Sr Associate Clinical Master Data Management Job at Amgen (Hyderabad)

Sr Associate Clinical Master Data Management

The Master Data Analyst at Amgen will support the accuracy and consistency of ma...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a STEM discipline and 5 years of experience in SAP ECC, clinical master data management, data governance, or data operations, preferably in the healthcare or biotech supply chains
Experience in SAP/Oracle, Microsoft Office (Excel, PowerPoint), and other data management tools (e.g., Informatica, Oracle MDM)
Strong ability to analyze large datasets and deliver actionable insights
Skilled at identifying root causes of data issues and implementing effective solutions
High accuracy and attention to detail, with a strong focus on data quality
Excellent written and verbal communication skills, with the ability to present findings to both technical and non-technical stakeholders
Working knowledge of SAP/Oracle
Understanding of master data management processes, frameworks, and governance
Proficiency in Excel and MS Office Suite, with experience in data analysis
Basic understanding of data governance frameworks and ensuring data accuracy and quality

Job Responsibility

Perform data operations tasks, mainly maintenance, and validation, to ensure the accuracy and integrity of master data
Follow Principles of Handling and Access to Restricted Data for Clinical master data
Initiation and maintenance of the study integrity document (SID) for Clinical master data
Support process optimization initiatives to improve data management workflows and enhance efficiency
Conduct data analysis to identify trends, discrepancies, and opportunities for improvement
Provide training and support to partners, customers, and end-users on master data processes, tools, and best practices
Maintain data quality reports to monitor performance metrics and ensure data compliance
Collaborate cross-functionally with business, IT, and operations teams to resolve data-related issues and ensure alignment with organizational goals

Fulltime

Sr. Data Associate, Data Management Science

The Senior Data Associate supports the Clinical Program and acts as the GDS DMS ...

Location

United States , San Rafael or Brisbane

Salary:

96000.00 - 144000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

MA degree preferred, or BA/BS degree with a focus in statistics, computer science, life science, or related scientific discipline
2+ years of experience in clinical development, including technical experience within and outside of Data Management, with MS
5+ years with BS
Decision Making, Critical thinking and Problem Solving
Influence, Cross-Functional Collaboration and Organizational Awareness
Agility and Proactivity
Leadership
Communication
Strategic Thinking and Planning
Operations

Job Responsibility

Draft Case Report Form (eCRF) in a concise, self-explanatory, and user-friendly format
Draft Data Management Plan outlining key Data Management activities and deliverables
Collaborate with Clinical Programming and Data Quality Science and facilitate the completion of the Data Validation Plan
Conduct appropriate ongoing/periodic data validation activities
Draft data transfer specifications
Conduct SAE reconciliation activities
Maintain data transfer calendar requirements
Post listings/reports/profiles to study file locations
Reconcile external data
Maintain and track timeline, discrepancies, query resolution, and deliverable status

What we offer

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

Data Management Sr Associate

At Amgen, if you feel like you're part of something bigger, it's because you are...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree
Bachelor's degree and 2 years of clinical execution experience
Associate's degree and 6 years of clinical execution experience
High school diploma / GED and 8 years of clinical execution experience

Job Responsibility

Execute study data management tasks including database build testing, data cleaning, query management, reconciliation, and lock preparation with limited oversight
Support core Data Management roles, such as Data Delivery Leads, Database Designers, and Data Acquisition Leads by owning time-sensitive deliverables with high-quality execution
Actively contribute to setup and maintenance of EDC/non CRF data structures including local labs, coding dictionaries, along with non-CRF data integrations
Track progress against data management timelines, study timelines and deliverables, identify risks or delays, and escalate issues with clear documentation and any mitigations
Coordinate with local internal teams, global team members as well as external partners (including FSPs) when required to ensure aligned and efficient delivery of all study activities
Identify opportunities to improve repeatable processes and contribute to best practices and knowledge sharing across the team

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Sr Associate Clinical Supply Chain Support Office

In this vital role, you will serve as Sr Associate, supporting the Design and Se...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

5+ Years of experience with Bachelors degree or equivalent in logistics, business administration or life science
Typically relevant working experience, preferably in the biotechnology or pharmaceutical industry
Typically relevant working experience in an international and regulated environment
Understanding of fundamentals of logistics/supply chain principles (especially BOM)
Experience in planning
Experience in project management techniques
Advanced experience in MS Office applications (Word, Excel)
Fluency in English, both in oral and written communication
High quality standards with regards to work
Ability to set priorities and timely escalation

Job Responsibility

Serve as Sr Associate, supporting the Design and Setup of the Clinical Supply Chain
Managing master data requests for product materials, Bill of Materials (BOM), and study related attributes in SAP
Creation of the Clinical Artwork requests and facilitating prioritization of outstanding attributes in relation to the request form
Creation and maintenance of Product Specification Files, and Depot Plans
Coordinate and prioritize artwork creation process via initiation and routing of clinical artwork creation request forms
Creates and maintains Product Specification File Study throughout the life cycle of the clinical trial
Creates and maintains third party depot plans and cross docks to support global study footprint
Maintains Metrics for Global Setup lead team
Contributes to monthly Workforce planning cycle

