Amgen is inviting applications for the position of Study Delivery Associate in Hyderabad, India. The position falls under the Clinical Development career category and involves providing administrative and operational support for clinical trial management activities.
The role focuses on clinical study coordination, clinical trial documentation, Trial Master File (TMF) management, Clinical Trial Management System (CTMS) maintenance, study start-up activities, and regulatory compliance.
Candidates with a bachelor’s degree or equivalent clinical execution experience can apply. Experience in life sciences, biopharmaceutical clinical research, and global clinical trials is preferred.
Job Details
| Particulars | Details |
|---|---|
| Company | Amgen |
| Job Title | Study Delivery Associate |
| Career Category | Clinical Development |
| Job Location | Hyderabad, India |
| Work Mode | On-site |
| Employment Type | Full-time |
| Qualification | Bachelor’s degree or equivalent experience |
| Experience | 2 years in life sciences or medically related fields preferred |
| Job Requisition ID | R-260260 |
Position
Study Delivery Associate
The Study Delivery Associate supports clinical trial management activities by coordinating study operations, maintaining clinical systems and documentation, tracking study timelines, and supporting regulatory compliance and inspection readiness.
Job Responsibilities
1. Study Coordination
- Support the setup and maintenance of study-level trackers, dashboards, and timelines.
- Communicate study progress, timelines, and deliverables to the Study Delivery Manager.
- Track and follow up on study actions, including risk mitigation activities.
- Assist with the preparation and documentation of risk and quality reviews.
- Ensure completion of study team training and inspection readiness activities.
- Assist with trial-related events, global site communications, and investigator meeting logistics.
- Support study start-up activities, including system setup, supplier access management, ICF tracking, and document readiness.
- Support vendor relationships and site engagement strategies.
- Manage the shipment, reconciliation, and analysis of biological samples.
- Coordinate investigational product logistics and reconciliation processes.
2. Data and Systems Management
- Maintain clinical trial systems, including CTMS and study training systems.
- Ensure timely and accurate data entry.
- Support system access requests and access management.
3. Document Preparation
- Assist with preparing, reviewing, and maintaining clinical study documentation.
- Support regulatory submissions, monitoring plans, and study guides.
- Assist with Trial Master File (TMF) filing.
4. Process Improvement and Knowledge Sharing
- Contribute to process improvement activities.
- Share knowledge and experience to support consistency across clinical studies.
Eligibility Criteria and Qualifications
Candidates must meet one of the following basic educational and experience requirements:
- Bachelor’s degree; OR
- Associate’s degree with 4 years of clinical execution experience; OR
- High school diploma / GED with 6 years of clinical execution experience.
Preferred Experience
- 2 years of work experience in a life sciences or medically related field.
- At least 1 year of biopharmaceutical clinical research experience obtained through clinical trial work in a biotechnology, pharmaceutical, or CRO company.
- Experience working on global clinical trials.
Required Skills and Competencies
Candidates should have the following knowledge and skills:
- Understanding of clinical trial processes, operations, and oversight in biotechnology, pharmaceutical, or CRO environments.
- Strong proficiency in Microsoft Word, Excel, PowerPoint, and relevant documentation and data management software.
- Experience tracking and filing essential clinical trial documents, including protocols, informed consent forms (ICFs), and regulatory submissions.
- Knowledge of document version control and inspection-ready documentation practices.
- Working knowledge of:
- Clinical Trial Management Systems (CTMS)
- Electronic Trial Master File (eTMF)
- Electronic Data Capture (EDC)
- Microsoft Office applications
- Ability to maintain accurate and timely clinical trial data.
- Understanding of clinical trial data flow, investigator documentation, and protocol adherence.
- Knowledge of regulatory compliance requirements.
- Cultural sensitivity and ability to collaborate with global teams.
- Ability to identify, highlight, and resolve issues.
- Curiosity and willingness to take on new responsibilities.
