Clinical Data Manager

Date: 18 Feb 2025

Site: VCCC (Parkville)

Location:

MELBOURNE, VIC, AU, 3000

Company: Peter MacCallum Cancer Centre

Unit: Biostatistics & Clinical Trials

Division: Cancer Research

Department: Office Of Cancer Research

Enterprise Agreement: Health and Allied Services, Managers and Administr

Biostatistics & Clinical Trials

At Peter Mac we aim to continuously improve cancer care, research and education across all cancers and for all people affected by cancer: changing lives, breaking new ground. Everything we do is underpinned by our core values, Excellence, Compassion and Innovation. Welcoming people from a wide variety of different backgrounds and experiences is critical to fostering innovation, cultivating compassion, attracting and retaining top talent and providing the best possible cancer care for our patients.

YOUR ROLE IN OUR FUTURE

Clinical Data Manager - Biostatistics

24-months Fixed-Term, Full-Time
80 hours per fortnight with monthly ADO's
Attractive salary packaging offers available

The successful candidate will liaise with study site staff supporting quality clinical data entry and cleaning process, provide input during the development of clinical trial databases and ensure data management functions can adequately be performed and ensure that data management documentation of processes and procedures are in place to ensure quality management requirements are met in a timely manner for clinical trials in line with regulatory requirements.

The ideal candidate will meet the following essential requirements:

Life Sciences/Information Technology graduate (or equivalent) or, relevant experience working in a clinical trial / pharmaceutical / research environment or Contract Research Organisation (CRO).
Must have experience working with databases (preferably clinical data), and a high level of understanding of data management procedures
Familiarity with ICH-GCP, 21 CFR Part 11
Firm understanding of the drug development process.
Must be a team player with the ability to work in a multi-disciplinary environment.
Strong interpersonal and communication skills, both verbal and written.
Excellent conceptual thinking skills.
Strong operational and planning skills in order to meet deadlines and to handle multiple studies.
Must be accurate with an excellent attention to detail and a methodical approach to work.
Proficiency with common business software.
Able to work independently, be self directed and capable of working to deadlines.

Applicants to this role should provide a covering letter outlining relative key skills and experience to assist us with our assessment.

For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position summary. Alternatively, please contact us using the information below for a confidential discussion.

Hiring Manager: Emma Callegari
Email: Emma.Callegari@petermac.org

Applications Close: 5th March 2025
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Position Summary

To liaise with study site staff supporting quality clinical data entry and cleaning process
Provide input during the development of clinical trial databases and ensure data management functions can adequately be performed.
To ensure that data management documentation of processes and procedures are in place to ensure quality management requirements are met in a timely manner for clinical trials in line with regulatory requirements.

Enterprise Agreement

Health and Allied Services, Managers and Administrative Workers (Victorian Public Sector) (Single Interest Employers) Enterprise Agreement 2021-2025

Classification or Salary Range

Dependent on experience

Immunisation Risk Category

Immunisation Category C

Key Relationships

Internal	Business Planning and Operations Manager Database Design and Development Team Clinical Trial Management Team Peter Mac Study Investigators Statisticians
External	Clinical Trial Principal Investigators Clinical Trial Site Staff Clinical Trials Sponsors Representatives including pharmaceutical and collaborative groups( local and global) Data Management Vendors Public and Private Hospitals

Education

Bachelor of Information Technology

Skills

Essential Requirements

Life Sciences/Information Technology graduate (or equivalent) or, relevant experience working in a clinical trial / pharmaceutical / research environment or Contract Research Organisation (CRO).
Must have experience working with databases (preferably clinical data), and a high level of understanding of data management procedures
Familiarity with ICH-GCP, 21 CFR Part 11
Firm understanding of the drug development process.
Must be a team player with the ability to work in a multi-disciplinary environment.
Strong interpersonal and communication skills, both verbal and written.
Excellent conceptual thinking skills.
Strong operational and planning skills in order to meet deadlines and to handle multiple studies.
Must be accurate with an excellent attention to detail and a methodical approach to work.
Proficiency with common business software.
Able to work independently, be self directed and capable of working to deadlines.

Certifications, Licenses & Registrations

Key Accountabilities

Key Accountabilities	Demonstrated by / Key Performance Indicators
1. Data Management	Responsible for the management of timely, high quality delivery of clinical data for clinical trials in line with study protocol requirements which include: o Protocol review to ensure data captured and managed appropriately o Collaboration in defining and develop data quality checks with study team. o User testing and validation of eCRF and study database o Protocol data entry management and support for participating study sites, including query generation and reconciliation. o Development of reports and tools to enable resource and timeline requirements to be effectively forecast, budgeted and managed for a project. Also, site data status reports. o Collaborate and co-ordinate with other functional groups to ensure integration of data delivery meet required timelines o Ensure activities are performed in line with regulatory guidelines. o Provide training, guidance, assistance and technical support to study team and sites as required to facilitate the effective use of the study database and report functionality. o Consideration to impact of new developments and factor these into existing processes. o Proactively seeks innovative ways to improve data management functions. Communicates potential improvements to clinical team. o Undertake additional tasks deemed necessary to meet business needs e.g. site / investigator data management support.
2. Quality Processes	Contribute to key study documents including Data Management Plan (DMP), CRF Completion Guidelines and Data Review Conventions to provide planning, communication and reference tools for the study team, providing a record of data handling activities for the study. Perform user acceptance testing (UAT) of the CRF and study database (including a review of database structure, data entry screens and data quality checks) to ensure that the data collection modules are designed and sequenced according to protocol and in compliance with protocol Develop data development / management SOPs as applicable.
3. Professional and Personal Development	Attends relevant educational / professional forums. Participates in team and departmental meetings. Professional development is maintained and promoted. Maintain working knowledge of ICH GCP and appropriate regulatory guidelines.

Key Accountabilities (Contd..)

Key Accountabilities

Demonstrated by / Key Performance Indicators

4. Leadership and Engagement

Work to foster good relationships and increase profile of BaCT within PeterMac and external parties
Establish effective communication strategies fostering open and effective lines of communication at all levels.
Contribute to study team meetings.
Ensure CRF training is provided and data management requirements are communicated.
Provide regular detailed feedback regarding study status and data quality issues to study team using metrics to identify and improve processes.
Facilitate effective use of database to internal and external customers and report functionality.
Assist in the leadership and conduct of specific projects as required.
Ensure clinical project management requirements are communicated.
Provide regular detailed feedback regarding study status and data quality issues to study team using metrics to identify and improve processes.

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For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position profile. Alternatively, please contact us for a confidential discussion.

Peter Mac is a child safe organisation and has a commitment to child safety and wellbeing.

WHY WORK FOR PETER MAC

Peter Mac offer a range of benefits which support our people both personally and professionally.
Our staff benefits include award winning facilities, professional development and events, a health and wellbeing program, flexible work practices and policies and financial benefits such as salary packaging.
We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQI community and people with a disability.