Job summary
The Senior Data Manager will be based in the Late Phase Haematology Research (LPH), which conducts a wide spectrum of clinical research in haematology predominantly in phase II/III. Professional responsibilities include education of colleagues, leading on all aspects of clinical research data management. Managerial responsibilities include leading and developing the Trial Data Team and being instrumental in implementing agreed team objectives to enhance performance. The post holder will be expected to have specialist skills and knowledge relating to clinical research data management and quality assurance, ideally gained in cancer trials setting.
Main duties of the job
The post holder will be responsible for overseeing the data management team fat the Churchill Hospital in Oxford. The main duties of the Senior Data Manager are:
- Line manage the data entry staff
- Provide leadership and expertise in clinical research data management.
- To manage the research administrative databases.
- Manage requests for activity data. Generate and interpret management reports on request, using appropriate database, spreadsheets and statistical tools effectively.
- Manage complex, highly detailed medical research data sets. Will plan and apply appropriate data capture, validation, verification and cleaning techniques.
- Ensure the effective delivery of high quality research data sets to agreed deadlines.
- Maintain and continually develop specialist knowledge of clinical data management and trial methodology, providing professional leadership and direction to the research effort.
About us
About us
RISK MANAGEMENT
The management of risk is the responsibility of everyone and will be achieved within a progressive, honest and open environment.
RESPONSIBILITIES FOR HEALTH & SAFETY
The post holder is responsible for ensuring that all duties and responsibilities of this post are carried out in compliance with the Health & Safety at Work Act 1974, Statutory Regulations and Trust Policies and Procedures. This will be supported by the provision of training and specialist advice where required.
INFECTION CONTROL
Infection Control is everyone's responsibility. All staff, both clinical and non-clinical, are required to adhere to the Trusts' Infection Prevention and Control Policies and make every effort to maintain high standards of infection control at all times thereby reducing the burden of Healthcare Associated Infections including MRSA.
SAFEGUARDING CHILDREN AND VULNERABLE ADULTS
The Trust is committed to safeguarding children and vulnerable adults throughout the organisation. As a member of the trust there is a duty to assist in protecting patients and their families from any form of harm when they are vulnerable.
INFORMATION GOVERNANCE
All staff must complete annual information governance training. If you have a Trust email account this can be completed on-line, otherwise you must attend a classroom session.
Job description
Job responsibilities
Management
- Act as a leader, resource and role model.
- Take responsibility for the day to day management and supervision of the Trial Data Team.
- Lead on the appointment of new staff.
- Facilitate regular and effective appraisal for the Trial Data Team and to support appropriate training and development opportunities in line with role requirements and team objectives.
- Be responsible for the co-ordination and management of leave of the Trial Data Team.
- In conjunction with management, review and lead the development and implementation of data systems.
- Co-ordinate and allocate clinical trials within the Trial Data Team.
- In conjunction with the Senior Research Nurse, monitor and plan in advance the workload of the Trial Data Team, ensuring that it is adequately resourced.
- Manage own caseload of trial data management.
- Be aware of and adhere to all Trust and locally agreed policies or SOPs
- Represent the LPH data team at wider departmental and Trust levels as agreed.
- Be responsible for own professional development in conjunction with the objectives identified at appraisal and the service.
Quality and administration
- Become fluent in the development and use of e-based systems for document control and research management and training others in their use.
- Maintain research staff records required to demonstrate compliance with GCP. Alert research staff to any omissions in their training record and operate a reminder system to ensure that they complete the required training in a timely fashion.
- Develop and maintain administrative databases, producing management reports on activity and performance metrics.
- Act as a contact point for Trust R&D Department and Thames Valley and South Midlands Cancer Research Network for advice on data reporting and requests for activity reports.
- Author and review relevant Standard Operating Procedures (SOPs)
- Support quality aspects, such as organising/ hosting Audit and Inspections, CAPA and internal QC / monitoring.
- Be aware of and adhere to our Quality Policy, applicable standard operating procedures and all Trust and locally agreed policies. Collaborate with other research and healthcare professionals to ensure these are observed.
- Act as a resource, supporting and motivating staff and researchers in standard operating procedures, providing training and explaining the reasons/ principles behind them.
Data Management
- Work closely with the Senior Research Nurse and research team, coordinating workloads and priorities for data management, assigning projects and negotiating deadlines to meet Case Report Form (CRF) completion priorities.
- Interpret and extract data from the source medical records to paper or electronic case report forms as required by the trial protocol and other applicable instruction.
- Responsible for ensuring that the Trial Data Team produce complete, accurate data sets ready for data lock and analysis to agreed deadlines.
- Receive data queries, liaising with responsible clinical research staff and monitors as necessary to resolve any missing or discrepant data and respond to the originator.
- Apply knowledge and understanding to proactively identify exceptions that might impact on the trial (e.g. possible protocol/ SOP violations, safety report omissions, complicated queries) and take appropriate action to report and resolve.
