Kenvue 目前正在招聘 a:
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在 Kenvue,我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础,植根于科学,是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。
我们是谁
我们的全球团队由 ~ 22,000 名才华横溢的员工组成,他们的职场文化中,每个声音都很重要,每一个贡献都受到赞赏。 我们热衷于洞察, 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心,成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本,热切关怀,以科学赢得信任,以勇气解决——有绝佳的机会等着您!加入我们,塑造我们和您的未来。有关更多信息,请单击 here.
Role reports to:
Global BioStats, Data Mgmt & Prog位置:
Asia Pacific, India, Karnataka, Bangalore工作地点:
混合你会做什么
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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