Associate Manager, Clinical Data Management

Associate Manager, Clinical Data Management

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Manager, Clinical Data Management

Location:

Asia Pacific, India, Karnataka, Bangalore

Work Location:

Hybrid

What you will do

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

• 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

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.