- MAC - FULL TIME
MEDICAL MONITOR
Closing date for applications: 24 May 2024
MAC Clinical Research are looking for an experienced Medical Monitor to join their growing CRO team! This is an exciting opportunity to work on projects with sponsor companies in our Medical Monitoring Department.
Qualifications
Medical doctor degree
2 years’ experience in pharmaceutical industry as Medical Monitor (essential)
Minimum of 2 years’ prior and wide experience as a practicing medical monitor in pharmaceutical industry
Minimum 5 years’ experience working in clinical development/ clinical trials in pharma or CRO, preferably with experience in neuroscience and internal medicine.
Post graduate qualification or experience in industry / drug development/ clinical trials in Neuroscience (desirable)
Skills
Deep knowledge of GCP including good understanding of regulatory requirements
Analytical and critical thinking skills.
Effective communication and interpersonal skills
Ability to work in a cross-functional team environment.
Experience in protocol development and clinical trial management
Full working proficiency in English
Proficiency with MS Office applications
Communication, presentation and analytical skills
Problem-solving, team and detail-oriented
Responsibilities
Managing day to day study related medical issues
Conducting study or disease-specific training to study team as required.
Draft initial Medical Monitoring Plan with sponsor and revise as required
Provide medical oversight on study related issues including eligibility review (as required), medical questions from site/project team (as required), review of protocol deviations from site/project team, and Medical Monitoring Safety Report (as required)
Review Safety Management Plan, read and comment as necessary, review of any safety reports (i.e. SAE Reports, SUSARs, pregnancy reports) and associated documents and unblinding for medical emergencies as required
Review, read and provide comments/revisions to statistical analysis plan (SAP) as required
Review of Safety Data, granted remote, read-only access to the study EDC system and lab portal to allow for real time observation of the data
Review of Draft / Final: Clinical Study Report (CSR) and provide comments as indicated
Out of Hours medical coverage (24/7 coverage for urgent safety issues)
To maintain professional qualifications required for the role, including continuous personal development
To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out.
A medical expert providing professional advice to sponsors and advice to the medical team at MAC.
BENEFITS:
Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
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
