Senior Clinical Research Associate||シニアCRA

Company overview: top 4 oporthopedic copmany focused in: sports medicine, extremities, trauma, spine, dental implants, and related surgical products. The Company's products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues.

Job Summary
This position is responsible for managing all facets of clinical research to gather the required clinical evidence to support the registration of products in Japan as well as the marketing of the products after approval. The entrant should have at least 5 years of experience in conducting clinical research in Japan. This position will participate in clinical strategy formulation, prioritize project initiatives and execute agreed project plan to acquiring the clinical data to meet the business needs.

Responsibilities will include clinical study project management, site management that include monitoring, study set up, CRO management, coordination of statistical analysis and publication. Clinical study development responsibilities include literature research, protocol drafting, case report form design and budgeting. This position focuses on subject matter expertise and is not responsible for personnel management. The position is also expected to coordinate clinical evaluation report projects in Japan.


Principal Duties and Responsibilities

35%: Clinical study development responsibilities include literature research, protocol composition, case report form development, and recommendations for investigators. Develops project budgets and needs assessments such as monthly & annual budgets as well as annual needs assessments. Consults with biostatistician and internal reviewers in formulating the clinical study plan. Discuss with stakeholders and obtain the necessary approval from relevant review committees on clinical projects. For clinical trials required for product registration, collaborate with Regulatory Affairs and other relevant departments to formulate the appropriate clinical trials.


35%:Perform site qualification, initiation and monitoring. Conducts or oversees clinical site visits including site selection to ascertain potential investigator interest and feasibility to participate in a study, site initiation and training as well as general oversight to evaluate the performance/compliance levels of site and take appropriate action necessary to resolve any issues of noncompliance. Review and manage study payments and reimbursements. Coordinates and facilitates development of peer-reviewed manuscripts and reports on data received.


10%: Contribute to clinical research strategy development to obtain the required clinical evidence to support the business needs. Participate in the clinical research strategy formulation with stakeholders. Lead and communicate clinical strategic initiatives as required. Conduct routine review with stakeholders to update on project status and obtain feedback to refine the initiatives.


10%: Review and provide input to improve clinical operations efficiency. Implement and track relevant key performance indicators to assess the performance of clinical operations and ensure the deliverables from the clinical projects are met in accordance to the agreed plan.


5%Serves as a clinical research liaison for investigator-initiated studies. Communicate with requestors professionally and in a timely manner. Prepares and routes funding applications or in-kind requests in compliance with established SOPs and policies of the company.


5%: Coordinate clinical evaluation report project to support product registration. Facilitate CRO proposal review and related processes such as selection, due diligence and contract. Monitor the progress of CRO services and deliverables.







Expected Areas of Competence:


Demonstrates ability to effectively communicate ideas and persuade others to accomplish goals and objectives.
Sets priorities consistent with company goals and focuses on high priority opportunities.
Allocates resources (e.g. time, dollars) consistent with priorities.
Takes steps to understand external and internal stakeholders’ needs and translate this knowledge into effective decisions.
Drives innovation through embracing diversity and change.
Delivers results and drives for continuous improvement. Has high performance expectations and holds others accountable for results. Takes action to enhance performance based on experiences and feedback.
Demonstrates principled leadership and sound business ethics; shows consistency among principles, values and behaviors.
Encourages and supports information sharing and collaboration across departments.
Demonstrates proficiency in writing clinical study protocols and designing case report forms.
Demonstrates teamwork and ability to train/coach colleagues in study management issues.
Possess outstanding organizational skills and attention to detail.
Proficient in the command of English, both verbal and written. Highly proficient in the command of Japanese, both verbal and written.


Education/ Experience Requirements


A bachelor’s degree in the health, life sciences, or engineering disciplines. Masters Degree Preferred
Minimum of 5 years experience in clinical research (preferably in device trials/studies) in Japan including clinical study project management.
Thorough knowledge of international guidelines and local regulations in the conduct of clinical research especially in medical devices.
Excellent knowledge in clinical research methodology and processes from the set up to completion phase of clinical research projects.
Good technical knowledge in the field of orthopedics and orthopedic implants is advantageous.

Travel Requirements


Domestic travel ~50%.

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