds of interest please apply direct, or send your CV to [email protected]