- To work with an inventor of award-winning medical technology
- To be part of a business going through rapid expansion into the global market
About Our Client
PageGroup Scotland are delighted to be supporting emblation - an award-winning medical technology company, revolutionising the way microwave energy is used in healthcare.
Their aim is to improve on traditional treatments, using the unique advantages microwaves deliver - accurate, repeatable procedures, and better clinical outcomes.
Their technology is revolutionising the treatment of HPV infections globally, and is widely used in Dermatology, Podiatry and Oncology, with a number of disruptive applications under development in the fields of Cardiology and Gynaecology.
The company was started in 2007 by joint co-founders (current Chief Executive Officer and Chief Technology Officer) and inventors behind the technology. They form part of the highly experienced management team with over 50 years of experience in this field.
You can now find emblation's medical devices in 1000s of clinics and hospitals across the UK, the US, Canada, and Australia. They are just at the start of a journey and you will be joining the emblation team at a key phase in their growth.
Having recently secured additional investment into the business to fund the next stages of the company's development, underpinned by 3 primary goals:
* Expansion into new treatment areas
* Development of new markets and a wider global presence
* The addition of new talent to our Scottish Headquarters to bring the skills and
experience needed to support our plans for growth.
* Develops, writes and/ or reviews study related documents including (but not limited to) the study protocol, informed consent form (ICF) templates, Manuals, Source Documents, Case Report Forms (CRFs), Monitoring Plans etc
* Responsible for preparing documentation for Ethics and Regulatory Submissions.
* Assists in the preparation of Investigator meetings
* Responsible for conducting site qualification visits, initiation visits, regular monitoring visits and closing out sites, as needed.
* Responsible for setting up and maintaining the Trial Master File (TMF): collating, printing and filing all essential clinical trial documentation.
* Manages, monitors and tracks shipments of clinical trial supplies and material to Investigator Sites and Contractors.
* Provision of administrative and logistical support to the project team, contractors and investigational site staff in the preparation, initiation, progression and close-out of a clinical trial.
* Complies with company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and regulatory requirements.
* Tracks progress on clinical trials, including safety and provides regular updates to the Clinical Trials Manager.
* Communicates effectively and regularly with the project team, contractors and site staff.
* Coordinates meetings and writes minutes of meetings.
* Participates in internal and external audits and inspections.
* Reviews and updates Standard Operating Procedures.
* Attention to detail.
* Meets aggressive timelines.
* Adapts to change effectively and is flexible in their approach to work
The Successful Applicant
You will be an energetic, passionate, self-starter with a positive disposition and someone who will relish a working environment which is focused on growth and the changes needed to deliver it. Extensive travel including the UK, EU, US and Canada will be required.
This position will also suit a Candidate with a Masters degree in Life Sciences or similar with a willingness and determination to train and develop further within this sector.
* Previous experience as a Clinical Research Associate in the medical device
or pharmaceutical industry
* Bachelor's degree, preference to candidates with a scientific background (MSc or
similar) or nursing qualification.
* Excellent computer and word processing skills in Word, Excel and Powerpoint.
* Excellent communication skills, organisation skills and flexibility
* Detail orientated
* Works effectively within a team and independently
* Ability to plan and multi-task
What's on Offer
Salary £25K - £38K NEG/DOE, Benefits
Clear Pathway for development and progression
Opportunity to be part of a business with rapid expansion across the Globe.