Associate Manager, Clinical Data Management

Associate Manager, Clinical Data Management

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

Global BioStats, Data Mgmt & Prog

Местонахождение:

Asia Pacific, India, Karnataka, Bangalore

Место работы:

Гибрид

Что ты будешь делать

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

Если вы являетесь человеком с ограниченными возможностями, пожалуйста, ознакомьтесь с нашим страница помощи инвалидам для получения информации о том, как запросить приспособление.