Manager, Clinical Operations.Japan
Tokyo, Japan
‎‎9 時間前

Position Summary :

This position will be responsible for hiring, training and retaining qualified Clinical Research Associates (CRAs) and resource allocation to study teams.

This position is accountable for the performance the CRAs and assures that quality of services meets internal and external customer requirements.

The CRA Manager must also exercise judgment in planning and organizing work; monitor performance and report status, sets goals, and ensure that they are met while being responsible for continuous process improvement.

Essential Functions :

Responsible for hiring, training and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development.

Accountable for the development of direct reports through performance reviews, instruction, mentoring, and coaching. Accountable for the performance and work output of direct reports.

Sets goals which align with study team goals. Assigns appropriate clinical personnel to clinical studies. Models optimum leadership competencies to inspire an energized, empowered, and accountable work force, ethical behavior, favorable community image, and actualization of the SJM Core Values.

Contributes to global process improvement teams. Utilize the CRA Activity Dashboard to track CRA work output. Ensure new hires are trained in SJM policies and procedures, Clinical Data Systems, Clinical Process / Procedures and Study specific topics.

Ensure that CRAs are updated and advised on new or changed processes, procedures, and policies. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, and contractors.

Other Duties : List any other important but non-essential and / or infrequent duties performed.

Develops an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies.

Provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work Instruction (DWIs). May make additional contributions as assigned.

Equipment : List the type of equipment the incumbent in this position is required to work with.

Uses standard office equipment, including (but not limited to) personal computer, telephone, FAX, and copier.

Working Conditions : Describe the work environment characteristics representative of those encountered by an employee performing the essential functions of this job.

Normally works in a cubicle situated in open landscape office environment. Air conditioned. Well lighted. Moderate noise level.

Physical Demands : Describe the physical demands representative of those that must be met by an employee to successfully perform the essential functions of this job.

Primarily sitting. Some walking. Light effort related to moving, lifting and using office supplies and standard office items.

Performs tasks which regularly require good correctable vision and hand / eye coordination.

This position may require up to approximately 10% travel.

Qualifications :

Required : A Bachelor degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.

Minimum seven years clinical research experience.

Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem solving skills.

Able to meet deadlines and work effectively with all levels of employees.

Proficiency in Microsoft Office Suite and relevant clinical applications.

The ability to work independently when necessary.

Desired : Advanced degree preferred with an academic focus in natural science, nursing, bioengineering or a related academic field.

An excellent understanding of all aspects of clinical research. A general familiarity with cardiac, vascular, and / or neuromodulation technologies.

Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical / hospital environment.

Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).

Work habits include organization, coordination of many tasks, accuracy, and attention to detail.


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