Clinical Trial Data Manager

Job description

Job responsibilities

Creation and maintenance of files for clinical trials, collection of trial data, creation and completion of case report forms and the creation and maintenance of a database of trial activity.Uses own initiative, takes responsibility for decision making and can prioritise own workload.Ensure all work is carried out in line with study protocols, ICH-GCP, and allassociated regulations and good practice guidelines.Have a thorough understanding and knowledge of study protocols and associated study documents.

Establish and maintain good channels of communication with the clinical team, Trial Management Teams, and the wider multi-disciplinary team.

Liaise with sponsor offices, trial management teams and investigators, and other organisations and teams as required to support any study amendment as required, ororganisations and teams as required to support any study amendment as required, or to resolve any ongoing issues that may arise from time to time especially date queries.Participate in study meetings and provide update reports and presentations as appropriate.Leads on the completion of case report forms with clinical data from trial patients as per individual study requirements.Ensures case report forms are completed to a high quality, accurate and sent in a timely manner.Acts to resolve issues with source data and anomalous data at the time of reporting, reviewing against previously reported data as well as local and national normal ranges.

Prioritises workload to ensure all data queries are dealt with in a timely and efficient manner.Use scientific judgement on the nature of the clinical data returns and clinical data queries.

Escalates issues to senior team members appropriately.

Develop systems for improving the collection of accurate and timely source data.Plans work across a portfolio of clinical trials according using appropriate judgement with reference to specific deadlines, expected turn-around times and clinical importance.Creates and maintains both paper and electronic trial site files.Creates and maintains files of current protocols and patient informationsheets/consent forms in the appropriate clinics and departments.Maintains list/database of up-coming, current and recently closed clinical trials.Maintains electronic and paper list of accruals to trials.

Assists with the collation of trial performance data in preparation for internal meetings.Organises and prepares documentation for audit and monitoring visits.Consults with primary investigators, research organisations and industry in the development and delivery of research protocols.

Follows Standard Operating Procedures (SOPs) and highlights any issues arising.Participates in the development of the SOPs.Assists research nurses and clinicians in ensuring trial protocols are accurately followed.Able to operate effectively under pressure and use own initiative and judgement.Competent in the use of the software and stays up-to-date with new versions of the software.Communicates effectively with all key personnel across the Multidisciplinary Team (MDT).High level communication skills are used to ensure all members of the MDT have the necessary information about trial data.

Liaise with research nurses, clinicians and other members to the MDT to answer any trial related data queries.Provides feedback when required, during team meetings about trial status, patient recruitment etc.

Continually reviews data processes and workflows for efficiency and effectiveness and proactively strives to achieve continual service improvements.Prepares study data and presents in a variety of mediums at internal and external organisations to ensure successful delivery of trials.Ensuring safe standards of practice at all time through identification of areas of risk associated with participation in research studies.Ensuring study data is collected and managed in accordance with ICH GCP.

Be efficient, meticulous and able to manage their own workload.Have excellent communication skills with all disciplines, including participants, immediate colleagues, the wider team and other internal and external agencies.Be flexible in work practices and time, and be able to work with little or nodirect supervision whilst recognising own limitations.

Person Specification

Training and Qualifications

Essential

• Knowledge of ICH GCP
• Knowledge of drug development process and clinical trials

Desirable

• Life Science or computer science/IT degree or equivalent experience
• Hold a Good Clinical Practice certificate

Experience

Essential

• Experience of working under minimal supervision

Desirable

• Experience of working on clinical trials

Skills

Essential

• Database and data management skills
• Experienced in the use of MS Word, Excel, Powerpoint

Desirable

• Experience of using clinical trial web based data capture systems e.g. MediData Rave

Certificate of Sponsorship

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).

Employer details

Employer name

University Hospitals of Leicester NHS Trust

Address

Leicester General Hospital

Gwendolen Road

Leicester

LE5 4PW

Employer's website

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