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Talya Saleem

@talyasaleem

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Clinical Research Professional with expertise in regulatory compliance.

Pakistan

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What I'm looking for

I am seeking a role that fosters collaboration, encourages innovation, and offers opportunities for professional growth in clinical research.

I am a Clinical Research Professional with over three years of experience in regulatory submissions, study start-up, and compliance, particularly within the realms of FDA, ICH-GCP, and DRAP. My academic background in neuroscience, complemented by hands-on experience in clinical research, has equipped me with a unique perspective on regulatory strategy and document management. I pride myself on being proactive, analytical, and collaborative, always striving for process improvement and effective cross-functional teamwork.

In my current role as a Regulatory Specialist at DynaMed Clinical Research, I prepare and submit regulatory documents for clinical trials, ensuring compliance with stringent guidelines. My previous experience as a Clinical Research Officer at Shaukat Khanum Memorial Cancer Hospital allowed me to manage clinical trial operations effectively, ensuring ethical compliance and protocol adherence. I have also contributed to product management in neuroscience, where I conducted market research and developed targeted content to enhance product visibility.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Specialist

Current

DynaMed Clinical Research

Mar 2024 - Present (1 year 3 months)

Prepared, reviewed, and submitted regulatory documents for clinical trials and amendments in compliance with FDA, ICH-GCP, and SOPs. Provided regulatory support during study start-up, conduct, and close-out, including review of study protocols, informed consent forms, and other study documents. Managed global submissions including pre-submissions, INDs, and amendments.

Regulatory Submissions FDA ICH GCP SOPs Clinical Trials Risk Mitigation Document Management

Clinical Research Officer

Shaukat Khanum Memorial Cancer Hospital and Research Centre

Jun 2023 - Present (2 years)

Reviewed and coordinated SRC and IRB submissions for oncology trials, ensuring regulatory and ethical compliance. Managed clinical trial operations including patient recruitment, informed consent, protocol adherence, and study visit scheduling per ICH-GCP. Prepared and maintained regulatory documentation, safety reports (AEs, SAEs, SUSARs), and study files per DRAP and institutional SOPs.

ICH GCP Regulatory Data Entry

Product Management for Neuroscience

2BScientific

Jan 2022 - Present (3 years 5 months)

Conducted market research on neuroscience and neurodegenerative trends to guide product strategy and content creation. Developed targeted web content and promotional materials in collaboration with cross-functional teams. Optimized product listings by disease focus, improving visibility and customer access.

Market Research Neuroscience Product Strategy Content Creation Content Promotional Materials Optimization Competitive Analysis

Education

Degrees, certifications, and relevant coursework

Universita Degli Studi Di Palermo

Masters in Neurosciences, Neurosciences

Grade: 101/110

Activities and societies: Spearheaded research on spatial manipulation in peripersonal space through immersive technologies. Organized research for the administration of tDCS and TMS to examine excitatory effect of Indicaxanthin. Assisted in patch-clamp experiment on neural cells and intra-operative monitoring during transcranial MR-guided Focused Ultrasound thalamotomy.

Completed a Master's degree focusing on Neurosciences. Conducted research on spatial manipulation using immersive technologies for pseudo-neglect syndrome treatment strategies.

University of Debrecen

Bachelors in Biological Sciences, Biological Sciences

Grade: 4.85/5.00 (Cum Laude)

Activities and societies: Investigated susceptibility tests for Aspergillus Fumigatus using different anti-fungal agents to identify potential treatments. Performed data analysis and formulated final report.

Obtained a Bachelor's degree in Biological Sciences with Cum Laude honors. Investigated susceptibility tests for Aspergillus Fumigatus using various anti-fungal agents.