Site Activation Specialist - Japan - Remote at Worldwide… · Tokyo

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 department does at Worldwide

As a Site Activation Specialist, you will be an integral part of our Site team, collaborating seamlessly to facilitate the efficient activation of clinical research sites. Discover a world of difference at Worldwide, where we nurture your career development and growth.

With a focus on honing project management and strategic planning skills, our team supports you in advancing through the opportunities within Site Activation and sets you up for success to progress forward to Project Management or other Clinical Operations groups.

What you will do

• Track study-specific site regulatory documents by site and/or country and follow up with sites or internal team members
• Support the development, adaptation, and review of country/site specific informed consent forms
• Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
• Collect, receive, and perform first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and relevant study specific plans
• Provide local follow up and updates of status of local EC submissions to the relevant teams assigned to the project
• Support Site Identification activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Site Feasibility Questionnaires

What you will bring to the role

• Organizational and time management skills
• Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills
• Strong ability to handle multiple tasks in a fast-paced and changing environment
• Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Strong understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel

Your experience

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
• Minimum one year of experience in clinical research, preferably in site activation or regulatory-related function
• Previous experience within the pharmaceutical/CRO industry
• Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance
• Multilingualism preferred; fluent in local language; working knowledge of English

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 http://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**.**