Sadaf Shekh

About Sadaf Shekh

Highly motivated, results-oriented Clinical Research Professional with more than 15 years of rich experience in the field of Clinical Research,Proficient in Compliance of Protocol with GCP Guidelines, Clinical Trial Process, Activity Flow Chart, Subject Screening, Randomization, Drug Accountability, AE/SAE Reporting, Auditing etc.Ability to lead a team of multidisciplinary professional and team building activities,Expertise in DCF, Query Handling and report preparationAbility to enhance the quality of work using Innovative Work Techniques, with strong Organizational and Interpersonal SkillsExpertise in Clinical Monitoring, Quality Control, Adverse Events Reporting Procedures and Good Clinical PracticeGood working knowledge in ICH/GCP guidelines and other regulatory guidelines relevant to clinical research in IndiaEntrusted by physicians and frequently requested to assist them in higher-risk procedures involving split- second decision makingOutgoing and motivated with high standards of performance and attention to detail in any assignmentRecognized for unique blend of intelligence, self-confidence, and sociable personality, enabling immediate rapport with people at all levelsReceived special appreciation for best problem solving skills and Team workEnsured that highest service standards are maintained for servicing to Management by maintaining minimum turn-around-timeBest Contribute Award in the clinical study for recruiting targeted patient with safety, efficacy & timeline.

Experience

1. Senior Manager

   Fortrea

   Jun 2025 — Present

Education

• T. John College, Bangalore affiliated to Bangalore University

  Master's degree, Biotechnology

  2006 — 2008

• Holkar Science College

  Bachelor's degree, Biotechnology

  2003 — 2006

• Pune University

  PG Certificate, clinical research and clinical data management

  2007 — 2008

• A3 Institute of professional studies, dar es salam, Tanzania

  Diploma , Hospital Administration

  2015 — 2016

Skills

• Regulatory Submissions
• Hospital Administration
• CRO
• Gcp
• Biotechnology
• Medical Writing
• Regulatory Affairs
• Endocrinology
• Dermatology
• Pharmaceutical Industry
• Sop
• Fda
• Drug Safety
• Clinical Operations
• Ich-Gcp
• Patient Recruitment
• Edc
• Therapeutic Areas
• Pharmacology
• Ctms
• Infectious Diseases
• Pharmaceutics
• Phase I
• Electronic Data Capture (Edc)
• Good Clinical Practice (Gcp)
• Clinical Research Associates
• Clinical Data Management
• Clinical Trials
• Oracle Clinical
• Clinical Research
• Clinical Pharmacology
• Oncology
• Protocol
• Neurology
• Informed Consent
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Clinical Development
• Cardiology
• Pharmacovigilance