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Associate Manager, Clinical Data Management

职位职能:
发布日期:
结束日期:
ID:
2607042360W

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Kenvue 目前正在招聘 a:

Associate Manager, Clinical Data Management

我们做什么

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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