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Fortrea Hiring for Solutions Developer Apprentice in Bangalore: Clinical IT Freshers
Position Overview & Specifications
| Parameter | Official Specifications |
|---|---|
| Hiring Organization | Fortrea Clinical Services India Private Limited |
| Designation / Track | Solutions Developer Apprentice – Clinical IT Systems |
| Target Qualifications | B.Tech / B.E, B.Pharm, MCA, M.Sc Computer Science / IT |
| Eligible Batches | 2024, 2025 and 2026 Graduating Batches |
| Experience Profile | Fresher / Apprentice (0 to 1 Year Experience) |
| Core Focus | Clinical Trial Software, API Integrations, SQL Database Queries & Agile Frameworks |
| Work Location | Bangalore, Karnataka, India |
| Application Mode | Direct Official Fortrea Workday Global Career Requisition |
Verified Vacancy Matrix & Hiring Tracks
Review all active hiring tracks below. Direct official application links for each position are provided at the bottom of this notification:
| # | Designation & Hiring Track | Work Location | Experience & Mode |
|---|---|---|---|
| 1 |
#1Solutions Developer Apprentice
Clinical Technology & Global Development Systems |
Location: Bengaluru
|
Experience: Fresher (0 – 1 Yr) Online Portal
|
Key Roles & Detailed Responsibilities
- Execute end-to-end clinical data operations, trial documentation, or statistical programming workflows strictly aligned with Fortrea’s Standard Operating Procedures (SOPs).
- Ensure 100% adherence to global regulatory frameworks including ICH-GCP guidelines, USFDA 21 CFR Part 11, and CDISC SDTM/ADaM submission standards.
- Perform technical quality reviews, trial master file (TMF) audits, safety event reconciliation, and clinical database validation deliverables.
- Collaborate cross-functionally with biostatisticians, clinical data managers, medical writers, and enterprise safety review boards.
Eligibility Criteria & Candidate Profile
- Academic Qualifications: Candidates must possess B.Tech / B.E Computer Science / IT / Biomedical, B.Pharm, MCA, M.Sc Computer Science from an accredited university or approved technical institution.
- Experience Profile: Fresher / Apprentice (0 – 1 Yr) with demonstrated hands-on technical proficiency in target operational workflows.
- Regulatory & Quality Knowledge: Solid foundational awareness of pharmaceutical compliance (cGMP, ICH-GCP, GLP, 21 CFR Part 11, or CDSCO standards).
- Core Competencies: Excellent analytical problem-solving skills, rigorous documentation hygiene, and strong verbal/written technical communication.
Core Technical Competencies & Instruments Matrix
Candidates possessing hands-on proficiency across the following analytical tools, software systems, and regulatory standards will receive priority evaluation:
Good Clinical Practice (ICH GCP E6 R2 Guidelines)Clinical Study Protocol Adherence & Subject EligibilitySource Data Verification (SDV) & Risk-Based Monitoring (RBM)Trial Master File (eTMF / Veeva Vault eTMF Architecture)Clinical Trial Management Systems (CTMS Platforms)Serious Adverse Event (SAE) Expedited Reporting WorkflowsInstitutional Ethics Committee (IEC / IRB) Submissions & ApprovalsInvestigational Product (IP) Accountability & Temperature LogsSite Initiation (SIV), Interim Monitoring (IMV) & Close-Out Visits (COV)CDSCO & USFDA Clinical Trial Regulatory Standards
Daily Operational Workflow & Core Shift Duties
Detailed technical breakdown of standard shift activities, laboratory/plant floor execution, and daily operational deliverables for Solutions Developer Apprentice – Clinical IT & Data Applications:
Duty 1Protocol Adherence & Feasibility Review
Evaluating trial protocols, inclusion/exclusion criteria, investigator site capacity, and patient recruitment projections.
Duty 2Site Monitoring Visits (SIV / IMV / COV)
Conducting site initiation visits, interim routine monitoring, and trial close-out visits in accordance with the monitoring plan.
Duty 3Source Data Verification (SDV)
Cross-verifying electronic Case Report Form (eCRF) entries against patient hospital charts, lab reports, and signed informed consent documents.
Duty 4Investigational Product (IP) Accountability
Auditing drug accountability logs, return records, temperature excursion logs, and secure storage compliance at clinical sites.
Duty 5Safety Event & SAE Surveillance
Verifying that any Serious Adverse Event (SAE) has been reported to the trial Sponsor and Ethics Committee strictly within 24 hours.
Regulatory & Quality Compliance Framework
Candidates must demonstrate operational awareness and rigorous adherence to the following regulatory chapters and international standards governing this role:
ICH GCP E6 (R2)
Good Clinical Practice
Unified international ethical and scientific quality standard for designing, conducting, and reporting trials involving humans.
NDCTR 2019 (CDSCO Rules)
Indian Clinical Trial Governance
Comprehensive Indian statutory framework regulating ethics committees, informed consent audio-video recording, and compensation.
USFDA 21 CFR Part 312 & 50/56
IND & Human Subjects Protection
Federal regulations establishing sponsor responsibilities, protocol amendments, safety reporting, and IRB approvals.
Declaration of Helsinki
Ethical Principles for Medical Research
World Medical Association ethical principles guiding physicians and investigators in biomedical human research.
Tailored Resume Guidelines for Solutions Developer Apprentice – Clinical IT & Data Applications
- Highlight Core Technical Instrumentation & Software: Explicitly mention hands-on software platforms (Empower 3, SAS, Argus, EDC Rave) or laboratory equipment relevant to Solutions Developer Apprentice – Clinical IT & Data Applications at the top of your resume.
