About the Company
KlinEra Global Services is a global Clinical Research Organization (CRO) providing comprehensive clinical research and development services to pharmaceutical, biotechnology, and healthcare organizations. We are committed to delivering high-quality clinical research solutions while maintaining the highest standards of scientific integrity, patient safety, regulatory compliance, and operational excellence.
We are seeking an experienced and motivated Clinical Research & Development Manager to join our team in Brisbane, Australia. The successful candidate will be responsible for leading clinical research and development initiatives, managing complex clinical research projects, and collaborating with cross-functional teams and sponsors to ensure successful study delivery.
Job Summary
The Clinical Research & Development Manager will be responsible for developing, implementing, and monitoring research and development strategies aligned with organizational and sponsor objectives. The role will provide strategic and operational leadership across major clinical research projects, from study start-up through close-out.
The position will work closely with internal and external stakeholders to ensure projects are delivered in accordance with approved protocols, timelines, budgets, applicable regulatory requirements, ICH-GCP guidelines, and company SOPs.
Key Responsibilities
- Determine, implement, and monitor research and development strategies, policies, and plans aligned with organizational and sponsor objectives.
- Develop and implement research projects, priorities, and targets to support commercial and strategic objectives.
- Lead major clinical research projects from study start-up through close-out, coordinating the activities of Clinical Research Associates (CRAs), Research Associates, and other research staff.
- Assess the benefits, costs, and effectiveness of research and development activities and manage project budgets against defined milestones and timelines.
- Interpret research findings and recommend opportunities for product, service, and process development based on study outcomes.
- Provide strategic advice on research and development opportunities, supporting proposal development, feasibility assessments, and sponsor presentations.
- Monitor emerging trends and leading-edge developments in clinical research and assess their implications for organizational strategy and study design.
- Publish or present significant research findings where applicable and contribute to scientific and operational knowledge-sharing.
- Oversee study protocols, clinical documents, project plans, and study deliverables, ensuring compliance with ICH-GCP, applicable regulatory requirements, and company SOPs.
- Identify project risks, assess their potential impact, and implement appropriate mitigation and contingency strategies.
- Collaborate with Clinical Operations, Medical Writing, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Quality Assurance, and Business Development teams to ensure integrated project delivery.
- Manage and develop research teams by supporting recruitment, assigning responsibilities, delegating tasks, and conducting performance assessments.
- Provide coaching, mentoring, and professional development opportunities to team members.
- Manage project budgets and resources, ensuring financial objectives are achieved while maintaining study quality and timelines.
- Monitor study progress, key performance indicators, milestones, and deliverables and provide regular updates to senior management and sponsors.
- Ensure all research and development activities are conducted in accordance with applicable safety standards, ICH-GCP guidelines, ethical principles, and relevant regulatory legislation.
- Promote a culture of quality, compliance, accountability, and continuous improvement across research and development activities.
Required Qualifications & Experience
- Bachelor's or Master's degree in Life Sciences, Clinical Research, Pharmacy, Medicine, or a related discipline.
- Significant experience in clinical research and development, preferably within a CRO, pharmaceutical, biotechnology, or healthcare organization.
- Demonstrated experience managing clinical research projects from study start-up through close-out.
- Proven experience in clinical project management, team leadership, and stakeholder management.
- Strong knowledge of ICH-GCP principles and applicable clinical research regulations and guidelines.
- Experience managing project budgets, timelines, resources, risks, and deliverables.
- Experience working with cross-functional teams across clinical operations and other clinical research functions.
- Strong understanding of clinical trial processes, study protocols, essential documents, and quality management principles.
- Experience in sponsor communication, proposal development, feasibility assessments, and project presentations will be highly regarded.
- Experience working within the Australian clinical research and regulatory environment will be an advantage.
Skills & Competencies
- Strong clinical research and project management skills.
- Excellent leadership and people management capabilities.
- Strong strategic thinking and problem-solving abilities.
- Excellent written and verbal communication skills.
- Strong stakeholder and sponsor relationship management skills.
- Ability to manage multiple projects, priorities, and deadlines effectively.
- Strong understanding of risk management and quality management principles.
- Excellent analytical and decision-making skills.
- Ability to interpret clinical research data and translate findings into actionable recommendations.
- Strong attention to detail and commitment to quality and compliance.
- Ability to work collaboratively in a cross-functional and multicultural environment.
- Proficiency in Microsoft Office and relevant clinical research/project management systems.
What We Offer
- Opportunity to work with a growing global Clinical Research Organization.
- Exposure to international clinical research projects and global sponsors.
- Collaborative and inclusive working environment.
- Opportunities for professional growth and career development.
- Exposure to cross-functional clinical research and development activities.
- Opportunity to contribute to innovative clinical research and healthcare initiatives.
- Competitive remuneration package commensurate with qualifications and experience.
How to Apply
If you are an experienced clinical research professional looking for an opportunity to contribute to high-quality clinical research and lead strategic research and development initiatives, we would like to hear from you.
Please submit your updated CV/resume along with a brief cover letter outlining your relevant experience and suitability for the position.
Pay: From $80,000.00 per year
Work Location: In person
