Clinical Data Project Management

ASHWINI ANEY MATE

+23-320-****-*** *******.*****@*****.***

LinkedIn: https://lnkd.in/dHxaAqD9

SUMMARY

An accomplished professional with over 15 years of experience in the pharmaceutical sector, skilled in areas such as Regulatory Affairs, Quality Assurance, and Project Management, with a strong focus on Drug Development and Clinical Research.

Expertise in managing end-to-end regulatory processes, including product registration, compliance monitoring, and submission of variations and renewals across multiple regions, notably in Africa.

Proficient in leading cross-functional teams to deliver on large-scale projects, ensuring strict adherence to clinical standards and operational procedures within the industry.

Certified Six Sigma Black Belt, leveraging process improvement methodologies to enhance data integrity, reduce discrepancies, and optimize overall operational efficiency.

Proven track record in training and developing regulatory teams, enhancing departmental capabilities, and establishing robust data management systems like InForm, RAVE, and Epi Info. KEY SKILLS

Regulatory Affairs Management Project Management Drug Development Data Management EDC System Management

(InForm, RAVE, Epi Info) Quality Control Document Review and Compliance Team Recruitment and Training Stakeholder Communication and Coordination Problem-Solving and Process Improvement Six-Sigma Methodologies Data Integrity and Reconciliation Risk Management Planning Compliance Monitoring Regulatory Submissions Standard Operating Procedures

Variation Filing

WORK EXPERIENCE

Assistant Regulatory Manager Unichem Industries Ltd, Ghana Jan 2022 - Present Clinical Data Reviewer Cactus Communication, India Oct 2014 - Sep 2017 Associate Clinical Data Manager Tata Consultancy Services, India Oct 2013 - Oct 2014 Senior Clinical Data Manager Vedic Life Sciences, India June 2011 - Sep 2013 Senior Clinical Data Manager Cognizant Technology Solution, India Jan 2009 - Apr 2011 Clinical Data Manager Tata Consultancy Services, India May 2007 - Jan 2009 As an Assistant Regulatory Manager

Lead the Drug Regulatory Affairs department, overseeing regional competencies for Regulatory Services.

Collaborate with cross-functional teams to manage large-scale projects effectively.

Spearheaded the regulatory registration of a diverse range of products, including solid dosage forms, liquids, ointments, multivitamins, and herbal supplements.

Provide regulatory expertise to business teams, facilitating the launch and registration of new products across Africa.

Serve as the Regulatory Manager, responsible for timely registration of new products, filing variations, renewals, and coordinating with regulatory authorities.

Manage communications and coordination with internal and external stakeholders, addressing queries and ensuring compliance with regulatory requirements.

Oversee the recruitment and training of the Regulatory team, enhancing departmental capabilities.

Evaluate and review responses to queries raised by Regulatory Authorities, ensuring accuracy and regulatory compliance. As a Clinical Data Manager

Maintained quality control database standards and set study milestones, analyzing project requirements prior to departmental introductions.

Demonstrated expertise in project management with a strong background in drug development, data management, and regulatory deliveries in pharmaceutical R&D.

Proficient in EDC system management, including platforms such as InForm, RAVE, and Epi Info.

Developed and implemented alternative solutions, successfully establishing CDM and Regulatory departments, and led multiple training sessions in these areas.

Ensured project compliance with operational procedures and clinical standards.

Managed data activities according to CRF database design guidelines.

Documented data management processes, including CRF design, UAT testing, discrepancy management, and external data integration.

Handled AE/SAE data reconciliation, data locking, and study gap analysis, ensuring data integrity and regulatory compliance.

As a Quality Control Specialist

Reviewed regulatory and scientific documents, including Clinical Study Reports (CSRs) and Risk Management Plans (RMPs), ensuring compliance with regulatory standards.

Identified and corrected factual errors, and data inaccuracies, and conducted miscellaneous checks to maintain document integrity.

EDUCATION

Bachelor in Pharmacy 2007

Post Graduate Diploma in Clinico, Patent & Regulatory 2007 CERTIFICATIONS

Certified Six-Sigma Black belt from IACT Global 2015 LANGUAGES KNOWN

German - Pursuing B1

English - Upper-Intermediate

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