- Quantify Accomplishments & Throughput: Instead of passive duty descriptions, quantify measurable deliverables (e.g., ‘Validated 15+ analytical methods per ICH Q2’, ‘Processed 120+ clinical safety ICSRs per month’, ‘Supervised 50+ commercial batches with zero deviations’).
- Standardize on ATS-Friendly Clean Formatting: Use standard single-column reverse-chronological format with clean bullet points. Strictly avoid multi-column layouts, graphics, icons, or text boxes that confuse automated enterprise ATS parsers.
- Calibrate Regulatory Terminology: Integrate exact industry compliance acronyms (e.g., cGMP, ICH-GCP, ALCOA+, 21 CFR Part 11, USFDA audit readiness) naturally throughout your project and experience narratives.
Technical Interview Assessment & Guidance
Q: What is the statutory timeline and procedure for reporting a Serious Adverse Event (SAE) occurring during a clinical trial?
Authoritative Answer: According to ICH GCP guidelines and CDSCO/USFDA regulations, the Principal Investigator must report any SAE to the trial Sponsor and Ethics Committee within 24 hours of occurrence or awareness. The Initial SAE Report must detail patient demographics, event description, causality assessment, and outcome. Fatal or life-threatening unexpected adverse drug reactions (SUSARs) must be reported to the regulatory authority by the sponsor within 7 calendar days, followed by a complete report within an additional 8 days. All other serious unexpected events must be filed within 15 calendar days.
Authoritative Answer: According to ICH GCP guidelines and CDSCO/USFDA regulations, the Principal Investigator must report any SAE to the trial Sponsor and Ethics Committee within 24 hours of occurrence or awareness. The Initial SAE Report must detail patient demographics, event description, causality assessment, and outcome. Fatal or life-threatening unexpected adverse drug reactions (SUSARs) must be reported to the regulatory authority by the sponsor within 7 calendar days, followed by a complete report within an additional 8 days. All other serious unexpected events must be filed within 15 calendar days.
Q: How do you perform 100% Source Data Verification (SDV) to detect protocol deviations?
Authoritative Answer: SDV requires cross-checking electronic Case Report Form (eCRF) entries against raw source documentation (hospital electronic medical records, clinical lab reports, imaging scans, and signed patient diaries). Key verification points include: verified written Informed Consent obtained prior to any study-related procedure; inclusion/exclusion criteria fulfillment; primary efficacy and safety endpoints; medication dosing logs; and concurrent medications. Any discrepancy is flagged via an electronic query in the EDC system and logged in the site monitoring report.
Authoritative Answer: SDV requires cross-checking electronic Case Report Form (eCRF) entries against raw source documentation (hospital electronic medical records, clinical lab reports, imaging scans, and signed patient diaries). Key verification points include: verified written Informed Consent obtained prior to any study-related procedure; inclusion/exclusion criteria fulfillment; primary efficacy and safety endpoints; medication dosing logs; and concurrent medications. Any discrepancy is flagged via an electronic query in the EDC system and logged in the site monitoring report.
Q: What essential documents must be maintained in the Investigator Site File (ISF) and Trial Master File (TMF)?
Authoritative Answer: Per ICH GCP Section 8, essential documents are categorized across trial phases: Before Trial Initiation (approved protocol, Investigator’s Brochure, signed investigator agreements, Ethics Committee approvals, financial disclosure, normal lab reference ranges); During Trial Conduct (curriculum vitae updates, monitoring visit logs, IP shipping and temperature logs, SAE notifications, protocol amendments); and After Trial Completion (IP destruction certificates, final subject identification code list, clinical study report summary, and audit certificates).
Authoritative Answer: Per ICH GCP Section 8, essential documents are categorized across trial phases: Before Trial Initiation (approved protocol, Investigator’s Brochure, signed investigator agreements, Ethics Committee approvals, financial disclosure, normal lab reference ranges); During Trial Conduct (curriculum vitae updates, monitoring visit logs, IP shipping and temperature logs, SAE notifications, protocol amendments); and After Trial Completion (IP destruction certificates, final subject identification code list, clinical study report summary, and audit certificates).
Mandatory Documents Checklist for Interview & Verification
Ensure you organize the following original credentials and self-attested photocopies for technical interviews and HR onboarding verification:
Curriculum Vitae (2 Hard Copies)
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Academic Certificates & Marksheets
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Government Photo Identification
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Past 3 Months Salary Slips & Bank Records
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Relieving & Appointment Letters
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Passport Photographs & Professional Registration
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
Frequently Asked Questions (FAQ)
Q: What is the official application procedure for Solutions Developer Apprentice – Clinical IT & Data Applications at Fortrea?
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Fortrea’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Fortrea’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Q: What academic backgrounds and degrees are eligible for this hiring drive?
Answer: Eligible qualifications include B.Tech / B.E Computer Science / IT / Biomedical, B.Pharm, MCA, M.Sc Computer Science. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Answer: Eligible qualifications include B.Tech / B.E Computer Science / IT / Biomedical, B.Pharm, MCA, M.Sc Computer Science. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Q: What is the typical interview and shortlisting workflow?
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Related Career Pathways & Functional Specializations
Associated functional specializations and recruitment tracks for Solutions Developer Apprentice – Clinical IT & Data Applications at Fortrea:
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Application Procedure
- Carefully review the functional eligibility criteria, academic qualifications, and key duties specified for Solutions Developer Apprentice – Clinical IT & Data Applications at Fortrea above.
- Calibrate your resume to highlight relevant instrumentation, software platforms, or cGMP/GCP regulatory compliance.
- Ensure your contact details, active mobile number, and email address are up to date in your CV.
- Click the official application button below to access the direct employer recruitment portal or HR email channel with zero intermediary charges.
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