Data Acquisition Lead- eConsent

Amgen Technology; Hyderabad; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Amgen is seeking a Data Acquisition Lead - eConsent to drive the collection, integration, and quality of non-CRF data and associated clinical systems. You will ensure timely, accurate data delivery with regulatory compliance across the portfolio, collaborating with internal teams and external suppliers to maintain data traceability.

Ideal candidates bring 8–12 years in life sciences, with 3+ years in clinical research, and strong experience managing supplier relationships, data flows, and system

Qualifications

• Doctorate, Masters, or Bachelor's degree with 8–12 years of experience.
• 5 years of work in life sciences or related field, including 3 years in clinical research.
• Experience with external suppliers (CROs, labs, eCOA, etc.).
• Knowledge of Good Clinical Practices and electronic signatures.
• Experience with clinical system integrations and data flows.

Responsibilities

• Lead acquisition, integration, and quality management of non-CRF data and systems.
• Ensure data timeliness, accuracy, and regulatory compliance across studies.
• Define supplier data transfer specifications and oversee data flows.
• Resolve data quality issues and reconciliation with study teams and suppliers.
• Coordinate with Clinical Systems, vendors, and global/local study teams.
• Oversee testing, deployment, and change control for systems.
• Monitor study data documentation and traceability throughout the lifecycle.

Skills

Clinical data management

Regulatory compliance

Documentation

Communication skills

Project management

Education

Bachelor’s/Master’s/Doctorate in life sciences

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 mission to serve patients living with serious illnesses drives all that we do.

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 Overview

Data Acquisition Lead - eConsent

What you do

Lets do this. Lets change the world. In this vital role you will lead the acquisition, integration, and quality management of non-CRF (external/supplier) clinical trial data and associated clinical systems, ensuring they are timely, accurate, and fit-for-purpose to support study delivery and analytics, with regulatory compliance. This role sits within the Data Management organization, and responsibilities will be assigned to you based on your experience and subject matter expertise to deliver systems and data quality across the clinical portfolio.

• 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 elevate 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

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

Doctorate degree OR Masters degree OR Bachelors 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