Why is this Job Description being written? New Position Replacement Position Position re-designed Position not previously described

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1 Why is this Job Description being written? New Position Replacement Position Position re-designed Position not previously described P O SITION DET AI L S: Position Title: C LI NICAL DATA MAN AGER Division: Chronic Diseases of Childhood Department: Children s Diabetes Research and Education Centre Position reports to: (role) Research Manager Location: include all possible locations 0 Roberts Road Subiaco P O SITION PURPOSE: In one or two sentences briefly summarise the overall purpose of this role, i.e. broadly, what this role does and why The Clinical Data Manager and Analyst is responsible for the administration and analysis of a wide range of data collected in the various trials undertaken by WA Children s Diabetes Research and Education Centre ( The role involves facilitation of various methods of data capture (eg: electronic case report forms, blood glucose monitoring software, patient databases) and migration of data from multiple sources to common databases for latter analysis by biostatisticians and other researchers. The role will also involve the development of an analytic dataset of original and derived variables for future planned multicentre clinical trials as well as providing expertise on data collection, analysis and reporting to researchers. K E Y R E SP ON S IBI LIT Y AREAS (Please list in order of importance) Key Position Accountabilities What are the main areas for which the position is accountable % of Total Role Inputs: What are the key activities or tasks to be carried out? Outputs: What are the expected end results? Measures: How it is measured

2 Database coordination 30 Oversee the acquisition, curation and provision of clinical trial datasets from a variety of sources such as patient databases, electronic case report forms and blood glucose management software Accurate and efficient coordination of a wide variety of data from clinical trials Establishment and maintenance of a variety of data sets Data acquisition and organisation 30 Implements and enforces, and advises researchers, proper data collection policies and procedures Assists with data entry and migration where necessary Develops data collection and evaluation methodologies, including format design, project criteria and requirements, data compilation, relevancy and usage Integrate data within studies into a central repository and ensure data is appropriately cleaned, validated, organised and audited Set up procedures/processes for quality assurance and data validation Develop appropriate documentation of data such as data dictionaries Successful capture and collection of data Questionnaire design Database development Electronic case report form design Enable researchers to easily interpret study data Successful collection of data from a variety of sources Provision of high quality data for publication Comprehensive use of data by researchers Data quality Establishes data quality standards Performs and documents procedures for data preparation including data cleaning, standardization and analysis Reviews and audits data input from clinical trial sites in electronic case report forms for quality and completeness and reports any issues to the relevant project manager High quality (clean) data disseminated High quality data collected from clinical trial sites and resolution of any issues Provision of high quality data for publication Data analysis Interpret results and contribute to the preparation of journal articles/reports and provide study progress reports to projects manager and trial team Consults with staff on data coding problems and assists in developing means to correct the problems Preparation of analytical datasets Creation of data outputs and statistical calculations as required Prepare import/analysis code for statistical analytical software Studies appropriately designed to address research questions posed High quality manuscripts suitable for publication Clearly communicated progress updates provided to clinical trial team Statistical techniques applied appropriately, accurately and efficiently Demonstrated ability to interpret and communicate results clearly

3 Data extraction Collaboration/Supervision Risk Management 5 5 E SSENTIAL SKI LLS, KN O W LE DG E A ND EXPE RI ENCE: Liaise with researchers regarding their research interests and data needs Provide timely and accurate responses and support to requests for data Collaborate with stakeholders including researchers, statisticians, students, institutions and centres as required Advise researchers and students on best practice for data collection dependent on the type of trial they are running Develop protocols for safe storage and access to data. Develop strategies for de-identification and re-identification of data Ensure protocols are established and met in relation to confidentiality and data access Ensure security of all study data Provide appropriate data to address research questions posed Successful collaboration with stakeholder s Increased upskilling of students and other researchers Encryption De-identification Records maintained Provision of accurate information and data in a timely fashion to support production of high quality publications Publications Improved knowledge of data management practices by research team Security Confidentiality maintained Qualifications: what are the minimum educational, technical or professional qualifications required to competently perform role Relevant Tertiary qualification (e.g. computer science, bioinformatics, information systems, statistics, mathematics, health sciences or other relevant discipline)

4 Skills, Knowledge & Experience: D E SIRA BLE S K ILLS, KN O W LE DG E A ND EXPE RI ENCE: Experience managing clinical trial data Relevant analytical and database management experience at an appropriate level Experience with one or more database packages (E.g. Access, FMP, Excel) for data acquisition Experience in the maintenance and manipulation of large datasets Experience with one or more statistical software package (E.g. SAS, STATA, R, SPSS) for manipulation and analysis of data sets Understanding of issues about data confidentiality/security/privacy Demonstrated ability to establish and maintain excellent working relationships with internal and external stakeholders at all levels and work effectively as part of a team in a collaborative environment Working understanding of the nature of research and research environments Ability to work independently, show initiative and contribute to a team Excellent verbal communication skills, including the ability to explain technical concepts Ability to work in a multi-disciplinary environment Ability to achieve targets within set time frames Demonstrated ability to pay attention to detail and ensure work is of high quality Willingness to learn new technologies and techniques, through in-house and external training Ability to prepare reports and accurately document work/processes Qualifications: what are the minimum educational, technical or professional qualifications required to competently perform role Skills, Knowledge & Experience: SCOPE: Postgraduate qualification in a relevant area Experience in managing or using health databases Experience in using hospital administrative datasets Experience in analysing linked health data. Familiarity with modern classification and regression techniques or data mining. Financial accountability: Does this role have accountability for a budget? No People responsibility: Does this role have any direct reports or indirect reports (through direct reports)? No. of direct reports 0 No. of indirect reports 0

5 O R GANISATIONAL C HA RT : (please complete using position titles or insert diagram below) Next level of supervision Directors/Heads of Department Immediate level of supervision Research Manager Other roles reporting to immediate supervisor Research Assistant Biostatistician Clinical Data Manager Clinical Research Associate Project Manager Admin Assistant Direct reports (role x no.) A D DITION AL INFORMA T I ON: is there any additional information that needs to be understood to explain this role?

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