Early Phase Study Manager

We are seeking to appoint an Early Phase Study Manager 1 to join our Early Phase Unit team in Manchester and make a positive impact in a growing and progressive CRO. 

The focus of this role is to:

• Objectively assess and apply project management knowledge to ensure that the clinical phase of the project is completed in accordance with the scope, quality, timelines and cost of the contract. 
• To effectively coordinate and manage 1-2 concurrent actively recruiting clinical research trials and manage the set-up and close-out of additional trials. 

• RGN / RMN or 
• BSc Nursing / Biomedical or 
• BSc in a scientific field / relevant clinical trial experience. 
• In lieu of Bachelor’s degree a minimum of 5 years clinical research experience. 
• 1-year minimum experience within the field of clinical trials. 

RESPONSIBILITIES:

• Review the study protocol and ensure review within the wider clinical team. 
• Assist in preparation and completion of the risk management plan. 
• Creation, maintenance and ongoing QC of hard copy of the Investigator Site File. 
• Host SIV and organise Study Specific Protocol Training 
• Provide or organise training for any study specific equipment or specialist techniques for the wider clinical team. 
• Maintain an awareness of recruitment issues and deadlines and promote and assist in recruitment activities where required. 
• Maintain an awareness of and effectively communicate subject/patient status throughout the course of the study. 
• Coordinate, support and oversee clinical activity alongside the Lead Study Nurse and Clinical Team. 
• Ensure dose escalation data is produced in accordance with the regulations and SOPs and ensure QC of the Interim Safety Report is performed. 
• Communicate updates to appropriate clinical departments e.g. PM and client (where appropriate) – recruitment and study progress, sample shipment. 
• Participate in project calls and Sponsor TC where appropriate. 
• Organise regular clinical team meetings, pre-study and during study active phase to ensure multi-disciplinary teams are kept fully up to date and study runs smoothly. 
• Host monitoring visits, be available to resolve monitoring queries and ensure all documents are available for the monitors. 
• Host close-out visit 
• Prepare the documents for archiving in a timely manner. 
•  

• Health Insurance
• Free onsite parking
• 25 days annual leave (increasing in increments to 30 days after 6 years' service)
• Your birthday off work

Please email [email protected] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.