Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.

We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress. We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas oncology, immunology and CNS.

Description of the tasks / routine work:

• Assist clinical study team members in preparing, supervising and reporting of clinical trials in accordance with regulatory requirements and relevant standard operating procedures (SOPs)

• Set up and maintain project filing for designated studies (paper and electronic filing systems for records)

• Assist in the preparation, correction, formatting of study-related documents (e.g. Protocol, Patient Information and Informed Consent Form etc.)

• Assist in preparation of presentations for study teams members

• Collect, file and distribute study-related documents (e.g. preparation and maintenance of Trial Master File (TMF))

• Conduct searches for designated feasibility studies

• Assist the study team members in implementation activities where required. Preparation, collection of Regulatory- and Essential Documents, facilitation of IRB/IEC submission and approval process

• Preparation of Investigator Site Files (ISF) e.g. for site initiation

• Set-up and maintenance of tracking systems, reliably and efficiently input data into the tracking systems to facilitate timely access by the study team members, e.g., patients, sites, essential documents, Serious Adverse Events, CRFs and data queries as required for assigned projects

• Participate in project team meetings

• Assist in the preparation of meeting minutes

• Communicate with the study team members and management and to take direction from them as appropriate

• Exert administrative and secretarial functions

• Answer the phone and give information to callers, take messages or transfer calls to appropriate individuals

• Distribute incoming information to appropriate individuals

• Arrange/coordinate appointments, conferences, meetings and events and welcome guest

• Take on any other task as assigned by Manager

• Participate in relevant study/ job-related trainings

Personal skills:

• Ability to work independently
• Professional English language skills
• Effective time management and organizational skills
• Ability to work effectively as part of a team

At Linical, we embrace the opportunities and possibilities that are held by diversity, equal opportunity and inclusion. We value bringing together individuals from diverse backgrounds regardless of race, disability, ethnicity, gender, sexual orientation or any other legally protected characteristic. Linical will consider all candidates that match with the requirements of the position, promoting diversity and equal opportunity for all.