Roche is inviting applications for the Study Start-up Specialist (SSUS) position in Mumbai, India. The role is part of Roche Pharma Global Clinical Operations (PDG) and focuses on clinical trial start-up, regulatory submissions, clinical site activation, essential document management, and clinical trial contract coordination.
Candidates with a university degree in life sciences or an equivalent field, along with knowledge of clinical trial regulations and study start-up processes, can apply.
Roche Study Start-up Specialist Job Details
| Job Detail | Information |
|---|---|
| Company | Roche |
| Job Title | Study Start-up Specialist (SSUS) |
| Location | Mumbai, India |
| Job Type | Full-time |
| Department | Pharma Global Clinical Operations |
| Job Requisition ID | 202610-126575 |
| Qualification | University degree in life sciences or an equivalent field |
| Preferred Education | Postgraduate or master’s degree |
| Application Mode | Online |
Position: Study Start-up Specialist
The Study Start-up Specialist will facilitate clinical trial start-up activities, coordinate regulatory and ethics committee submissions, support site activation, manage essential study documentation, and help ensure compliance with applicable regulations and standard operating procedures (SOPs).
Roles and Responsibilities
The selected candidate will be responsible for the following activities:
- Clinical Trial Start-up: Support and execute study start-up strategies to accelerate clinical site activation in collaboration with internal teams, external partners, contract research organisations (CROs), and clinical sites.
- Regulatory Submissions: Prepare and manage submission packages for Health Authorities (HA) and Ethics Committees (EC/IRB).
- Informed Consent Documentation: Adapt Informed Consent Forms (ICFs), respond to Requests for Information (RFIs), and manage study amendments.
- Essential Document Management: Collect, verify, and submit site documents, including CVs, patient materials, and biobank details, to the Trial Master File (TMF).
- Clinical Trial Contracts: Support contract negotiations and execution, including confidentiality, indemnity, and amendments.
- Financial Coordination: Oversee site payments and coordinate accrual and purchase order reconciliations through shared service centres.
- Issue Management: Identify potential study start-up bottlenecks, manage escalations, and support local vendors.
- Tracking and Reporting: Maintain accurate tracking systems and contract data while ensuring compliance with local regulatory requirements and SOPs.
Eligibility and Qualifications
Candidates applying for the Roche Study Start-up Specialist vacancy should meet the following educational and professional requirements:
- A university degree in life sciences or an equivalent field.
- Accepted degree examples include MD, PhD, MA/MS, and BA/BS.
- A postgraduate or master’s degree is highly desirable.
- Strong understanding of clinical trial regulations.
- Knowledge of Health Authority and Ethics Committee guidelines.
- Understanding of SOPs relevant to clinical trial start-up and execution.
Required Skills
Roche is looking for candidates with the following skills and capabilities:
- Clinical trial regulatory compliance and documentation management.
- Regulatory submission preparation and coordination.
- Clinical site activation and study start-up support.
- Collaboration with global study teams, CROs, clinical site staff, and local vendors.
- Attention to detail when managing complex documentation.
- Experience in budgeting, site payments, or contract negotiations.
- Strong organisational and prioritisation skills.
- Ability to manage multiple priorities, tracking systems, and compliance requirements.
- Fluency in written and spoken English and the local language or languages of the host country.
