Site Activation Operations Director - Australia

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What the Site Activation Operations Director does at Worldwide

Is responsible for supporting operational and financial delivery of end-to-end site activation including leading and/or supporting resource management, start-up systems, quality management, process improvement, business and operational metrics, regulatory intelligence and management of assigned Site Activation Assistants

What you will do 

• Supporting the identification, development and adoption of best practices across the Site Activation team. Leading and/or supporting process improvement initiatives as the Site Activation business lead or representative.
• Supporting the identification, development, collation and adoption of departmental business and operational metrics including both key performance indicators and key quality indicators. Liaises with Site Activation business owners to develop relevant metric dashboards.
• Supporting Quality Assurance activities including the review and development of QMDs, coordinating Site Activation support of audits and inspections, coordinating response to QI and serving as CAPA manager as appropriate and representing the Site Activation department on relevant quality governance committees.
• Supporting the identification, development, implementation, deployment and adoption of start-up systems. Serve as the business owner of key systems as requested.
• Supporting the identification, collation and maintenance of clinical trial intelligence. Leading the Regulatory Intelligence Committee and supervising the Regulatory Intelligence assessments and related implementations.
• Supporting sales activities including development of proposal text, case studies, infographics, PowerPoint slides. Representing the Site Activation department during general capability and bid defense meetings as needed.
• Implement the short-term and long-term objectives, major plans and programs of the Site Activation division to ensure they align with and enhance the achievement of corporate strategy and objectives.
• Ensure that authorized plans and programs for the global Site Activation division are properly implemented and that Executive Leadership are informed of the overall trends and conditions of all important activities that impact profitability, market position or stature in the industry.
• Supervise the Site Activation Operations (SA Ops) Assistants team  with the assistance of the Site Activation Operations Lead
• Manage SA Ops resourcing to capacity, interviewing potential SA Ops assistant if necessary, write and conduct performance evaluations for direct reports and ensure training and ongoing development of SA Ops team
• Assist with performance, site and sponsor issues as needed

What you will bring to the role 

• Strong leadership skills
• Excellent planning, strategizing, managing, monitoring, scheduling, and critiquing skills
• Superior written and verbal communication skills to clearly and concisely present information
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Experienced problem solving/decision making skills.
  Good attention to detail.
• Understanding of clinical research principles and process, data collection and editing skills.
• Strong knowledge of FDA regulations, ICH Guidelines
• Understanding of standard operating procedures.
• Knowledge of Word, Excel and Outlook

Your experience

• Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and six years clinical research experience as a clinical research associate OR
• Two-year college curriculum (unless nursing degree then see requirement above) or equivalent education/training and seven years clinical research experience as a clinical research associate OR
• Eight years of clinical research experience as a clinical research associate or other position directly related to clinical research with a CRO, pharmaceutical or
• biotechnology company
• Travel required (passport required)

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.