- Responsible for writing SOPs and work instructions covering the activities of the Trial Data Team and their interactions with other groups.
- Adhere to Good Clinical Practice in maintaining patient confidentiality and safety.
Study development, data management and coordination
Duties will be assigned on a trial specific/ as needed basis and may include some or all of the following:
- Critically review trial protocols and related research documentation for completeness, consistency, feasibility, resource implications and GCP compliance. Utilise knowledge in clinical trial research methodology, data management best practices and critical appraisal.
- Responsible for trial data handling, data entry, validation/ verification and report generation.
- Assist with the maintenance of the Investigator Site File.
- Work to support the timely set up, running and close down of clinical trials.
- Take an active part in trial meetings and act as point of communication with Sponsor, pharmaceutical companies and other external groups as appropriate.
- Provide the finance office with all necessary information pertaining to the financial impact of trial procedures conducted within the Trials Unit.
Job description
Job responsibilities
Management
- Act as a leader, resource and role model.
- Take responsibility for the day to day management and supervision of the Trial Data Team.
- Lead on the appointment of new staff.
- Facilitate regular and effective appraisal for the Trial Data Team and to support appropriate training and development opportunities in line with role requirements and team objectives.
- Be responsible for the co-ordination and management of leave of the Trial Data Team.
- In conjunction with management, review and lead the development and implementation of data systems.
- Co-ordinate and allocate clinical trials within the Trial Data Team.
- In conjunction with the Senior Research Nurse, monitor and plan in advance the workload of the Trial Data Team, ensuring that it is adequately resourced.
- Manage own caseload of trial data management.
- Be aware of and adhere to all Trust and locally agreed policies or SOPs
- Represent the LPH data team at wider departmental and Trust levels as agreed.
- Be responsible for own professional development in conjunction with the objectives identified at appraisal and the service.
Quality and administration
- Become fluent in the development and use of e-based systems for document control and research management and training others in their use.
- Maintain research staff records required to demonstrate compliance with GCP. Alert research staff to any omissions in their training record and operate a reminder system to ensure that they complete the required training in a timely fashion.
- Develop and maintain administrative databases, producing management reports on activity and performance metrics.
- Act as a contact point for Trust R&D Department and Thames Valley and South Midlands Cancer Research Network for advice on data reporting and requests for activity reports.
- Author and review relevant Standard Operating Procedures (SOPs)
- Support quality aspects, such as organising/ hosting Audit and Inspections, CAPA and internal QC / monitoring.
- Be aware of and adhere to our Quality Policy, applicable standard operating procedures and all Trust and locally agreed policies. Collaborate with other research and healthcare professionals to ensure these are observed.
- Act as a resource, supporting and motivating staff and researchers in standard operating procedures, providing training and explaining the reasons/ principles behind them.
Data Management
- Work closely with the Senior Research Nurse and research team, coordinating workloads and priorities for data management, assigning projects and negotiating deadlines to meet Case Report Form (CRF) completion priorities.
- Interpret and extract data from the source medical records to paper or electronic case report forms as required by the trial protocol and other applicable instruction.
- Responsible for ensuring that the Trial Data Team produce complete, accurate data sets ready for data lock and analysis to agreed deadlines.
- Receive data queries, liaising with responsible clinical research staff and monitors as necessary to resolve any missing or discrepant data and respond to the originator.
- Apply knowledge and understanding to proactively identify exceptions that might impact on the trial (e.g. possible protocol/ SOP violations, safety report omissions, complicated queries) and take appropriate action to report and resolve.
- Responsible for writing SOPs and work instructions covering the activities of the Trial Data Team and their interactions with other groups.
- Adhere to Good Clinical Practice in maintaining patient confidentiality and safety.
Study development, data management and coordination
Duties will be assigned on a trial specific/ as needed basis and may include some or all of the following:
- Critically review trial protocols and related research documentation for completeness, consistency, feasibility, resource implications and GCP compliance. Utilise knowledge in clinical trial research methodology, data management best practices and critical appraisal.
- Responsible for trial data handling, data entry, validation/ verification and report generation.
- Assist with the maintenance of the Investigator Site File.
- Work to support the timely set up, running and close down of clinical trials.
- Take an active part in trial meetings and act as point of communication with Sponsor, pharmaceutical companies and other external groups as appropriate.
- Provide the finance office with all necessary information pertaining to the financial impact of trial procedures conducted within the Trials Unit.
Person Specification
Job criteria
Essential
- Degree
- Clinical research in hospital setting
- Familiarity with eCRF databases
- Leadership skills
- Attention to detail
- Communication skills
- Project management
- Decision making
Desirable
- Post grad
- Experience in data management
- Knowledge of GCP
- Writing SOPs
Person Specification
Job criteria
Essential
- Degree
- Clinical research in hospital setting
- Familiarity with eCRF databases
- Leadership skills
- Attention to detail
- Communication skills
- Project management
- Decision making
Desirable
- Post grad
- Experience in data management
- Knowledge of GCP
- Writing SOPs
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
