Clinical Operations Specialist

Role: Clinical Operations Specialist

Location: Mumbai

To know more about our company, you can visit the company website SIRO Clintech

Key Responsibilities:

1. Execute clinical studies/projects/activities and meet planned deliverables in line with agreed and defined roles and responsibilities.

2. Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable, independent or under the responsibility of (Sr.) Clinical Project Manager (CPM) as applicable: Update data, timelines, milestones, Ethics Committee (EC) / Health Authority (HA) authorizations, etc. on an ongoing basis.

3. Support (Sr.) CPM with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. Perform Good receipt booking in line with Vendor financial report and study status, as required.

4. Support set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF, independent or under responsibility of (Sr.) CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.

5. Track clinical studies/projects/activities progress, ensure CTMS, TMF and other systems as applicable are up to date. Address questions; escalate issues or critical findings to project lead (Sr./CPM).

6. Support in External Service Provider coordination:

1. Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for clinical study/projects/activities at start, conduct and close-out. Follow-up with External Service Providers on day-to-day operations
2. Ensure all data is reported to the Clinical Trial Team (CTT) and available to business colleagues
3. Logistical support to study team (internal and external) onboarding process

7. Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation.

8. Support CTT in study start-up activities, recruitment and close-out activities as required.

9. Champion the implementation of operational changes and transitions as required.

COS may additionally support below activities as deemed necessary by reporting manager or Head CPM:

• Responsible for developing monitoring plans and study specific tools as applicable
• Provide input to eCRF design & review, and other documents and systems, as applicable
• Responsible for central monitoring and data oversight on assigned clinical study(s) using available online data sources (eCRF, IRT, central lab, etc.) to ensure consistency, plausibility, completeness and correctness of the data
• Communicate any observations, deviations to protocol, safety alerts, quality issues, trend/patterns, risk factors etc. (that may affect the planned conduct of the study(s)) to the clinical team and CRAs for timely follow-up of actions and issue resolution
• Collaborate with Medical Lead to identify any safety trends, is a key team member of the Clinical Trial Team (CTT) and will lead the discussion in Data Review Team (DRT) meetings
• Prepare and share the Central Monitoring Package where applicable and agreed with the CRAs prior to monitoring visits

Preferred candidate profile

Experience of minimum 4 years into managing project activities is mandatory. Preferred candidate should have end to end experience of Clinical Trial Studies and should have preferably worked as CRA/CTA.

Candidate should be willing to work from Client/Siro office 5 days in a week.

Mumbai based candidates/candidates willing to relocate to Mumbai can apply for this role.