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Director of Clinical Operations
2 months ago
InClin, a boutique Contract Research Organization (CRO) with offices in the US and Australia, is seeking a highly skilled and experienced professional to join our Australian office as an Associate Director, Clinical Operations.
Key Responsibilities- Provide operational and implementation expertise to the Clinical Operations Department and report directly to the Vice President of Clinical Operations.
- Serve as Project Director or Project Manager/Lead Clinical Research Associate (CRA) for InClin project teams.
- Operate at a strategic level, including input into risk management plans, department process improvements, and therapeutic area/indication expertise.
- Provide guidance and mentorship to Clinical Staff as appropriate on specific activities and approaches to execute work.
- Contribute to the development of critical plans, including scenario planning, high-level forecasting of timelines, estimation of resources and budget, and development of operational strategies.
- Handle unique challenges and decisions that have an impact on Clinical Operations.
- Provide innovative and flexible operational solutions.
- Maintain internal consistency across clinical operations teams.
- Collaborate effectively with internal and external partners.
- Participate in the development of clinical operations performance standards.
- Participate in the selection, onboarding, and line management of Clinical Operations staff.
- BA/BS or Advanced degree (Masters/PhD) in the sciences.
- Highly advanced knowledge of the Clinical development process.
- At least 12 years of relevant clinical Pharmaceutical, Biotechnology, Device, or CRO experience.
- 5 years of direct Line management experience.
- Prior site experience considered beneficial for either CRA-Field monitoring or CRC.
- Prior CRO experience preferred.
- Experience in execution of complex clinical trials ranging from Phase 1 studies to large multi-center global programs.
- Well-versed in GCP and applicable FDA/EMA regulations required.
- Ability to present clinical trial and departmental updates to senior management.
- Ability to manage client relationships.
- Able to incorporate a broad understanding of industry issues into plans/strategies to capitalize on ideas and initiatives that will drive the success of the Clinical Operations department now and in the future.
- Able to consider how present policies and practices might be affected by future developments and trends within the global regulatory and compliance landscape.
- Effective in building relationships and networks across and beyond InClin.
- Able to compile, analyze, and present data in a concise manner, in both written and oral context.
- Demonstrate ability to enlist input from stakeholders to make key decisions (e.g. tactics to accomplish goals), while ensuring final decisions are reached quickly and effectively.
- Able to provide both performance feedback to direct reports and staff who may report to others.
- Able to identify development opportunities for Clinical Operations staff.
- Comfortable stretching people to help them grow.
- Outstanding verbal and written communication and interpersonal skills.
- Dynamic presentation skills, including command of the English language.
- Ability to effectively work under pressure within tight timelines.
- Strong computer skills (MS Office and project planning software).
- Ability to travel as required (~25%).
