Corina Dinica

Development Operational Excellence Vaccines Project Coordinator: January 2020 – May 2021.

Global Clinical Operations Inspection Readiness Project Coordinator: January 2019 – December 2019.

• Global Clinical Objectives:

Managed execution of clinical sample testing strategies for five global clinical trials, including the most complex and challenging studies within the Vaccines Business Unit, achieving 100% on-time delivery of samples.

Reviewed and refined clinical trial lab manuals, and created Serology Plans to ensure alignment with global clinical development objectives.

Oversaw the meticulous management of clinical samples throughout their lifecycle, ensuring compliance with GCP-ICH guidelines.

• Cross-Functional Collaboration and Stakeholder Management:

Led clinical trial team meetings, proactively identifying and mitigating risks, while harmonizing timelines for successful study completion.

• Lab Manual Review and Implementation:

Ensured compliance with regulatory requirements through oversight of lab manual reviews and integration of Serology Plans into study protocols, in partnership with Clinical Operations.

• Vendor and Contract Management:

Drafted and executed contracts with bio-analytical vendors, ensuring alignment with Serology Plans, and efficient resource utilization.

• Budget Oversight:

Controlled clinical sample testing budgets, applying strong financial acumen to ensure cost-effective resource management.

• Quality Assurance Collaboration:

Identified and reported quality deviations, supporting corrective actions to maintain regulatory compliance and quality standards.

• Sample Lifecycle Leadership:

Managed distribution logistics and vendor coordination for bioanalytical testing, ensuring adherence to GCP-ICH guidelines and documentation integrity.

• Status Reporting:

Provided regular updates to clinical teams regarding project status and timelines, promoting transparency.

• Regulatory Compliance & TMF Management:

Maintained Trial Master File (TMF) integrity, conducting quality checks on clinical study documents to ensure regulatory adherence.

• Clinical Project Management:

Actively contributed to pivotal Phase 3 studies involving 20,000 participants across 7 countries, and Phase 4 post-authorization studies involving 70,000 participants.

Prepared the Clinical Bioanalysis function for regulatory inspections, demonstrating strong regulatory knowledge.

• Operational Excellence:

Implemented document management systems, enhancing workflow efficiency and accuracy across functions.

• Training & Development:

Established training matrix and logs for team members, and developed Best Practice Guides for documentation processes.

• Quality Compliance Oversight:

Ensured compliance for clinical trials and the electronic Trial Master File (eTMF), achieving a 100% compliance rating during audits.

• Informed Consent Analysis:

Conducted a thorough analysis of 400 unique Informed Consent Forms for vaccine studies, and developed recommendations for compliance enhancement.

Key Competencies:

• Expertise in Clinical Trial Management and Operations.
• Strong regulatory knowledge and adherence to GCP-ICH guidelines.
• Effective communication and stakeholder management skills.
• Financial and budget management proficiency.
• Quality assurance and compliance oversight.
• Proficient in project management and operational excellence.

• Sales Growth: Expanded market reach through innovative sales strategies.
• Client Focus: Utilized consultative sales to understand needs, and develop tailored solutions.
• Performance Leadership: Supervised sales reports and forecasts, driving strategic decision-making.
• Relationship Building: Cultivated strong relationships with internal and external stakeholders.
• Account Management Excellence: Prioritized client needs, and enhanced account management practices.
• Market expertise: Leveraged research to understand customer needs and analyze competitor positioning.
• Collaborative Team Player: Fostered a collaborative team environment.
• Negotiation Expert: Secured optimal terms in agreements with external partners.

• Key Account Management: Drove retention and growth for top-tier clients, ensuring long-term partnerships.
• Client Value: Collaborated to identify needs and deliver maximum value through expert consulting and solutions.
• Campaign Optimization: Utilized advanced tools to manage and optimize campaigns for customer satisfaction and renewals.
• Process Adherence: Ensured compliance and efficiency across all client interactions.
• Client Success Focus: Championed sustainable business growth through exceptional service and issue resolution.