Data Acquisition Leader - eConsent

Amgen Inc. (IR); Telangana; Hybrid; INR 2,500,000 - 4,200,000; Full time

Benefits offered by this job

Total rewards plan

Remote work arrangements

Job summary

Amgen Inc. (IR) is seeking a Data Acquisition Lead focused on eConsent to own the setup, integration and ongoing management of non-CRF data systems. You will ensure data quality, traceability, and alignment with study protocols across internal teams and external partners.

The role requires 5+ years in life sciences with experience in clinical data delivery, system integrations, and regulatory compliance. Hybrid work options and a strong collaboration culture are offered.

Qualifications

• 5-12+ years in life sciences or biopharma data management and clinical systems.
• Experience with external suppliers (eConsent, CROs, labs) and data acquisition.
• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Strong documentation, communication, and cross-functional collaboration.

Responsibilities

• Own design, setup, and ongoing management of non-CRF data and systems (eConsent and related data).
• Align system requirements with study protocol and eConsent requirements.
• Oversee data transfers, interfaces, and data quality across external partners.
• Triage data issues, lead reconciliation, and ensure data traceability across platforms.
• Coordinate with global study teams and external vendors to meet regulatory standards.
• Lead testing, deployment, and change control for systems and integrations.

Skills

Clinical systems

Data acquisition

Vendor management

Project management

Regulatory compliance

Education

Doctorate/Master/Bachelor with 8-12 yrs experience

Job description

Career Category Clinical 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.

Data Acquisition Lead - eConsent

What you do

• Own the design, setup, and ongoing management of non-CRF data and/or systems as assigned by management (e.g., central labs, imaging, wearables, precision medicine, IRT, eCOA, eConsent), ensuring seamless integration and traceability
• Alignment of system requirements, setup and lifecycle activities with study protocol and eConsent requirements
• Own, define and maintain supplier data transfer and/or system specifications, oversee system and data transfer agreements to ensure alignment to study requirements and study protocol including associated data flows, as applicable
• Ensure timely and accurate ingestion of external datasets, proactively resolving formatting, mapping, and data quality issues – own query resolution with data including issue escalation with study team and/or suppliers including reconciliation and resolution of eConsent-related data or integration discrepancies, as applicable
• Partner with other Data Management roles, Clinical Systems partners, external service providers, and the study team (global/local) to ensure external systems and data align with study protocol, regulatory requirements and Clinical Trial Database CRF structures, and data is accessible within EDC or other data platforms for downstream processes including data cleaning and archival including and traceability of eConsent systems and associated data
• Lead troubleshooting of supplier system and/or integration issues, including delayed or inconsistent data deliveries, missing data and escal issues and systemic risks as needed including eConsent system, configuration, data flow
• Monitor the quality of system documentation and/or incoming data throughout the study lifecycle and initiate early reconciliation to prevent downstream delays or risks to inspection readiness – ensure we are ‘data delivery/analysis’ ready at all times including monitoring eConsent system/data quality, traceability, and reconciliation, as applicable
• Support the internal team by managing task or project-related timelines against study milestone targets to ensure no impact to system lifecycle activities or other deliverables including eConsent setup, updates, and study amendment-related activities
• Work with internal or external resources to manage the creation and execution of user acceptance testing, deployment, and change control activities for systems and/or integrations

What we expect of you

Basic Qualifications

• Doctorate degree OR Master’s degree OR Bachelor’s degree with 8 - 12 yrs experience.

Preferred Qualifications

• 5 years’ work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience responsible for clinical systems and/or data acquisition delivery on clinical trials in a biotech, pharmaceutical or CRO / supplier company
• Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
• Experience in management and oversight of external suppliers (e.g., eConsent, CROs, central labs, imaging, IRT, eCOA, etc.)
• Knowledgeable in Good Clinical Practices, electronic records and electronic signatures requirements, and regulations governing clinical trials and informed consent
• Experience with clinical system integrations, data flows, validation, and change control
• Project management and technical expertise, attention to detail, and excellent documentation and communication skills
• Meeting management and facilitation skills
• Excellent time management and organization skills in a fast-paced environment
• Sound problem resolution, judgment, and decision-making abilities
• Ability to work well in a team-based environment with minimal supervision

What you can expect from us

• In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising 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.

About Amgen

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