Samahitha Research Solutions is hiring experienced Clinical Research professionals in Bengaluru for two positions: Team Lead – Clinical Operations and Site Specialist.
These opportunities are suitable for professionals with experience in clinical operations, clinical research, clinical trial management, site management, CRC coordination, GCP compliance, regulatory activities, TMF management and clinical trial monitoring.
Samahitha Research Solutions operates as a full-service CRO providing clinical development and biopharmaceutical services, including clinical operations, clinical data management, pharmacovigilance, clinical supply management and site management.
Current Samahitha Job Openings
| Position | Experience | Location |
|---|---|---|
| Team Lead – Clinical Operations | 3+ Years | Bengaluru |
| Site Specialist | 1+ Year | Bengaluru |
1. Team Lead – Clinical Operations
Job Location: Bengaluru, Karnataka
Experience: 3+ years in Clinical Research
Industry: Clinical Research / CRO
Employment Type: Full-time
Role Overview
The Team Lead – Clinical Operations will oversee clinical trial activities, coordinate CRAs and CTAs, manage subcontractors and study documentation, support regulatory activities, oversee clinical supplies and TMF processes, and ensure trials are conducted according to protocol, GCP and applicable regulatory requirements.
Key Responsibilities
- Maintain confidentiality of proprietary information belonging to Samahitha, sponsors, investigator sites and third parties.
- Manage and oversee subcontractor activities associated with assigned clinical trials.
- Coordinate with clinical laboratories, translation agencies, printing agencies and other vendors.
- Develop or customize study documents in consultation with sponsors.
- Manage study-related translations.
- Coordinate regulatory activities and submission packages.
- Verify regulatory documents for accuracy and completeness.
- Communicate new approvals and updated study documents to CRAs and CTAs.
- Plan and participate in investigator meetings.
- Support adverse event reporting during clinical trials.
- Coordinate clinical trial supplies, including quantity, storage and shipment requirements.
- Maintain accountability records for clinical supplies.
- Develop and maintain the Trial Master File (TMF).
- Review monitoring reports, contact reports, correspondence and study documentation.
- Manage site initiation, routine monitoring and site closure activities.
- Coordinate CRAs and CTAs working on assigned clinical trials.
- Maintain databases required for study administration.
- Provide enrollment and study progress information to sponsors and management.
- Manage data clarification workflows.
- Prepare co-monitoring visit plans and conduct co-monitoring visits.
- Maintain investigator and study team information.
- Support study communication through newsletters, meetings and conference calls.
Ideal Candidate Profile
Candidates should have hands-on experience in clinical research and clinical operations, with strong knowledge of clinical trial documentation, site management, GCP, monitoring activities and study coordination.
Experience with TMF management, regulatory submissions, clinical supplies, CRAs, CTAs, subcontractor management and investigator site coordination would be highly relevant.
2. Site Specialist
Job Location: Bengaluru, Karnataka
Experience: 1+ year in Clinical Research
Industry: Clinical Research / Site Management
Employment Type: Full-time
Role Overview
The Site Specialist will coordinate clinical trial activities at assigned sites, supervise Clinical Research Coordinators (CRCs), monitor patient and documentation activities, track site performance and report progress or issues to the Senior Manager – Clinical Operations.
Key Responsibilities
- Coordinate clinical trial activities at assigned sites.
- Monitor day-to-day activities of CRCs.
- Ensure CRCs complete assigned activities accurately and on time.
- Coordinate with Principal Investigators, Co-Investigators, CRCs and site personnel.
- Monitor patient screening, recruitment, enrollment, visits, follow-ups and retention.
- Track patient visit schedules.
- Monitor essential documents, study logs and source-related records.
- Ensure site activities comply with protocol, SOPs, GCP and applicable regulations.
- Follow up on pending documents, signatures, approvals and forms.
- Maintain site, patient and CRC trackers.
- Monitor protocol deviations, missed visits and patient withdrawals.
- Identify gaps in CRC performance and study conduct.
- Provide operational guidance to CRCs.
- Conduct regular follow-ups with CRCs.
- Coordinate site meetings, training and study visits.
- Support CRC and site staff onboarding.
- Monitor site performance against timelines and recruitment targets.
- Follow up on outstanding action items.
- Maintain records of site communications and follow-ups.
- Prepare regular site activity and progress reports.
- Report recruitment, patient visits, documentation, deviations and site performance.
Ideal Candidate Profile
This role is suitable for clinical research professionals with experience in clinical trial site coordination, CRC management, patient recruitment, site documentation, GCP compliance and clinical study operations.
Candidates with practical exposure to investigator sites, clinical trial coordination, patient tracking and study documentation may be particularly well suited.
Why Consider These Clinical Research Jobs?
Working with Samahitha can provide exposure to different areas of clinical development and site operations. The company’s official website describes Samahitha as a full-service CRO with capabilities spanning clinical operations, clinical data management, pharmacovigilance, clinical supply management and site management.
For professionals building careers in clinical research, these roles can provide exposure to:
- Clinical trial operations
- Investigator site management
- Clinical monitoring
- CRC coordination
- GCP compliance
- Regulatory documentation
- Trial Master File management
- Clinical trial supplies
- Patient recruitment and retention
- Study documentation and reporting
Eligibility
Team Lead – Clinical Operations
- 3+ years of experience in Clinical Research
- Relevant experience in clinical operations and clinical trial management preferred
- Knowledge of GCP and clinical trial processes
- Experience coordinating CRAs/CTAs and investigator sites is advantageous
Site Specialist
- 1+ year of experience in Clinical Research
- Experience in clinical trial/site coordination preferred
- Knowledge of GCP, clinical documentation and site processes
- CRC/site management experience is advantageous
Note: The supplied vacancy announcement specifies experience requirements but does not specify a particular educational degree. Candidates should verify the employer’s current requirements before applying.
Job Location
Bengaluru, Karnataka, India
Samahitha’s official website lists its Bengaluru head office in Jayanagar, Bengaluru, Karnataka.
Salary
The vacancy announcement does not disclose compensation.
For SEO/schema purposes, do not present an estimated salary as an employer-confirmed salary. If Pharmabharat wants to include a salary estimate, it should be clearly labelled as an estimated market range, not the company’s advertised compensation.
Suggested editorial estimates:
- Team Lead – Clinical Operations: ₹6–10 LPA
- Site Specialist: ₹3–6 LPA
I recommend keeping these out of the visible job facts unless Pharmabharat has an independent salary source.
How to Apply
Interested and eligible candidates should send their updated resume to:
Applicants should mention the position title clearly in the email subject line and ensure their resume highlights relevant clinical research experience.
Application Email: career@samahitha.com