Associate Manager, Clinical Data Management
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What you'll do
- 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
What they're looking for
- 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
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Kenvue is currently recruiting for a:
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 ManagementLocation:
Asia Pacific, India, Karnataka, BangaloreWork Location:
HybridWhat 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
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Company
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