SHEBI SHIJU
Pune
Summary
An organised and dedicated professional with an extensive background in clinical operations, project management and regulatory compliance. Adept at team-coordination, metrics presentation and fostering strong client relationships. Demonstrated significant impact on improving efficiency of project delivery while maintaining compliance.
Overview
16
16
years of professional experience
Work History
Clinical Project Manager
Tata Consultancy Services Ltd.
Pune
01.2025 - Current
- Collaborate with Study Delivery/Asset Lead to manage clinical study plan that drives resources and budget.
- Manage clinical trial projects in Planisware from initiation to closure.
- Assure data quality for project plans and compliance with standards.
- Attend to queries and provide suggestions as subject matter experts to ensure project timelines and deliverables are met.
Assistant Manager - Clinical Operations
Tata Consultancy Services Ltd.
Pune
09.2019 - 12.2024
- Managed team schedules and ensured timely project completion, oversight of activities with operational excellence, and driving performance appraisals of the team.
- Developed process documentation and collaborated with customer stakeholders to streamline operational workflows within SAP Biorepository, Power BI Dashboards, and Veeva eTMF.
- Collaborated with management on developing strategic plans for achieving business goals.
- Co-ordination with customer for new business prospects and discussion on any challenges.
- Presentation of metrics to organizational and customer management.
- Implemented best practices for quality control (QC), and monitored defects by performing RCA-CAPA.
- Coordinated training sessions for new employees and facilitated onboarding process.
- Ensured inspection-ready process, and participated in audits.
Business Process Lead - Regulatory Affairs
Tata Consultancy Services Ltd.
Mumbai
12.2013 - 09.2019
- Ensured compliance with customer standards and published documents such as protocols, investigator's brochures, CTD modules, and clinical study reports (CSRs) for submission.
- Facilitated derivation of metrics for activities of the team.
- Mentored employees to align with company's core values, and 'first-time right' approach.
- Performed quality control checks prior to customer hand-off.
- Assisted with tracking defects and the rectification of documents that identify the need for quality responses.
Process Executive - Regulatory Operations
Tata Consultancy Services Ltd.
Mumbai
03.2012 - 12.2013
- Reviewed, quality-checked, and published documents to meet regulatory standards and align with ICH requirements.
- Collaborated with medical authors to enhance publishing standards.
- Checked copyright clearance of literature references in Clinical Study Reports (CSRs).
- Managed documents in electronic document management system (eTMF), with audit trail.
Executive – Regulatory Affairs And Compliance
Goldshield Services Private Limited
Mumbai
06.2011 - 03.2012
- Developed submissions to EU and Irish regulatory authorities for marketing authorizations, change of ownership, license renewals, and application of variations (Type IA, IB, II) through the MHRA portal.
- Evaluated licenses for compliance with statutory requirements and regulatory guidelines.
- Updated product information (SmPC, PIL, and artwork for package labeling) for submission to the Regulatory Authorities.
- Oversee, record, and regulate defects in the manufacturing of allocated products, along with the Quality Assurance team.
- Record documentation of regulatory submissions in the electronic document management system.
Process Executive – Regulatory Affairs
Cipla Limited
Mumbai
11.2009 - 06.2011
- Dossier preparations and registration of formulations in Southeast Asia, the Middle East region, and the Pacific Islands according to the regulatory guidelines.
- Coordinated with cross-functional teams, such as pharmaceutical manufacturing sites, the Bioequivalence team, the Legal department, and the International marketing departments, for regulatory compliance.
- Provided legal, medical, and technical documents with samples while handling tenders for markets from the Pacific Islands.
Education
Master of Sciences - Biochemistry
Seth G S Medical College & KEM Hospital
MumbaiBachelor of Sciences - Life Sciences & Biochemistry
St. Xavier's College
MumbaiSkills
- Veeva eTMF
- Clinical Trial Management System (CTMS)
- SAP (bio-sample management)
- Power BI dashboards
- Planisware
- Regulatory compliance
- Project management
- Client relationship management
- Team coordination
- Metrics presentation
- Performance appraisal
- Process improvement strategies
- Operations management
- Critical thinking
- Attention to detail
- Detail-oriented
Accomplishments
- Received a customer satisfaction score of 100% in 2022 and in 2024 for maintaining efficiency and savings through process simplifications
- Led a team and collaborated with the customer for the migration of data for over 64 clinical studies into the new tracking system within six months
- Demonstrated and drove process improvements worth soft savings of £0.5 million for the customer
- Served as the 'subject matter expert' in automation projects for customer and business RFPs for human sample management
- Gained the title of a 'Contextual Master' for expertise in domain knowledge and savings for the customer
- Participated in customer and corporate quality assurance audits for the team
- Received TCS performance-linked rewards and star performer awards on several instances
- Completed the certification course on Managerial Fundamentals: Foundation
Timeline
Clinical Project Manager
Tata Consultancy Services Ltd.
01.2025 - Current
Assistant Manager - Clinical Operations
Tata Consultancy Services Ltd.
09.2019 - 12.2024
Business Process Lead - Regulatory Affairs
Tata Consultancy Services Ltd.
12.2013 - 09.2019
Process Executive - Regulatory Operations
Tata Consultancy Services Ltd.
03.2012 - 12.2013
Executive – Regulatory Affairs And Compliance
Goldshield Services Private Limited
06.2011 - 03.2012
Process Executive – Regulatory Affairs
Cipla Limited
11.2009 - 06.2011
Master of Sciences - Biochemistry
Seth G S Medical College & KEM Hospital
Bachelor of Sciences - Life Sciences & Biochemistry
St. Xavier's College
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