@sakshilad
Clinical Research Associate at MACLEODS PHARMACEUTICALS LTD. maintaining audit readiness across 12+ clinical trial sites.
IndiaAt MACLEODS PHARMACEUTICALS LTD., I manage clinical trial sites through source data verification and review, informed consent review, and protocol compliance assessment. I maintained audit readiness with zero critical findings across sponsor inspections.
I’ve supported 5 CTRI submissions and currently support a Phase IV Generalized Anxiety Disorder study and 3 Diabetes studies. My trial experience also includes Respiratory, Infectious Disease, and Dermatology studies.
Work history, roles, and key accomplishments
Macleods Pharmaceuticals Ltd.
Jun 2023 - Present (3 years 4 months)
Managed 12+ active clinical trial sites, conducting SDV/SDR, source documentation review, ICF review, and protocol compliance assessment, ensuring 100% compliance with SOPs and ICH-GCP standards. Identified and mitigated site-level risks through investigator and site-staff training, improving recruitment efficiency and reducing screen-fail rates.
Degrees, certifications, and relevant coursework
Master of Science, Clinical Research
2021 - 2023
Grade: 8.33
Pursued MSc in Clinical Research, achieving a GPA of 8.33.
Bachelor of Science, Microbiology
2018 - 2021
Grade: 9.3
Completed BSc in Microbiology with a GPA of 9.3.
ICH GCP E6 R3 Certification, Clinical Research
Certification in ICH GCP E6 R3.
Collecting High-Quality ADR Reports Certification, Pharmacovigilance
Certification in Collecting High-Quality ADR Reports.
Good Clinical Practice Certification, Clinical Research
Certification in Good Clinical Practice.
Software and tools used professionally
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