EARLY PHASE STUDY MANAGER
Closing date for applications: 15 April 2025
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.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
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.
BENEFITS:
Health Insurance
Free onsite parking
25 days annual leave (increasing in increments to 30 days after 6 years' service)
Your birthday off work
MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Please email maccareers@macplc.com 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.
Salary: Competitive + Negotiable £ Apply Now
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