Clinical Trials Manager
Micrima are recruiting for a Clinical Research Manager to oversee the day-to-day management of their multicentre clinical trials of the MARIA™ system. The Clinical Research Manager will work closely with other members of the team and the hospital staff at the individual sites. The responsibilities of the post include the efficient delivery of trials, ensuring timely accrual and the collection of high quality data from multiple participating centres, as well as driving development of the company’s training materials for early customers.
Responsibilities may include some or all of the following in collaboration with other members of the team:
- Prepare trial documentation e.g. protocols, trial guidance notes, case report forms (CRFs), and patient information
- Prepare regulatory, ethics and R&D submissions
- Ensure the required approvals and agreements are in place before the trial opens to recruitment
- Setup trial specific procedures in accordance with company Quality Policies to ensure the efficient management of the trial
- Contribute to the successful launch of the trial including presentation at launch meetings
- Plan and perform site initiation visits ensuring sites have all applicable documentation in place and that principal investigators and site staff understand the protocol and their responsibilities within the trial
- Train relevant staff members in the operation of the MARIA™ system, including data review
- Liaise closely with the CI, Scientific Lead, statistician and other key members of the team to ensure on-going clinical, scientific and operational oversight
- Act as the principal point of contact for participating sites, regulatory authorities and the trial oversight committees
- Organise regular meetings of the clinical team, preparing the agenda and meeting papers, and provide minutes following the meeting in a timely manner
- Oversee the day-to-day conduct of the trial at participating sites, providing support and advice (including re-training where necessary) and addressing any logistical issues as they arise
- Coordinate any trial-related sample collections
- Perform monitoring visits to participating sites to verify trial activities are compliant with the trial protocol, and all applicable regulations
- Ensure trial recruitment and retention are monitored and establish procedures for dealing with problems arising from any shortfall in collaboration with relevant members of the team
- Update trial documentation as necessary e.g. protocols, trial guidance notes, case report forms (CRFs) and patient information sheets.
- Prepare and submit regular updates on recruitment and clinical progress in line with the trial protocols.
- Draft regular progress and safety reports e.g. to funding bodies, NCRI Clinical Studies Groups, main REC, MHRA.
- Contribute to the preparation of abstracts, posters and manuscripts.
- Maintain quality control procedures for all aspects of trial conduct to ensure compliance with the principles of Good Clinical Practice, research governance standards and all applicable legislation
- Maintain the Trial Master File to ensure a clear audit trail of trial activities is retained.
- Facilitate any audit, inspection or progress visit processes required by regulatory bodies, or sponsor(s)
- Develop and/ or revise training materials in response to feedback from system deployments
- Liaise with participating sites and potential collaborators to promote trial recruitment
- Plan, organise and give presentations at meetings of investigators/ research nurses/trial coordinators as appropriate
- Oversee the design and validation of the clinical study database
- Implement and oversee timely and efficient procedures for the collection, entry and verification of all patient data
- Maintain record management systems for all trial material
- Maintain up to date trial guidance notes for participating sites
- Liaise with site staff to ensure trial procedures are being followed to promote the reporting of high quality data
- Prepare data for interim and/or full analysis in collaboration with the trial data managers and statistician
New research initiatives
· With senior staff, prepare funding applications for new study proposals.
- Science Degree with significant med-tech/ pharmaceutical industry or clinical development/medicine experience
- Experience of site monitoring and study management responsibility is required.
- Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based)
- Knowledge of concepts of clinical research and device development
- General therapeutic area education and training
- Ability to handle and prioritize multiple tasks simultaneously
- Work effectively in a team/matrix environment
- Ideal but not essential, have worked in breast imaging
- Understand technical, scientific and medical information, excellent technical writing skills
Any other duties as may be required which are consistent with the nature and grade of the post.
This job description is a reflection of the present position and is subject to review and alteration in detail and emphasis in the light of future changes or developments.
To apply please send your CV and any covering letter to firstname.lastname@example.org by the 31st Jan
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