Clinical Trial Senior Manager, Operations

3 weeks ago

North Ryde, Australia Macquarie University Full time

PRIMARY DETAIL

•Salary Package: From $133,989 to $141,514 p.a. (HEW Level 9), plus 17% employer's superannuation and annual leave loading
•Appointment Type: Full time, continuing (permanent)
•Macquarie University (Wallumattagal Campus, North Ryde) location

THE ROLE

This newly created role will develop, implement and oversee the delivery of strategic plans for effective resource allocation, professional development and operational excellence of the clinical operations team. By driving strong relationships and process improvements, the successful candidate will ensure optimal patient, investigator, and sponsor experience of clinical trials with the Clinical Trials Unit (CTU). We are seeking someone with extensive management experience at a clinical trial site.

Clinical Trial Managers and the Clinical Trial Laboratory Manager are direct reports, and a large team of Coordinators, Data associates and Lab associates report into those roles.

Reporting to the Head of Clinical Trials Unit, you will be responsible for:

Leadership and Strategy

Set the strategic direction for the clinical trials operations group, and together with the CTU Leadership team, contribute to the CTU overall strategic direction.

Provide strong and consistent leadership that models high performance and an exemplary team culture focused on growth, longevity and continuous improvement.

Develop and implement strategic and operational plans for resourcing clinical trials, ensuring models leverage capabilities and support sustainable growth and the execution of seamless clinical trials.

Clinical Trial Oversight and Resource Management :

Resource Allocation : Develop and implement a sustainable model to effectively allocate Clinical Trials Coordinators to projects ensuring optimal utilisation of resources across trial activities

Trial Support : Provide expert knowledge and collaborate with cross functional teams, sponsors and external stakeholders to oversee and resolve challenges during the course of clinical trials

Skills Assessment : Oversee the assessment of skills, competencies, qualifications and interests of staff, to optimise performance and productivity

Patient Centricity : Drive a culture focusing on the meeting patient needs and conducting trials in such a way as to facilitate diverse patient participation.

Clinical Trial Safety and Data quality: Optimise trial conduct with standards of the highest level of patient safety and data quality.

Performance Metrics: Establish and track key performance indicators related to resource allocation, productivity and trial execution, providing regular updates and insights to senior management.

Communication and Collaboration : Foster effective communication and collaboration to promote a cohesive and results-driven team environment..

People Management:

Develop, lead and manage a high performing team through:

Oversee recruiting and training clinical trial staff to ensure consistency and scalability to meet clinical trial demand

Staff Development : Provide coaching, mentorship and guidance and help with setting meaningful development and career goals to enhance skills and navigate professional challenges 

Managing Performance : Effectively manage individual and team performance and create an environment that motivates team members to perform at their best.

Goal Setting: Assist direct reports in setting clear and achievable performance goals.

Feedback Facilitation: Promote a culture of constructive feedback by encouraging open dialogue, facilitating feedback sessions, and fostering a safe environment for communication.

Recognition and Appreciation : Recognise and celebrate individual and team achievements, fostering a positive and motivated work atmosphere.

Documentation and Reporting: Maintain accurate records of performance discussions, improvement plans, and developmental progress, providing relevant insights to senior management as needed.

Stakeholder Management

Stakeholder management : Identify key stakeholders and build relationships to drive building efficient, safe and exemplary clinical trial conduct. Streamline processes to facilitate MQ being a CT site of choice for clinicians and sponsors.

About You

You will be a strategic thinker and an experienced leader, bringing both your own clinical trial expertise and a proven ability to harness the expertise of others. You will possess a track record of effective resource planning and allocation with a dual focus of supporting, inspiring and developing clinical trial teams to high performance. You will possess a track record of delivering operational excellence to optimise patient, investigator, program manager and sponsor outcomes whilst managing risk, ensuring best practice and a continuous improvement culture. Your focus on delivering outstanding service quality, operational efficiency and financial sustainability will be key to your success.

As the successful candidate, you will possess exceptional communication skills and have successfully built and managed effective collaborations and relationships with a wide range of internal and external stakeholders. You will have strong influencing skills and your experience delivering strategic and operational plans in a growth oriented and fast paced environment will set you up to flourish in this important role.

About Us

The is part of the Faculty of Medicine, Health and Human Sciences (FMHHS) at Macquarie University. FMHHS also has the Macquarie Medical School, the Macquarie University Private Hospital, and runs patient clinics, labs, imaging and a pharmacy all on campus in close proximity to support clinical trials, and support providing patients with access to state of the art treatments. The CTU undertakes sponsored and investigator initiated Phase I to IV trials across multiple therapeutic areas with multiple Principal Investigators. Our current team of over 60 staff (managing over 120 trials) are a close knit inclusive team with a supportive culture that values team work and innovation.

Macquarie is a university engaged with the real and often complex problems and opportunities that define our lives. Since our foundation 54 years ago, we have aspired to be a different type of university. Over the years, we’ve grown to become the centre of a vibrant local and global community. .

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