Senior Clinical Trial Associate

**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.

Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe.

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, based on experience and expertise.

**Pharma Resourcing Solutions PRS**

Linical Pharma Resourcing Solutions (Linical PRS) has the experience and a clear understanding of the importance of our clients’ resourcing strategies. With the flexibility that this level of service requires, Linical is able to serve a full range of resourcing requirements as per our clients’ needs and expectations.

Linical PRS is supported by a strong and continuous recruitment activity, accompanied by qualified and highly experienced line management personnel as well as strong leadership oversight throughout the process. Thus, PRS can guarantee success and commitment to the project objectives of our clients.

We truly believe people are the real value of a company and we invest in their performance and their professional satisfaction.

**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
- Coordinate Ethics Committee (central and local) and Competent/Regulatory Authorities submissions (initial and amendments)
- Preparation of Investigator Site Files (ISF) for e.g. 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
- Contract Negotiation Experience
- Answer telephones 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
- Mentoring of new Clinical Trial Assistant
- Provide project specific training to new Clinical Trial Assistant

**Personal skills**:

- Ability to work in a team and independently
- Effective time management and organizational skills
- Communication skills
- Sense of responsibility