Fulltime

Sr Associate Clinical Supply Chain Support Office

In this vital role, you will serve as Sr Associate, supporting the Design and Se...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

5 Years of experience with Bachelor degree or equivalent in logistics, business administration or life science
Typically relevant working experience, preferably in the biotechnology or pharmaceutical industry
Typically relevant working experience in an international and regulated environment
Understanding of fundamentals of logistics/supply chain principles (especially BOM)
Experience in planning
Experience in project management techniques
Advanced experience in MS Office applications (Word, Excel)
Fluency in English, both in oral and written communication
High quality standards with regards to work
Ability to set priorities and timely escalation

Job Responsibility

Master Data in ERP (SAP)
Initiate clinical label material requests
Requesting Finished Drug Product Materials, Bill of Materials (BOM), Work Breakdown Structure (WBS) elements, Custom Values and ensures timely availability to adhere to overall project timelines
Ensures setup of Study Design Tables
Coordinate and prioritize artwork creation process via initiation and routing of clinical artwork creation request forms, facilitating discussions to resolve issues and following up on outstanding queries
Creates and maintains Product Specification File Study throughout the life cycle of the clinical trial
Creates and maintains third party depot plans and cross docks to support global study footprint
Maintains Metrics for Global Setup lead team
Contributes to monthly Workforce planning cycle

Fulltime

In-house Sr Clinical Research Associate

A clinical-stage biopharmaceutical company in San Diego, California is seeking a...

Location

United States , San Diego

Salary:

60.00 - 75.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor degree preferred
3 years of CRA experience
Site management and CRO/vendor oversight
Proficiency with Microsoft Office and Veeva eTMF required
Phase I–III Experience

Job Responsibility

Support clinical operations across multiple studies while ensuring subject safety and data integrity
Review and maintain the electronic Trial Master File (eTMF) in compliance with SOPs, GCP, and ICH guidelines
Support study start-up and ongoing trial activities, including regulatory documentation and site readiness
Serve as a liaison between internal teams, CROs, vendors, and investigator sites
Review monitoring visit reports (PSV, SIV, IMV, COV)
Remotely track enrollment and treatment status using IxRS and EDC systems
Maintain study tracking tools, meeting minutes, and action items
Participate in investigator meetings, study training, and co-monitoring activities as needed
Perform duties in compliance with FDA regulations, ICH-GCP, and company policies

What we offer

Medical
dental
vision
401(k)
telehealth services
ESOP
commuter benefits

Fulltime

Study Delivery Sr Associate

The Study Delivery Senior Associate provides essential global study management s...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree OR Bachelor's degree and 2 years of clinical execution experience OR Associate's degree and 6 years of clinical execution experience OR High school diploma / GED and 8 years of clinical execution experience
3 years' work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience working on global clinical trials
Strong collaborative and effective communication skills within a team environment
Understands importance of accuracy in documentation, data tracking, and compliance checks
Identifies discrepancies and escalates appropriately
Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
Ability to maintain accurate and timely data entry

Job Responsibility

Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility
Coordinate logistics for investigator meetings, trial events, and site communications
Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards
Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks
Lead delivery of assigned risk and quality management activities
Track and report study progress, coordinating with Study team and vendors to resolve operational issues and maintain compliance
Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved
Manage Study Training system activities and oversight
Build and maintain effective relationships with internal study team members, vendors and investigator sites
Act as a point of contact for routine study updates, ensuring stakeholders are informed and aligned

Sr. Associate IS Engineer

The IS Engineeris responsible for designing, developing, and maintaining softwar...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree and 3 to 7 years of Computer Science, IT or related field experience
Bachelor’s degree and 5 to 9 years of Computer Science, IT or related field experience
Diploma and 7 to 9 years of Computer Science, IT or related field experience
Hands on experience with Veeva Vault configuration
Proficiency in programming languages such as Python, JavaScript preferred or other programming languages
Strong understanding of software development methodologies, including Agile and Scrum
Solid understanding & Proficient in writing SQL queries

Job Responsibility

Possesses strong rapid prototyping skills and can quickly translate concepts into working code
Lead day to day operations and maintenance of Veeva Clinical Operations vault applications
Stay updated with the latest trends, advancements and standard process for Veeva Clinical Operations Vault applications
Design, develop, and implement applications and modules, including custom reports, interfaces, and enhancements
Analyze and understand the functional and technical requirements of Veeva Clinical Operations Vault applications, solutions and systems and translate them into software architecture and design specifications
Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software following IS change control and GxP Validation process
Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time
Maintain detailed documentation of software designs, code, and development processes
Work on integrating with other systems and platforms to ensure seamless data flow and functionality
Stay up to date on Veeva Vault Features, new releases and best practices

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Sr Associate Clinical Master Data Management

Job Description

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