The post holder would work within the structure of the Oncology Clinical Research Team under the direct supervision of the Research Team Leader and the overall supervision of the Research Operations Manager. The post holder will share/manage the workload of the team's clinical trials administration.
The role of the data manager is to contribute to the continued delivery of the highest quality research through the management of patient data relating to clinical research studies. The post holder will support the research nurses/practitioners and medical staff in the collection and processing of clinical trial data for the current portfolio of clinical trials in oncology. In addition, the post holder will assist to prepare for monitoring visits and liaise with trial sponsors to ensure timely transfer of data, and resolving any data queries.
The post holder will work within the guidelines of ICH GCP and local SOPs at all times. Other responsibilities will include conducting feasibility assessments, participating in quality improvement initiatives and the creation and maintenance of investigator site files and databases of clinical trial activity.
The post holder will be expected to have knowledge of cancer diagnosis and treatments and will be expected to develop skills and knowledge relating to the conduct of clinical trials in this area.
Be aware of and comply with ICH GCP as well as the legal requirements and other relevant guidelines for the conduct of clinical research.
To ensure trial case report forms (CRF) are completed in conformance with ICH GCP guidelines and within appropriate time guidelines.
In the event of a statutory inspection will assist the clinical team in preparing documentation and making necessary arrangements for the inspection in conjunction with the relevant trust departments.
To liaise with pharmacy, pathology, imaging and other trust departments to obtain relevant trials information
Resolve data queries by liaising with responsible clinical research staff and monitors as necessary to resolve any missing or discrepant data
To liaise in an efficient manner with the clinical teams and clinical trial sponsors with regards to clinical trial data
To support the research teams in the facilitation of efficient, safe and participant focused research
Demonstrate an understanding of the life cycle of a research project from inception to study close out supporting all clinical protocol related tasks to include accurate data capture in nursing and medical notes and accurate transfer of source data to case report form
To contribute to the recruitment of the local portfolio of Clinical research studies
At Imperial College Healthcare you can achieve extraordinary things with extraordinary people, working with leading clinicians pushing boundaries in patient care.
Become part of a vibrant team living our values - expert, kind, collaborative and aspirational. You'll get an experience like no other and will fast forward your career.
Benefits include career development, flexible working and wellbeing, staff recognition scheme. Make use of optional benefits including Cycle to Work, car lease schemes, season ticket loan or membership options for onsite leisure facilities.
We are committed to equal opportunities and improving the working lives of our staff and will consider applications to work flexibly, part time or job share. Please talk to us at interview. .
The full job description provides an overview of the key tasks and responsibilities of the role and the person specification outlines the qualifications, skills, experience and knowledge required.
For both overviews please view the Job Description attachment with the job advert.