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I am Abubakar Sani, a results-driven Clinical Operations professional with 5+ years of progressive experience in biotech and pharma. I specialize in cross-functional study coordination, CRO/vendor oversight, and rigorous regulatory compliance (ICH-GCP). I excel at managing complex project timelines, driving operational excellence, and ensuring data quality across multi-center clinical trials. I bring a strong focus on clinical documentation, regulatory filing, and risk mitigation strategies, working effectively with global teams to align on timelines and deliverables. Fluent in English and German, I’m passionate about contributing to patient-centric trials and advancing therapies through meticulous operations and compliant practices.…I am Abubakar Sani, a results-driven Clinical Operations professional with 5+ years of progressive experience in biotech and pharma. I specialize in cross-functional study coordination, CRO/vendor oversight, and rigorous regulatory compliance (ICH-GCP). I excel at managing complex project timelines, driving operational excellence, and ensuring data quality across multi-center clinical trials. I bring a strong focus on clinical documentation, regulatory filing, and risk mitigation strategies, working effectively with global teams to align on timelines and deliverables. Fluent in English and German, I’m passionate about contributing to patient-centric trials and advancing therapies through meticulous operations and compliant practices.

ABUBAKAR SANI

Project Manager, Data Analyst, Data Scientist, +2

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I am Abubakar Sani, a results-driven Clinical Operations professional with 5+ years of progressive experience in biotech and pharma. I specialize in cross-functional study coordination, CRO/vendor oversight, and rigorous regulatory compliance (ICH-GCP). I excel at managing complex project timelines, driving operational excellence, and ensuring data quality across multi-center clinical trials. I bring a strong focus on clinical documentation, regulatory filing, and risk mitigation strategies, working effectively with global teams to align on timelines and deliverables. Fluent in English and German, I’m passionate about contributing to patient-centric trials and advancing therapies through meticulous operations and compliant practices.…I am Abubakar Sani, a results-driven Clinical Operations professional with 5+ years of progressive experience in biotech and pharma. I specialize in cross-functional study coordination, CRO/vendor oversight, and rigorous regulatory compliance (ICH-GCP). I excel at managing complex project timelines, driving operational excellence, and ensuring data quality across multi-center clinical trials. I bring a strong focus on clinical documentation, regulatory filing, and risk mitigation strategies, working effectively with global teams to align on timelines and deliverables. Fluent in English and German, I’m passionate about contributing to patient-centric trials and advancing therapies through meticulous operations and compliant practices.

Available to hire

I am Abubakar Sani, a results-driven Clinical Operations professional with 5+ years of progressive experience in biotech and pharma. I specialize in cross-functional study coordination, CRO/vendor oversight, and rigorous regulatory compliance (ICH-GCP). I excel at managing complex project timelines, driving operational excellence, and ensuring data quality across multi-center clinical trials.

I bring a strong focus on clinical documentation, regulatory filing, and risk mitigation strategies, working effectively with global teams to align on timelines and deliverables. Fluent in English and German, I’m passionate about contributing to patient-centric trials and advancing therapies through meticulous operations and compliant practices.

Language

English

Advanced

German

Advanced

Work Experience

Disclosure Manager at Staburo GmbH

May 1, 2024 - Present

Managed project execution for global disclosure compliance (EMA Policy 0070), coordinating across Data Management, Biostatistics, and Regulatory teams. Served as the central point of contact for multiple global study teams, tracking deliverables and resolving cross-functional operational issues. Authored and maintained international clinical trial registry records (ClinicalTrials.gov, CTIS, EU CTR), managing regulatory timelines to ensure submissions met global compliance requirements. Conducted qualitative and quantitative risk assessments to evaluate re-identification risks and supported QC review of study documents (protocols, CSRs).

Clinical Project Assistant at T-knife Therapeutics

January 1, 2023 - April 1, 2024

Supported operational planning and execution of a multicentre Advanced Therapy Medicinal Product (ATMP / cell therapy) clinical trial across 20+ global sites. Tracked deliverables, milestones, and study timelines; escalated operational risks to leadership for timely mitigation. Coordinated vendor and CRO activities, ensuring adherence to contracted scope, quality expectations, and critical timelines. Contributed to essential study documentation including monitoring plans, site manuals, and SOPs.

Clinical Trial Assistant (Intern) at Klinikum rechts der Isar

October 1, 2020 - June 1, 2021

Provided site-level clinical operations support including patient recruitment tracking, visit scheduling, and supply management. Managed regulatory documents, prepared TMF/ISF updates, and supported IRB/EC submissions. Assisted with safety reporting, query resolution in EDC systems, and maintained strict adherence to ICH-GCP.

Junior Clinical Research Associate at UNOCASA Ltd

January 1, 2018 - October 1, 2019

Conducted onsite and remote monitoring visits (SQV, SIV, MVs, COVs), ensuring full ICH-GCP and protocol compliance for infectious disease and oncology trials. Performed Source Data Review and Verification (SDV), resolving data discrepancies and ensuring data accuracy across multiple sites. Collaborated with site staff to optimize site performance, maintain enrolment targets, and ensure essential document completeness.

Customer Service Representative at TotalEnergies

January 1, 2017 - December 1, 2017

Developed strong communication, stakeholder management, and organizational skills in a high-pressure environment.