Kenvueは現在、以下求人を募集しております。
Associate Manager, Clinical Data Management私たちがしていること
私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。
Who We Are
私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。
Role reports to:
Global BioStats, Data Mgmt & Prog場所:
Asia Pacific, India, Karnataka, Bangalore勤務地:
ハイブリッドあなたがすること
Responsibilities will include but not limited to
Plans and manages the design and implementation of Data Management tasks for complex human use research activities to successfully achieve strategic objectives
Ensures all Data Management activities are conducted in accordance with high ethical and quality standards, all applicable GCP regulations and company procedures
Coordinate with Data Management lead in the development of SOPs and other data management standards
Collaborates with other functions such as Clinical and Biostatistics in evaluating and/or implementing opportunities to improve Data Management solutions
Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members with some oversight from senior data management resources
Provides strong quality and project oversight over third party vendor responsible for data management deliverables
Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data)
Enforces data standard conventions and quality expectations for clinical data per defined processes
Contribute to the definition of data structure standards
Authors, reviews/revises DM related study plans including Data Management Plan, Edit Check Specifications, eCRF Completion Guidelines and other study documents to ensure quality and standardization
Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of clinical study data accuracy, quality and completeness
Represents DM on cross-functional project teams & submission teams
Provides support to Health Authority inspections and audits
Represents Data Management on cross-functional project teams
Evaluates proposals from external service providers
Mentor junior professionals for skill set advancement
FSP/CRO/Vendor Oversight: May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
Required Qualifications & Core Competencies
Bachelor’s Degree in Mathematics, Science or a related field required
At least 8 years of clinical data management experience in healthcare related industry
Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
Sound knowledge of all applicable regulations including CFR, GCP, ICH guidelines and industry standard practices regarding data management
Proficiency with Clinical Data Management System required
Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
Strong oral and written communication skills
Communicate effectively with senior management and cross-functional teams
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