Senior Clinical Trials Data Manager

Job description

Job responsibilities

DUTIES AND RESPONSIBILITIES

TEAM SUPPORT

Responsible for supporting and supervising workload allocation/monitoring across administrative team members, escalating issues to appropriate senior managers.

Provide support to senior managers with general Human Resource activities, including but not limited to recruitment and selection and line management of administrative team members as required. This will be in accordance with Trust policies.

Provide induction support and training to new and existing clinical trials staff through one-to-one and group learning activities.

Develop and maintain training and induction materials for the data management team.

Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration staff.

Assist with data collection for data entry metrics and query resolution metrics for the clinical research team.

DATA MANAGEMENT

Act as a point of contact for the core Research and Development team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data entry and queries, monitoring visits and other enquiries relevant to general trial conduct.

Ensure the timely set up and initiation of source data workbooks for review by the lead Research Nurse and ensure version control is appropriately maintained.

Track all payments throughout each clinical trial including completion of activity logs ensuring that all research activity is recorded to facilitate full cost recovery.

Perform audits and spot checks on costings spreadsheets to ensure quality of income recovery.

Assist with the maintenance of the investigator site files and essential documentation (filing consent forms and enrolment forms and completing patient logs) in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times.

Responsible for keeping trial folders, including blood results and laboratory requisition forms up to date in accordance with the studys standard operating procedure.

Ensuring team reporting mechanisms are kept up to date (i.e. recruitment activity logs, patient visit logs, costings spreadsheets, CRF trackers, electronic proformas, serious adverse events trackers, data entry metrics trackers and workbook trackers).

Ensure collection and tracking of clinical case notes for all patients, so that these are available as needed, for monitoring and audit purposes.

Ensure that data collected for all trials meets protocol requirements and is complete and accurate and monitor this if necessary.

To check the validity and completeness of research data collected within the Trust and take action to obtain or correct missing or contradictory data.

Oversee and complete case report forms as per sponsor requirements to meet data entry deadlines stipulated in the clinical trial protocol and/or contract.

To resolve queries by initiating correspondence or direct contact with the research nurses/clinicians and other relevant health care professionals ensuring that reporting timelines are met.

Provide information for senior managers including (but not limited to) case report from completion timeliness, data locks, data backlogs and workload allocations.

Support the clinical research nurses to ensure that reports of serious adverse events are returned to co-ordinating centres/sponsors within the standard time frame.

Resolve or escalate any concerns relating to protocol adherence, data quality, handling of confidential data or meeting timelines.

Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper sources.

Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in nature.

To ensure confidentiality and security of patient data at all times, particularly when transferring data outside of the Trust.

Arrange shipping and delivery of relevant trial data and documents including import/export of anonymised ECGs and copy scans.

Arrange team and trial related meetings as required, producing minutes in a timely manner.

Ensure that data is available and up to date for any meetings related to a clinical trial.

If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) and Site Initiation Visits to convey the relevant information to the study team.

Prepare for audits and inspections within assigned teams.

Ensure that all documents including patient workbooks, blood results and other trial related documents are archived in the appropriate way by following the Trusts archiving guidelines.

Undertake general administrative tasks as delegated by managerial representatives from the Research Division to contribute to the smooth running of the patient recruitment teams.

WORKING PRACTICE

Work closely with the Senior Research Management Team to implement new SOPs and working procedures within designated teams.

Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.

The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to senior managers as necessary.

The post holder is guided by relevant protocols and SOPs, and is expected to exercise judgement outside these areas.

PERSONAL DEVELOPMENT

Maintain professional development whilst evaluating own specialist knowledge with assistance from their assigned line manager to satisfy the NHS Knowledge and Skills Framework.

Participate in and deliver Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.

Act in accordance with The Christie Values & Behaviours Framework at all times.

Person Specification

Qualifications

Essential

• Degree in a science or health related discipline or Relevant experience in scientific and medical research.

Desirable

• Post graduate certificate in clinical research or other relevant post graduate qualification.

Experience

Essential

• Significant experience in clinical trial administration or clinical trial data management.
• Experience of mentoring junior staff members or colleagues.

Desirable

• Previous experience of working within the NHS or other healthcare system.
• Direct line management experience.
• Experience in the use of iMedidata RAVE, InForm, RDC Onsite or other electronic case report forms.

Skills

Essential

• Ability to prioritise own and others workload and practice effective time management.
• Excellent interpersonal skills.
• Tactful and diplomatic.
• Excellent oral and written communication skills.
• Good IT skills including proficiency in the Microsoft Office suite.
• Attention to detail.
• Conscientious and hardworking

Desirable

• Advanced use of spreadsheets.
• Strong understanding of case report form design
• Evidence of achievement under pressure.

Knowledge

Essential

• Good understanding of the clinical research delivery processes, related standards, governance and legislation.

Desirable

• Understanding of medical terminology and cancer.
• Knowledge of patient information systems.

Values

Essential

• Ability to demonstrate the organisational values and behaviours of The Christie NHS Foundation Trust.

Other

Essential

• Ability to work to tight and/or unexpected deadlines.
• Ability to work unsupervised or as part of a team.

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.

Employer details

Employer name

The Christie NHS FT

Address

Phase 1 - Q01312

Manchester

M20 4BX

Employer's website

https://www.christie.nhs.uk/ (Opens in a new tab)