06 Aug
|
PYC Therapeutics
|
New South Wales
06 Aug
PYC Therapeutics
New South Wales
7d ago , from Illawarra Mercury Job Board
Life‑changing science is our focus; we start there and everything else follows.
PYC Therapeutics is a clinical-stage biotech company discovering and developing RNA therapies designed to transform outcomes for patients living with rare genetic diseases.
We are entering a pivotal stage of growth as we advance our clinical programs, expand our pipeline, and continue building our position as a global RNA therapeutics company. Our work spans inherited retinal disease, polycystic kidney disease, and neurodevelopmental disorders, alongside a broader discovery pipeline.
With our clinical programs continuing to progress, we are seeking a Clinical Study Manager to oversee the operational delivery of PYC’s clinical studies. Reporting to the Clinical Operations Manager, you will manage CROs, vendors, clinical trial sites and internal stakeholders to ensure studies are delivered to a high standard, in line with study plans, timelines, quality expectations, Good Clinical Practice and applicable regulatory requirements.
This is a hands‑on sponsor‑side role with responsibility for study oversight, operational planning, risk management, quality oversight and cross‑functional coordination. You will play a key role in keeping studies on track, supporting solid site and vendor relationships, and ensuring operational issues are identified early and managed effectively.
Your key responsibilities will include:
- Oversee the day‑to‑day operational delivery of assigned clinical studies from feasibility and start‑up through to close‑out.
- Manage CROs, vendors and clinical trial sites to support delivery against agreed scope, timelines and quality standards.
- Contribute to the development and review of study plans, protocols, informed consent forms and study‑related documents.
- Monitor study progress, milestones, risks, budget assumptions and operational deliverables.
- Maintain oversight of study quality, site operations, data integrity and inspection readiness.
- Identify and elevate operational risks, quality issues and study delivery challenges, implementing practical mitigation strategies where required.
- Provide clear study updates, reports and operational input to support governance and decision‑making.
- Perform quality oversight visits and support audit or inspection preparation as required.
This is a full‑time opportunity, based in Sydney. Ability to travel up to 25% of the time as required to conduct clinical study site visits or participate in engagement visits and conferences
About You
You are an experienced clinical research professional who can take ownership of study delivery across CROs, vendors, sites and internal teams. You bring robust clinical operations experience, sound judgement and a practical approach to managing risks, solving problems and keeping studies on track.
You are proactive, organised and collaborative, with strong relationship‑building skills and the attention to detail needed to support high‑quality, compliant study delivery. Sponsor‑side,
CRO or clinical site experience within the Australian clinical trial environment will be highly valued.
You will also have demonstrated experience in the following:
- Minimum 7 years clinical research experience, including experience in clinical trial or clinical study management.
- Managing CROs, vendors, clinical trial sites and external study partners.
- Working knowledge of ICH‑GCP, clinical trial regulations and applicable regulatory requirements.
- Study start‑up, operational delivery, documentation management and quality oversight activities.Tracking study progress, risks, actions and deliverables across internal and external stakeholders.
- Strong organisational, communication and problem‑solving skills, with high attention to detail.
- Relevant qualification in life sciences, health sciences, nursing, pharmacy or a related field, or equivalent clinical research experience.
- Current GCP training or willingness to maintain current GCP certification.
We are building a high‑performance, science‑led organisation where curiosity, collaboration, and pace matter.
Working at PYC provides the opportunity to:
- Contribute to clinical programs focused on rare genetic diseases with real patient impact.
- Build your clinical operations career within a growing clinical‑stage biotechnology company.
- Work alongside experienced clinical development, quality and research professionals.
- Gain exposure across multiple clinical studies and global development activities.
- Access flexible working arrangements and additional leave benefits.
Closing Date: 7 August 2026 – PYC Therapeutics reserves the right to hire prior to the closing date.
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📌 Clinical Study Manager (New South Wales)
🏢 PYC Therapeutics
📍 New South Wales