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Thermo Fisher Scientific Hiring for CDM Programmer II in Bengaluru: Clinical Data Management
Position Overview & Specifications
| Parameter | Official Specifications |
|---|---|
| Hiring Organization | Thermo Fisher Scientific (PPD Clinical Development) |
| Designation / Track | CDM Programmer II (Clinical Data Management) |
| Target Qualifications | B.Pharm, M.Pharm, M.Sc Life Sciences, B.Tech Bioinformatics |
| Experience Profile | 2 to 5 Years Clinical Database Programming |
| Technical Platforms | Medidata Rave EDC, Oracle InForm, Veeva CDMS, PL/SQL |
| Work Location | Bengaluru, Karnataka |
| Application Mode | Direct Official Thermo Fisher Workday Portal |
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 |
#1CDM Programmer II
Clinical Data Science / CDM |
Location: Bengaluru
|
Experience: 2 – 5 Yrs Online Portal
|
Key Roles & Detailed Responsibilities
- Execute end-to-end clinical data operations, trial documentation, or statistical programming workflows strictly aligned with Thermo Fisher Scientific’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.Pharm, M.Pharm, M.Sc Life Sciences, B.Tech Bioinformatics from an accredited university or approved technical institution.
- Experience Profile: 2 – 5 Years Experience 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:
Electronic Data Capture Systems (Medidata Rave / Oracle InForm)eCRF Design, Specification & User Acceptance Testing (UAT)Data Validation Plan (DVP) & Edit Check Logic ProgrammingDiscrepancy & Query Management Workflow LifecycleExternal Data Integration (Central Lab, ECG, PK Data Feeds)Medical Coding (MedDRA Hierarchy & WHODrug Global Dictionaries)Serious Adverse Event (SAE) Cross-Database ReconciliationInterim & Final Database Lock (DBL) Protocols & Blind ReviewsGood Clinical Data Management Practice (GCDMP Guidelines)21 CFR Part 11 Audit Trail & Electronic Signature Governance
Daily Operational Workflow & Core Shift Duties
Detailed technical breakdown of standard shift activities, laboratory/plant floor execution, and daily operational deliverables for CDM Programmer II (Clinical Data Management & EDC Programming):
Duty 1eCRF Specification & Form Design
Drafting electronic Case Report Form (eCRF) layouts, data dictionary specifications, and visit structures in Medidata Rave / InForm.
Duty 2Edit Check Programming & UAT
Writing logical edit checks for range validations, cross-form consistency, and performing User Acceptance Testing (UAT) prior to go-live.
Duty 3Query Management & Discrepancy Resolution
Running automated discrepancy scripts, reviewing manual clinical data listings, and issuing electronic queries to trial sites.
Duty 4External Data Reconciliation
Loading central laboratory, PK, and ECG data files and performing cross-platform discrepancy matching against eCRF clinical records.
Duty 5Database Lock (DBL) Preparation
Tracking 100% query closure, reconciling SAE databases, securing investigator e-signatures, and executing formal database lock.
Regulatory & Quality Compliance Framework
Candidates must demonstrate operational awareness and rigorous adherence to the following regulatory chapters and international standards governing this role:
SCDM GCDMP Guidelines
Data Management Best Practices
Comprehensive industry standard guidelines governing data management plans, CRF design, data validation, and query handling.
ICH GCP E6 (R2) Section 5.5
Trial Data Electronic Governance
Mandates validated computerized systems, robust audit trails, security access, and data backup procedures.
USFDA 21 CFR Part 11
EDC Electronic Records & Signatures
Enforces non-repudiation of investigator electronic signatures, password management, and unalterable electronic audit trails.
CDISC CDASH Standards
Standardized Data Collection
Basic standard for case report form variable naming and design to enable clean downstream SDTM transformation.
Tailored Resume Guidelines for CDM Programmer II (Clinical Data Management & EDC Programming)
- Highlight Core Technical Instrumentation & Software: Explicitly mention hands-on software platforms (Empower 3, SAS, Argus, EDC Rave) or laboratory equipment relevant to CDM Programmer II (Clinical Data Management & EDC Programming) 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 complete end-to-end workflow of the Clinical Data Management lifecycle from study setup to database lock?
Authoritative Answer: The CDM lifecycle comprises three distinct phases: Study Setup (protocol review, eCRF design, Data Management Plan [DMP] creation, Data Validation Plan [DVP] authoring, edit check programming, UAT, and EDC go-live); Study Conduct (data entry tracking, automated and manual query generation/resolution, third-party data loading, medical coding in MedDRA and WHODrug, SAE reconciliation with Pharmacovigilance, and protocol deviation reviews); and Study Closeout (resolution of all open queries, final data cleaning, investigator electronic signatures [e-signatures], quality audit, Blind Review Meeting, formal Database Lock [DBL], data extraction, and archiving of CDISC compliant datasets).
