Damini Gorakh Shahane

Professional Summary:

Detail-oriented Clinical Documentation Specialist with expertise in clinical trial documentation, regulatory compliance, and clinical data validation. Well-versed in ICH-GCP, FDA CFR 21, and essential trial documents such as ICFs, IBs, CRFs, Protocols, and eTMF. Strong analytical skills in clinical trial data interpretation, quality control, and document lifecycle management. Seeking to leverage my clinical research knowledge and regulatory expertise to ensure accuracy and compliance in clinical documentation. Completed Clinical Data Management internship program on Castor EDC-CDMS.

Key Skills & Expertise:

• Clinical Documentation Expertise: ICFs, IBs, CRFs, Study Protocols, TMF, SOPs
• Regulatory & Compliance Knowledge: ICH-GCP, FDA CFR 21, IRB/IEC processes
• Clinical Data Validation & Review
• Document Quality Control & Compliance
• Clinical Trial Reporting & Interpretation
• Clinical Data Categorization & Organization
• Pharmacovigilance & Safety Reporting
• Medical Terminologies & Drug Development Process

Professional Experience:

Larvol – Associate Analyst (July 2023 – Present) | Pune, India

• Strong understanding of clinical trial documentation, including ICFs, IBs, CRFs, Protocols, TMF, and SOPs.
• …

Innoplexus – Junior Knowledge Associate (June 2020 – July 2023) | Pune, India

• Gained extensive knowledge of clinical trial documentation through data validation and analysis.
• …

Education & Certifications:

• Bachelor of Pharmacy (B. Pharm) – Poona College of Pharmacy, Pune (8.9 CGPA)
• Post Graduation Diploma in Clinical Research – Technobridge Institute (A+)
• …

Technical Skills:

• SAS
• Clinical Data Management Internship (Castor EDC-CDMS)
• MS Excel, MS Word, MS PowerPoint

Languages:

• English – Fluent
• Hindi – Fluent
• Marathi – Native
• Korean – Intermediate (Completed Level 4 from Indo-Korean Center)

Achievements & Additional Information:

• Received appreciation certificates for academic excellence & extracurricular activities
• Certified in Elementary & Intermediate Drawing Exams
• Participated in drama and sports competitions

Skills: Clinical Documentation, Regulatory Compliance, Clinical Data Validation, Quality Control, Clinical Trial Reporting, Pharmacovigilance, Medical Terminologies, SAS, MS Excel.

Cover Letter:

�� Pune, India
 
**Subject:** Application for Clinical Data Management Position
Dear [AIIMS],
I am writing to express my keen interest in the **Clinical Data Management** position at [AIIMS]. With a strong foundation in **clinical documentation, data validation, and regulatory compliance**, I am eager to contribute my expertise to ensure the accuracy and integrity of clinical trial data.
As an **Associate Analyst at Larvol**, I have developed a comprehensive understanding of **clinical trial documentation**, including **ICFs, IBs, CRFs, Study Protocols, and eTMF**. My role involves **monitoring and reviewing clinical study updates**, ensuring data accuracy, and supporting documentation compliance. Prior to this, as a **Junior Knowledge Associate at Innoplexus**, I worked extensively on **clinical data validation, regulatory compliance under ICH-GCP guidelines, and document classification**, strengthening my analytical skills in **data interpretation and trial documentation management**.
In addition to my professional experience, I have completed a **Clinical Data Management internship on Castor EDC-CDMS**, equipping me with hands-on expertise in **electronic data capture, case report form (CRF) design, and database validation**. My background in **Pharmacy (B. Pharm)** and certifications in **Clinical Research and SAS programming** further reinforce my ability to handle complex clinical datasets while maintaining compliance with **ICH-GCP, FDA CFR 21, and IRB/IEC guidelines**.
I am excited about the opportunity to apply my **clinical research knowledge, regulatory expertise, and data management skills** to your organization. I look forward to the possibility of discussing how my experience aligns with your team’s needs. Please feel free to contact me at your convenience.
Thank you for your time and consideration. I look forward to your response.
**Best regards,**
 **Damini Gorakh Shahane**