Data Management Sr Associate

Amgen Technology; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Amgen is seeking a Sr Data Management Support to help deliver high-quality clinical trial data across the study lifecycle. You will ensure data integrity, compliance, and timely study execution through core data management activities.

You will work with Data Delivery Leads and Datasets, set up EDC and non-CRF structures, track timelines, escalate risks, and collaborate with local and global partners to drive study success.

Qualifications

• Bachelor's degree with 6 years of clinical execution experience.
• 3 years' work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience.
• Experience working in Data Management on global clinical trials.

Responsibilities

• Execute study data management tasks including database build testing, data cleaning, query management, reconciliation, and lock preparation.
• Support core Data Management roles by owning time-sensitive deliverables with high-quality execution.
• Set up and maintain EDC/non-CRF data structures including local labs and coding dictionaries.
• Track timelines, identify risks, and document mitigations.
• Coordinate with internal and external partners to ensure aligned delivery of study activities.
• Identify opportunities to improve repeatable processes and share knowledge.

Skills

Data management

Study lifecycle understanding

Education

Bachelor's degree

Tools

EDC systems

Data dictionaries

Job description

Job Summary

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

w\\eve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Role

Sr Data Management Support

What you will do

Lets do this. Lets change the world. In this vital role you will support the delivery of high-quality clinical trial data by executing core data management activities across the study lifecycle, ensuring data integrity, compliance, and timely study execution.

• 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 escalation 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 expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.

Basic Qualifications

• Bachelors degree with 6 years of clinical execution experience

Preferred Qualifications

• 3 years' work experience in life sciences or medically related field, including 1 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience working in Data Management on global clinical trials