Premier Research is inviting applications for the position of Standards Support Specialist (Fixed-Term Contract). This remote opportunity is ideal for professionals with experience in Clinical Data Management (CDM), Electronic Data Capture (EDC) systems, CRF design, metadata management, and CDISC standards. Candidates with 2–3 years of experience in clinical research and data management can apply for this exciting global CRO role.
The position offers the flexibility of remote work while contributing to critical clinical trial data standardization activities that support innovative biotech, medtech, and pharmaceutical companies worldwide.
About Premier Research
Premier Research is a global clinical research, product development, and consulting company helping biotech, specialty pharma, and medical device organizations bring life-changing therapies and technologies to patients. The company specializes in supporting clinical development programs through innovative research solutions and operational excellence.
Job Details
| Particulars | Details |
|---|---|
| Job Title | Standards Support Specialist |
| Employment Type | Full-Time |
| Contract Type | Fixed-Term (Until December 2026) |
| Location | Remote – India |
| Experience Required | 2–3 Years |
| Industry | Clinical Research / Clinical Data Management |
| Working Hours | 11:30 AM – 7:30 PM IST (Monday to Friday) |
Key Responsibilities
The selected candidate will be responsible for supporting clinical data standards and metadata management activities, including:
- Populating the Metadata Repository based on approved impact assessments and CRF specifications.
- Creating Case Report Form (CRF) specifications and annotations.
- Managing metadata within Clinical Data Management Systems (CDMS).
- Developing new graphical CRF modules based on approved standards.
- Uploading Data File Specifications and Statistical Guidance Documents.
- Managing standards workflow and change control processes.
- Following sponsor and internal Standard Operating Procedures (SOPs).
- Collaborating with sponsor teams to resolve standards-related issues.
- Supporting additional clinical data standards activities as required.
Eligibility Criteria
Educational Qualification
Candidates should possess:
- Bachelor’s Degree from an accredited institution, preferably in a technical, life sciences, pharmacy, biotechnology, or related discipline.
- Equivalent combination of education, training, and relevant experience may also be considered.
Experience Required
Applicants should have:
- 2–3 years of experience using Clinical Data Management Systems (CDMS) and EDC platforms.
- Hands-on experience with systems such as:
- Oracle RDC
- Oracle Inform
- Medidata Rave
- DataLabs
- Similar EDC platforms
Preferred Skills
- Knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards.
- Strong analytical and organizational skills.
- Excellent verbal and written English communication.
- Ability to manage multiple projects simultaneously.
- Strong customer-focused mindset and stakeholder management abilities.
- Experience in metadata repository management and CRF design.
Why Join Premier Research?
Working at Premier Research offers several advantages:
- Fully Remote Work Opportunity
- Global Clinical Research Exposure
- Collaborative International Team Environment
- Career Development and Learning Opportunities
- Work-Life Balance Focus
- Exposure to Clinical Data Standards and Metadata Governance
Who Should Apply?
This opportunity is particularly suitable for:
- Clinical Data Management Professionals
- Clinical Data Coordinators
- EDC Specialists
- CDM Associates
- Metadata Management Specialists
- Clinical Research Professionals with CRF Design Experience
- CDISC Standards Professionals
How to Apply
