Company: Barrington James Clinical
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Great Benefits
You will need to be an experienced Clinical Operations Coordinator with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focused role.
Position: Junior Project Manager
Location: England, United Kingdom
Employment Classification: Full-time
You will need to be an experienced Clinical Operations Coordinator with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focused role. You will be looking to move into the challenge of complex and/or orphan indications in addition to working with Sponsors from Biotech and smaller Pharma Companies or start-up ventures. You will be expected to take responsibility for managing CRA’s and also monitoring clinical studies of new and established pharmaceuticals, ensuring that projects are conducted in accordance with the latest ICH guidelines. You will ensure that clinical staffs (CTAs, Senior CTAs, CRAs and Senior CRAs) gain the necessary skills to perform their respective job responsibilities. You will also ensure that the Project Managers are kept fully informed of all aspects of the project and that Project documentation is obtained and maintained in a timely manner. You are a strong team member and understand the need for effective communication at all levels. You will have a demonstrable record for effective relationship building with sponsors, sites and colleagues, as well as strong management skills. You are confident in presenting studies at site and training Clinical Operations team members. You have high standards for the quality of material presented.
- Graduate, postgraduate, 4-year college degree or equivalent, ideally in a scientific or healthcare
- Five (5) years or more as Clinical Research Associate (CRA) or Project Manager (PM) either in
- Mentoring experience
- Experience of multinational trials.
- IMP trial experience is mandatory. Medical device experience and monitoring of non-IMP trials are not acceptable without recent IMP experience.
- Therapeutic area: Oncology experience is highly recommended. Other TA experience should ideally encompass complex indications and/or rare disease and/or trials in ICU settings.
- Strong knowledge of ICH GCP
- Awareness of global regulatory and pharmacovigilance environments
- Fluent English
- Excellent communication skills, written, oral and presentation
- Excellent organisation and time management skills
- Proactivity and risk management skills
- Excellent computer skill
- Ability to drive
- Deputises for the Director of Clinical Operations, as and when required;
- Acts as line manager for CRAs;
- Acts as mentor for Clinical Operation team members;
- Provides a resource of clinical research experience;
- May co-ordinate, manage and participate in the clinical development of investigational products;
- Assists in the recruitment of clinical operations personnel;
- Assumes an active role in client liaison;
- Ensures clinical trials are monitored such that subjects' rights, safety and well-being are protected and that the clinical trial data are reliable.
- Deputises for the Director of Clinical Operations for all tasks, as required;
- Takes responsibility with the Director of Clinical Operations for resourcing projects appropriately;
- Reviews curricula vitae (CVs) and interviews selected candidates for departmental positions;
- Ensures that each new member of the Clinical Operations department has been inducted and that the induction was successful and productive;
- Ensures that CRAs are appropriately trained in a timely manner and are able to perform their role;
- Is involved in business development and client liaison activities;
- Takes on specified departmental management tasks as required.
- May be involved in clinical trials as a lead CRA or monitoring resource;
- Works as part of project teams to contribute towards efficient management of trials;
- May assume project management responsibility for selected trials;
- Travels as necessary according to project needs;
Interested applicants should forward their CV/Resume to:
Name: William Penticost
Position Title: Recruitment Resourcer
Company Name: Barrington James Ltd
Phone Number: 01293 776644
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