Authoritative Answer: The CDM lifecycle comprises three distinct phases: Study Setup (protocol review, eCRF design, Data Management Plan [DMP] creation, Data Validation Plan [DVP] authoring, edit check programming, UAT, and EDC go-live); Study Conduct (data entry tracking, automated and manual query generation/resolution, third-party data loading, medical coding in MedDRA and WHODrug, SAE reconciliation with Pharmacovigilance, and protocol deviation reviews); and Study Closeout (resolution of all open queries, final data cleaning, investigator electronic signatures [e-signatures], quality audit, Blind Review Meeting, formal Database Lock [DBL], data extraction, and archiving of CDISC compliant datasets).
Q: How do you perform Serious Adverse Event (SAE) Reconciliation between the Clinical Database (EDC) and the Safety Database (Argus/ArisG)?
Authoritative Answer: SAE Reconciliation ensures consistency between safety and clinical databases. Reconciled parameters include: Subject ID, Date of Birth/Age, Gender, Adverse Event verbatim term, Onset Date, Resolution Date, Outcome, Causality/Relatedness to study drug, Seriousness criteria, and Investigational Product lot/dose. Clinical data managers run automated reconciliation discrepancy reports on a monthly basis. Discrepancies are flagged via data queries to the clinical trial site or safety team for resolution prior to database freeze.
Authoritative Answer: SAE Reconciliation ensures consistency between safety and clinical databases. Reconciled parameters include: Subject ID, Date of Birth/Age, Gender, Adverse Event verbatim term, Onset Date, Resolution Date, Outcome, Causality/Relatedness to study drug, Seriousness criteria, and Investigational Product lot/dose. Clinical data managers run automated reconciliation discrepancy reports on a monthly basis. Discrepancies are flagged via data queries to the clinical trial site or safety team for resolution prior to database freeze.
Q: What mandatory criteria must be satisfied before executing a formal Database Lock (DBL)?
Authoritative Answer: Before locking the clinical database: all subject visits must be completed and marked ‘Clean’ in EDC; 100% of eCRF pages must be entered and verified by CRA monitoring; all data queries must be resolved and closed with zero pending discrepancies; medical coding for all terms must be approved by the study physician; SAE reconciliation must be 100% complete and signed off by Safety and CDM Leads; external lab/PK data must be fully reconciled; and all investigators must sign off on their site eCRFs. The formal DBL approval certificate is then signed by the Study Sponsor, Lead Biostatistician, and CDM Project Director.
Authoritative Answer: Before locking the clinical database: all subject visits must be completed and marked ‘Clean’ in EDC; 100% of eCRF pages must be entered and verified by CRA monitoring; all data queries must be resolved and closed with zero pending discrepancies; medical coding for all terms must be approved by the study physician; SAE reconciliation must be 100% complete and signed off by Safety and CDM Leads; external lab/PK data must be fully reconciled; and all investigators must sign off on their site eCRFs. The formal DBL approval certificate is then signed by the Study Sponsor, Lead Biostatistician, and CDM Project Director.
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 CDM Programmer II (Clinical Data Management & EDC Programming) at Thermo Fisher Scientific?
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Thermo Fisher Scientific’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 Thermo Fisher Scientific’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.Pharm, M.Pharm, M.Sc Life Sciences, B.Tech Bioinformatics. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Answer: Eligible qualifications include B.Pharm, M.Pharm, M.Sc Life Sciences, B.Tech Bioinformatics. 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 CDM Programmer II (Clinical Data Management & EDC Programming) at Thermo Fisher Scientific:
Thermo Fisher Scientific Recruitment 2026Thermo Fisher Scientific Careers IndiaThermo Fisher Scientific CDM Programmer II (Clinical Data Management & EDC Programming) VacancyCDM Programmer II (Clinical Data Management & EDC Programming) Jobs in Bengaluru, KarnatakaClinical SAS Programmer JobsCDISC SDTM ADAM DatasetsSAS Macro Programming CareersClinical Trial Data ReportingBase and Advanced SAS CertificationStatistical Programmer Salary IndiaB Pharmacy Jobs 2026M Pharmacy Pharmacology CareersMSc Chemistry Jobs Pharma IndustryBSc Life Sciences CareersPharma Jobs in Bengaluru, KarnatakaPharma Speed Post Verified Careers
Application Procedure
- Carefully review the functional eligibility criteria, academic qualifications, and key duties specified for CDM Programmer II (Clinical Data Management & EDC Programming) at Thermo Fisher Scientific 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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