臨床試験のデータ管理部門シニアアソシエイト at Alcon

Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

医療機器, 医薬品, 臨床試験Industries

Requirements

English skills sufficient for creating materials and presenting in meetings
Programming experience using SAS, R, or other languages (5+ years)
Experience with PMDA application processes handling electronic deliverables such as CDISC and EDC (5+ years)
Knowledge of PMDA regulations and guidelines regarding electronic deliverables
Understanding and technical skills in databases and programming
Flexible communication skills to convey information to other departments

Responsibilities

Quality management of clinical trial databases and statistical analysis tables
Creation, organization, and preparation of various application materials for PMDA written inquiries related to clinical trial data management and statistical analysis
Conducting data checks using programs, creating listings, etc., for application preparation
Management of CRO operations
Collaboration with global teams on the above tasks
Creation and organization of written inquiry submission materials and internal documents for regulatory applications related to medical devices and pharmaceuticals
Collaboration with development-related departments
Participation from the planning stage of application projects, providing advice and input on schedules and costs from the department's perspective
Primarily programming-related tasks initially, with future leadership of the Clinical Biometrics department

Skills

Key technologies and capabilities for this role

SASRCDISCEDCPMDAデータベースプログラミング統計解析データチェック

Questions & Answers

Common questions about this position

What programming skills are required for this role?

Candidates need 5+ years of programming experience using SAS, R, or other languages (to be discussed). Proficiency in programming is essential for data checks and creating listings.

What prior experience is necessary for this position?

5+ years of experience handling electronic deliverables like CDISC and EDC for PMDA application processes is required, along with knowledge of PMDA regulations and guidelines for electronic deliverables.

What English proficiency is needed?

English skills at a level sufficient for creating materials and presenting in meetings are required.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What are the career growth opportunities in this role?

The role starts with programming-related tasks but offers the opportunity to eventually lead the Clinical Biometrics department.

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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