Open to opportunities

devyani goyal

@devyanigoyal

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Enthusiastic Clinical Research Professional

India

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What I'm looking for

Seeking a challenging role in Clinical Research that leverages my skills and experience to contribute to team success, with opportunities for growth and professional development.

As a seasoned clinical research professional with over 11 years of experience, I have developed a strong understanding of regulations and guidance in the transparency domain. With a proven track record of delivering high-quality results efficiently, I excel in leading projects with minimal management oversight and tailoring communication to diverse audiences.

My expertise includes redaction and quality review for EMA Policy 0043, 0070, EU-CTIS, and HC-PRCI, as well as preparing Redaction Packages for Sponsors. I am well-versed in quality checks of CSR, Protocols, Synopsis, PSUR, and AE Reports, and have experience with automated tools for anonymization and redaction of clinical documents.

I possess excellent internal and external customer service, communication, leadership skills, and teamwork. I am motivated to learn, grow, and excel in the Clinical Research Industry, and I am eager to contribute to team success through hard work, attention to detail, and excellent organizational skills.

Experience

Work history, roles, and key accomplishments

Current

Senior Clinical Trial Transparency Specialist

Current

MMSH

Jan 2024 - Present (1 year 4 months)

As a Senior Clinical Trial Transparency Specialist, I lead projects ensuring compliance with transparency regulations, manage deliverables, and communicate effectively with diverse audiences. I focus on redaction and quality review for clinical trial documents, while maintaining timelines and project management.

Regulatory Compliance Project Management Redactions Quality Assurance Communication Team Leadership Customer Service Data Analysis

Clinical Trial Transparency Specialist II

MMSH

Jun 2022 - Jan 2024 (1 year 7 months)

In this role, I provided high-quality deliverables related to clinical trial transparency, conducted quality checks, and managed redaction processes for various regulatory submissions. I also developed project management skills and ensured compliance with regulatory timelines.

Clinical Trials Quality Redactions Project Management Communication Customer Service Regulatory Compliance Data Management

CDD & T Specialist

Icon GSS

May 2017 - Jun 2022 (5 years 1 month)

As a CDD & T Specialist, I managed the redaction process for public disclosure documents, communicated with reviewers, and led projects to identify process improvements. I utilized critical thinking and data analysis to enhance operational efficiency.

Redactions Data Analysis Project Management Communication Problem Solving Microsoft Excel Continuous Improvement Customer Service

Technical Document Operation Specialist

Icon GSS

Aug 2014 - Apr 2017 (2 years 8 months)

In this position, I performed system administration for clinical trials, managed data entry, and ensured the proper handling of essential documents. I coordinated communications and maintained metrics for document processing.

Data Entry Document Management Communication System Administration Regulatory Compliance Metrics Team Coordination

Clinical Research Coordinator

Apollo Hospitals Educational & Research Foundation

May 2012 - Jul 2014 (2 years 2 months)

As a Clinical Research Coordinator, I implemented trial protocols, managed subject enrollment, and ensured compliance with drug safety reporting. I coordinated with ethics committees and managed study documentation.

Clinical Research Implementation Project Management Communication