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Senior Specialist – Clinical Affairs

Smith+NephewTokyo, JPN

30+日前

職務内容の詳細

Description

Key Responsibilities and Accountabilities

Job Purpose :

Contribute to new product approval, expansion of market adoption, and maintenance of product access through the generation and evaluation of clinical evidence. Ensure adherence to Good Clinical Practices, applicable laws and regulations, standard operating procedures, Smith and Nephew Code of Conduct in accordance with established budgets and timelines.

Job Context :

Within an environment of rapidly changing technologies, and the increased need to generate evidence on the performance of our products, the jobholder executes a wide range of clinical affairs projects and acts as a clinical research expert, working with Global Clinical Strategy (GCS) and wider Global Clinical & Medical Affairs (GCMA), as well as the broader Franchise team stakeholders.

The key challenges are to :

cover a wide range of clinical work related to the planning, implementation and management of all types of clinical studies (excluding specific tasks such as data management, statistical analysis and audit), the clinical part of product registration, as well as the improvement of infrastructure for clinical projects
ensure appropriate project planning and acting as clinical research expert to ensure project milestone delivery
to deliver projects to plan, mitigating risks and forward planning to limit delays to project execution and to ensure project quality

Dimensions (Relevant facts and figures relating to job)

General : The jobholder has a broad exposure across the franchise and also works with other parts of the Smith & Nephew business. The timely conduct of clinical studies to the desired standard is critical to the business, playing a key role in post market surveillance, new product launches, market access and secured product access and claims transfer.

Clinical projects : The jobholder may be in charge of all types of clinical studies (including pre- / post-market clinical trials, post-market surveillance and post-market clinical studies), the clinical part of product registration and the improvement of infrastructure for clinical projects.

The percentage of work associated with each responsibility will vary depending on the project and team situation.

The proportion of work related to each responsibility will vary depending on the project and team situation. Job holders may be responsible for the following tasks :

Implementation of Smith & Nephew Initiated Study (SNIS) : Depending on the nature of the project, the jobholder will implement the roles of Clinical Study Management (CSM), Study Site Management (SSM), Clinical Research Associate (CRA), Clinical Operations, and Strategy Lead / Specialist in Japan, either in collaboration with the global teams or by using outsourcing.

Clinical part of product registration (regulatory submission) that includes preparation of Clinical Study Report, foreign data submission, preparation of Clinical Evaluation Report (CER), preparation of STED and PMDA consultation.

Creation and maintenance of SOPs.

Other work related to Clinical Affairs

Bachelor of Science (Life science or related field) or equivalent. Master of Science are desirable.

Competencies :

Autonomy / Initiative

Adaptability & Flexibility

Discipline

Creative & Innovative Thinking

Communication

Experience :

Experience in clinical development in the medical device / pharmaceutical / biotechnology industries. Experience in medical devices is strongly preferred.

Practical and theoretical knowledge of applicable laws and regulations (GCP, ISO 14155, etc.)

Proficiency in Microsoft products

Proficiency in Medidata / Veeva Vault is preferred.

Project management and documentation skills are preferred.

Business-level English proficiency is preferred.

Experience in orthopedics or wound management is preferred.

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Senior Specialist • Tokyo, JPN