Rohit Bodkhe – Unlocking the Secrets of Clinical Data Management: A Journey from Student to Professional

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Rohit Bodkhe – Curriculum Vitae


Rohit Bodkhe – Curriculum Vitae

Contact Address

Permanent Address:

Plot no 24, Osmanpura, Aurangabad, Maharashtra-431001.

Career Objective

Self-motivated, highly passionate and hardworking Fresher looking for an opportunity to work in a challenging organization to utilize skills and knowledge. Detail-oriented and motivated M.Sc. Biotechnology student with strong academic background and hands-on training in Clinical Data Management (CDM). Seeking to contribute to a dynamic CDM team to ensure data quality and regulatory compliance.

Area of Interest

  • Pharmacovigilance, Clinical Data Management and Clinical Research.
  • Regulatory affairs related to clinical trials and pharmacovigilance (ICH-GCP, FDA, EMA guidelines).

Education

  • M.Sc Biotechnology

    Modern College of Arts, Science and Commerce, Pune – Savitribai Phule Pune University – 2025
  • B.Sc Biotechnology

    Mahatma Gandhi Mission, Aurangabad – Dr. Babasaheb Ambedkar Marathwada University – 2023 – 69.77%
  • Intermediate (10 + 2)

    Vidyadham College – Maharashtra education of secondary and higher secondary – 2019 – 54.77%
  • High School (10th)

    Anant Bhalerao Vidya Mandir – State Board – 2017 – 74.80%

Project Work

  1. Isolation, Identification and Antifungal Activity Of Air Microflora in Microbiology laboratory.
  2. Structure-based drug discovery: screening natural compounds for BACE1 inhibition in Alzheimer’s disease.

Clinical Data Management Training

  • Biotecnika – Online CDM Certification Program
  • Trained in ICH-GCP, regulatory guidelines, and CDM lifecycle.
  • Practical experience in data entry, discrepancy management, and working with EDC tools.
  • Exposure to SDTM/CDASH standards and SAE reconciliation.

Internship Experience

  • GREENARRAY – Genomic Research & Solutions Pvt. Ltd.

    – Participated in genomic analysis tasks and lab-based experimentation.

    – Gained exposure to biotechnology techniques and research processes.

Workshop

  1. Workshop | Hands on training workshop on Molecular cloning at Agharkar Research Institute.
  2. Three Dimensions of Stem Cells- Drug Discovery, Drug Screening and Drug Delivery at Modern College.
  3. Molecular docking at SPPU.

Technical Skills

  • EDC Systems: Medidata Rave, Oracle InForm
  • Clinical Data Standards: SDTM, CDASH
  • CDM Processes: Data entry, query management and resolution, SAE reconciliation
  • Compliance & Regulations: ICH-GCP, 21 CFR Part 11
  • Database Activities: Clinical database design, User Acceptance Testing (UAT)

Strengths

  • Strong understanding of clinical research and data workflows
  • Quick learner and highly adaptable
  • Strong communication and interpersonal skills
  • Attention to detail and organizational abilities
  • Team collaboration and positive attitude
  • Excited to learn new things

Declaration

I hereby declare that the information provided above is true and correct to the best of my knowledge.

Place: Pune

Date:

Rohit Bodkhe

Skills: Pharmacovigilance, Clinical Data Management, Clinical Research, Regulatory Affairs, ICH-GCP, FDA, EMA Guidelines, EDC Systems, SDTM, CDASH, Database Activities, Compliance & Regulations



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Cover Letter:

**Rohit Bodkhe**
Kulshree PG, Laxman Nagar
Baner-Balewadi Road, Pune – 411045

**Hiring Manager**
Panacea Medical Technologies Pvt. Ltd.
Malur, Kolar District
Dear Hiring Manager,
I am writing to express my strong interest in the Clinical Research Associate position at Panacea Medical Technologies Pvt. Ltd. , as advertised. With a Master’s degree in Biotechnology and focused training in clinical data systems, regulatory standards, and data quality assurance, I am enthusiastic about contributing to your team and ensuring excellence in clinical data processes.
During my CDM training with Biotecnika, I gained practical experience in Electronic Data Capture (EDC) tools such as **Medidata Rave** and **Oracle InForm**, as well as a solid understanding of **ICH-GCP** guidelines, **query management**, and **SAE reconciliation**. My hands-on exposure to **SDTM/CDASH standards** and user acceptance testing has equipped me with the necessary skills to support clinical trials from a data integrity and compliance standpoint.
Academically, I have completed a Bachelor’s degree in Biotechnology and am also completed my Master’s at Modern College, Pune. My background also includes project work in antifungal microbiology and structure-based drug discovery, further strengthening my analytical and research skills.
Beyond technical abilities, I bring a positive attitude, strong communication skills, and a collaborative spirit—qualities that I believe are vital in cross-functional clinical teams. I am a quick learner, eager to apply my knowledge to real-world CDM processes while continuing to grow professionally.
I would welcome the opportunity to discuss how my background, training, and enthusiasm align with your team’s needs. Thank you for considering my application. I look forward to the possibility of contributing to your organization’s success.
Sincerely,
**Rohit Bodkhe**

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