Project Manager

**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**:

- The PM will be expected to maintain an in-depth understanding of customer needs within the project group, to focus on achieving the project’s goals and to have knowledge in Oncology.
- Provides/creates a Project Management Plan.
- Implements and updates project specific planning and tracking.
- Implements QC procedures and quality metrics to ensure a high quality standard is maintained throughout the project.
- Maintains current knowledge of SOP’s and regulatory guidance documents which impact the project group.
- Evaluates the project-specific training needs and ensures together with the functional line managers and the Director GCP Training & Compliance Europe that all necessary training is provided to the project staff to ensure high performance and knowledge.
- Management and review of agreements, and their amendments, with third parties involved in the study.
- Preparation of the study Investigator Fee for distribution to the IRB/ECs, PIs,and Sites.
- Ensure that the study is conducted according to the time periods defined by the sponsor, and provides a strategic plan to achieve the required enrollment for the trial/study.
- Participate in the selection of sites and investigators for the trial/study, and verifies that investigators possess adequate qualifications and resources throughout the trial.
- Furthermore, verifies that the facilities, including laboratories, equipment and personnel, are adequate for a safe and correct execution of the trial throughout the study.
- Review and coordinates the execution of agreements with participating sites.
- Control the overall budget of the study and payments to involved parties.
- Creation and regular review of FTEs assigned to the study.
- Preparation of the material required for training of Investigators and
site personnel during Investigator Meetings and/or Initiation Visits.
- Coordinate the preparation and planning of Investigator Meetings, if any.
- Ensuring compliance with the Monitoring Plan, and the review of monitoring
reports according to the corresponding SOP.
- Ensure that the transfer of sites between monitors is adequately executed.
- Ensure that the findings and protocol deviations are managed according to the
GCP_ICH and the applicable legislation, as well as adopt corrective and
preventive measures.
- Notify and inform to the Medical Coordinator and Medical Monitor about
major protocol deviations.
- Ensure that SAEs and SUSARs are notified according to the local legislation, the
protocol, and the GCP_ICH.