Site & Clinical Study Management

• Identify and evaluate investigational sites to meet sponsor objectives.
• Partner with Clinical Operations and Regulatory teams to ensure timely ethics and regulatory submissions and approvals.
• Ensure investigational site personnel receive appropriate protocol and study training.
• Organise and participate in Investigator Meetings where required.
• Oversee study logistics to ensure investigational sites maintain appropriate study supplies.
• Monitor site activation, recruitment and retention performance.
• Develop and implement recruitment recovery plans where enrolment targets are at risk.
• Review monitoring visit reports to ensure protocol compliance, consistency of monitoring activities and timely issue resolution.
• Ensure safety reporting procedures are implemented and followed.
• Support CRAs to ensure monitoring activities, eCRF completion and query resolution are completed within sponsor timelines.
• Collaborate with Data Management to ensure data quality and study milestones are achieved.
• Work alongside Pharmacovigilance teams to coordinate safety management activities and Safety Review Committee activities where applicable.

TMF, Quality & Inspection Readiness

• Ensure the Trial Master File (TMF/eTMF) is established, maintained and quality controlled throughout the study.
• Review and approve essential documents required for site activation.
• Ensure Investigational Product (IP) management complies with study protocol and ICH-GCP requirements.
• Oversee study reconciliation, archiving and close-out activities.
• Maintain inspection and audit readiness throughout the project lifecycle.
• Lead responses to audits and regulatory inspections in collaboration with cross-functional teams.

Client Relationship Management

• Serve as the primary point of contact for assigned sponsors.
• Build trusted client relationships through proactive communication and delivery excellence.
• Provide regular written and verbal study updates, project reports and risk assessments.
• Lead sponsor meetings, governance meetings and project teleconferences.
• Facilitate communication between sponsors, clinical sites and internal project teams.
• Advise sponsors on local regulatory requirements and operational considerations.
• Proactively identify issues and implement appropriate mitigation strategies.

Continuous Improvement & Leadership

• Ensure compliance with Novotech policies, SOPs and quality standards.
• Support the review, development and implementation of SOPs and operational processes.
• Identify opportunities to improve project delivery and operational efficiency.
• Support feasibility assessments alongside Business Development.
• Identify opportunities to expand sponsor relationships and support business growth.
• Participate in Bid Defence Meetings where required.
• Represent Novotech professionally with sponsors, investigators and at industry conferences and meetings.

About You

You are an experienced clinical project leader who thrives in a fast-paced global environment. You have exceptional organisational, leadership and stakeholder management skills and are passionate about delivering high-quality clinical trials while building strong client relationships.

Qualifications & Experience

• Bachelor's degree in Life Sciences or a related discipline.
• Minimum 5 years' experience within the clinical research industry.
• Previous Clinical Project Management experience, including Associate Project Manager or equivalent.
• Strong understanding of the complete clinical trial lifecycle from feasibility through study close-out.
• Comprehensive knowledge of ICH-GCP, global clinical trial regulations and regulatory requirements.
• Proven experience managing global cross-functional clinical teams.
• Experience managing project budgets, timelines, forecasting and financial performance.
• Strong risk management and problem-solving skills.
• Excellent client-facing, communication and stakeholder management skills.
• Experience using CTMS, eTMF and other clinical trial management systems.
• Previous CRO experience.
• Experience across multiple therapeutic areas and global clinical studies.
• Experience participating in Bid Defence Meetings.
• Vendor oversight and outsourcing management experience.

Novotech Commitment

We are committed to a transparent recruitment process. Where a salary range is not included in this job advertisement, shortlisted candidates will receive the applicable salary range before their first interview, in accordance with applicable local legislation.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.