Head of Data (Bayswater)

Head of Data (Bayswater)

26 Sep
|
Veritus Research
|
Bayswater

26 Sep

Veritus Research

Bayswater

About the role The Head of Data is accountable for the data governance strategy, systems and controls that protect the integrity, reliability and traceability of clinical trial data across Veritus Research.

As part of the senior leadership team and reporting to the COO, the Head of Data will build and lead the data function, establishing a data governance framework across Veritus Research aligned with ICH GCP E6(R3).

Benefits of the Role

- Join a fun, innovative and motivated team – we work together to support each other and grow our business
- Be part of the senior leadership team with the opportunity to build and shape the Data function
- Play a key role in embedding ICH GCP E6(R3) across Veritus Research
- Opportunities to shape the function, broaden your impact and continue your professional development
- Free on-site parking available

Key responsibilities

- Lead the development and implementation of Veritus Research's data governance framework aligned with ICH GCP E6(R3)
- Build and lead the data function, establishing the team, systems, processes and controls required to support clinical trial data governance
- Establish governance across the full data lifecycle, including data capture, review, correction, transfer, retention and archiving
- Maintain oversight of computerised systems, including validation, security, user access, audit trails, backup and associated risks
- Ensure appropriate controls are in place to maintain data integrity, participant privacy and confidentiality, and ALCOA+ principles
- Establish risk-based processes for the review of trial data, audit trails and relevant metadata
- Partner with Quality,



Projects and other operational leaders to embed data governance requirements into the QMS and day-to-day clinical trial activities
- Maintain oversight of data-related risks, ensuring appropriate investigation, escalation and remediation
- Lead data governance and computerised systems readiness for sponsor/CRO audits and regulatory inspections
- Provide the COO and senior leadership team with clear reporting on data governance performance, system validation and data integrity risks

About you

- Tertiary qualification in Data Management, Health or Life Sciences, Information Systems, Clinical Research or a related discipline
- Significant experience in clinical research, pharmaceuticals or another highly regulated environment
- Solid working knowledge of ICH GCP and the data governance requirements under ICH GCP E6(R3)
- Demonstrated experience with data integrity principles, including ALCOA+, and computerised systems validation
- Experience with clinical trial technology such as EDC/eSource, CTMS, eTMF, IRT or equivalent regulated systems
- Experience preparing for or supporting sponsor/CRO audits and regulatory inspections
- Proven ability to translate regulatory requirements into practical systems, processes and controls
- Strong analytical, leadership and stakeholder management skills, with the ability to influence across multiple disciplines

About us Veritus Research improves world health by expertly managing clinical trials to accelerate medical advancements.

We are a Phase I to IV clinical research unit in Bayswater, running clinical trials for sponsors and CROs across Australia and internationally. Our purpose-built facility and dedicated clinical team enable us to support studies from first-in-human dosing through to database lock, with participant safety and data integrity at the forefront of everything we do.

📌 Head of Data (Bayswater)
🏢 Veritus Research
📍 Bayswater

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:

Get the latest job offers by email for: head of data (bayswater) / bayswater

Subscribe to this job alert:

Get the latest job offers by email for: head of data (bayswater) / bayswater