Data Management Sr Associate

Amgen Inc. (IR); Hyderabad; On-site; INR 8,646,000 - 11,527,000; Full time

Job summary

Amgen Inc. is seeking a Sr Data Management Support to execute data management tasks in clinical trials and support data delivery leads.

You will work on EDC data structures, coding dictionaries and non-CRF data integrations, coordinating with internal and external teams to ensure timely and quality delivery. The role emphasizes collaboration across global teams, maintaining data quality and driving process improvements in a biotech environment.

Qualifications

• Master’s degree or Bachelor’s with clinical execution experience.
• Experience in data management for clinical trials.
• Knowledge of data structures, coding dictionaries and EDCT.
• Experience working with global clinical trials and external partners.

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.
• Setup and maintain EDC/non CRF data structures including local labs and data integrations.
• Track progress against timelines, identify risks, and escalate issues with documentation.
• Coordinate with internal teams, global members and external partners to ensure delivery.

Skills

Data Management

EDC

Global trials

Query management

Data integration

Education

Master’s degree in life sciences

Bachelor’s degree + 2 years clinical execution

Associate’s degree + 6 years clinical execution

High school diploma + 8 years clinical execution

Tools

EDC systems

Coding dictionaries

Job description

Career Category Clinical Development Job Description

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Data Management Support

What you will do

Let’s do this. Let’s change the world.

• 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 escalated 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

Basic Qualifications:

• Master’s degree OR 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

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

What you can expect of us

The annual base salary range for this opportunity in the U.S. is [Talent Acquisition to input market pay range]. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen