Carmen On

Key Achievements: Implemented a comprehensive tracking system to monitor key milestones, resulting in 30% more accurate resource forecasting and a 25% reduction in project delays.

• Portfolio Oversight: Successfully managed a portfolio of 35 studies, providing strategic oversight and reporting that led to a 20% improvement in project outcomes and stakeholder satisfaction.
• Stakeholder Communication: Provided detailed project status updates to stakeholders and executive management.
• Meeting facilitation: Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
• Change Management: Directed changes to project scope and cost and implemented appropriate change management processes to keep project on track.
• Contract Management: Monitored contracts and service level agreements to identify potential risks and implement mitigation actions to protect development process from unforeseen delays and costs.
• Client Service & Relationship Management: Provided outstanding service to clients through effective communication and prompt issue resolution to facilitate future business opportunities.
• Client Liaison: Acted as the primary escalation point between clients and the company, effectively resolving critical issues and enhancing client relationships, which led to a 20% increase in client satisfaction.
• Project Management & budgeting: Streamlined project tasks, performance, and budget management, achieving a 30% improvement in overall project delivery efficiency and timely completion of key milestones.
• Project planning and Client and Vendor Negotiation: Collaborate and successfully negotiated project scope and timelines with sponsors and stakeholders, aligning expectations and reducing project scope changes by 20%.
• Presentation: Coordinated and delivered high-impact presentations of project materials at internal and external meetings, resulting in increased stakeholder buy-in and project support.
• Reporting: Generated detailed project management reports for clients and management, leading to data-driven decisions that improved project success rates by 15%.
• Resource Strategy: Implement strategies to achieve project goals.
• Risk Management: Developed and executed contingency plans and risk mitigation strategies, ensuring a 95% success rate in project delivery despite unforeseen challenges.
• Training and Support: Trained and mentored new Project Managers, facilitating team training on therapeutic, protocol-specific, and process-related topics, which enhanced team performance and project quality by 20%.
• Team Collaboration: Collaborated with cross-functional teams to resolve project issues and mitigate risks, enhancing overall project efficiency and outcomes.
• Process Improvement: Actively participated in cross-functional initiatives and global process improvements, driving a 15% increase in operational efficiency and project success.

Key Achievements: Identified Vendor Data transfer review process issue and implemented change, leading to a 30% reduction in rework for the Stats group downstream.

• Primary Contact: Successfully served as the primary point of contact for internal and external teams, facilitating efficient communication and ensuring timely resolution of data management-related queries, leading to a 15% reduction in project delays.
• Project Tracking: Monitored milestones, tasks, and budgets for assigned projects, consistently achieving or exceeding project timelines and staying within budget, contributing to a 20% increase in client satisfaction.
• Communication: Proactively updated stakeholders on data management deliverables, resulting in improved project transparency and reduction in last-minute changes or issues.
• Resource Forecasting: Accurately forecasted units, hours, and resources required for data management tasks, optimizing resource allocation and reducing project costs by 12%.
• Risk Management: Conducted thorough risk analyses and developed effective mitigation strategies, successfully preventing potential project disruptions.
• Documentation: Authored comprehensive data management plans, data transfer specifications, interim lock plans, database closure, and unlocking plans, contributing to a 100% audit pass rate and enhancing overall data integrity.
• Audit: Played a key role in client and third-party audits, leading to successful audit outcomes with zero critical findings and strengthening client trust and compliance adherence.
• Bid Support: Contributed to bid and proposal development and participated in bid defense meetings.
• Training: Mentored and trained data management team members, increasing team efficiency by 25% and promoting a culture of continuous learning and professional growth.
• Scope Management: Effectively identified and managed out-of-scope activities, minimizing scope creep and safeguarding project budgets by maintaining a clear focus on deliverables.
• Conflict resolution: Successfully resolved team member conflicts through active listening and effective mediation, fostering a collaborative work environment and reducing turnover by 15%.
• Recruitment & Mentorship: Recruited, interviewed, and hired top talent, implementing a mentoring program that increased employee engagement by 40% and significantly boosted team morale.
• Budget & Resource Management: Successfully managed budgets and allocated resources to maximize productivity and profitability.

Key Achievements: Developed and implemented project tracking tools which enabled management to obtain study updates quickly (80% time saving).

• Project Planning: Developed and managed comprehensive project plans in collaboration with sponsors and stakeholders, ensuring alignment with business goals and resulting in a 95% on-time project delivery rate.
• Project Management: Successfully managed 30 Data Management projects concurrently, delivering regular updates to senior stakeholders, which enhanced decision-making and improved project success rates by 20%.
• Bids and Proposals: Contributed to bids and proposal development, securing new contracts valued at over $2 million.
• SOP Compliance: Ensured team adherence to company and sponsor SOPs, leading to a 100% compliance rate in internal and external audits.
• Mentorship and Resourcing: Mentored less-experienced Project Data Managers, improving their competency by 30% and accurately assessing resource needs to avoid project bottlenecks.
• Sponsor Relationship Management: Effectively managed sponsor relationships, triaged issues promptly, and ensured performance remained within budget and delivery requirements, leading to a 98% client satisfaction rate.
• Scope Management: Documented and approved scope changes through formal change management processes, minimizing scope creep and preserving project budgets and timelines.
• Team Leadership: Led cross-functional teams, addressed cohesion issues, and drove project success, resulting in a 25% improvement in team collaboration and overall project outcomes.
• Audits: Played a critical role in Sponsor and Regulatory audits and inspections, contributing to successful audit outcomes with zero major findings.
• Cross Functional collaboration: Collaborated effectively with multi-functional roles, ensuring communication and alignment in development efforts, which reduced project delays by 15%.
• Organizational & Time Management: Demonstrated strong organizational and time management skills, successfully managing multiple projects simultaneously and consistently meeting deadlines.
• Problem solving & Analysis: Identified issues, conducted thorough analyses, and provided solutions that resolved problems quickly, reducing project downtime by 20%.
• Efficiency & Deadline Management: Managed time efficiently, completing all tasks within deadlines, contributing to a 30% reduction in project turnaround time.

Key Achievements: Identified inefficiencies and Implemented New Data Management Process. In return, data quality improved by 50% and database lock was completed a lot earlier (2 months’ time saving)

• Regulatory Compliance: Ensured all data adhered to PMI SEND library standards for regulatory submissions, resulting in 100% compliance and smooth submission processes, significantly reducing the risk of regulatory delays.
• Cross-Functional Coordination: Collaborated closely with study directors, database programmers, and project staff to develop and maintain data management systems that consistently met study requirements, leading to a 20% improvement in data accuracy and reliability.
• Database Lifecycle Management: Oversee the entire lifecycle of Non-Clinical Data Management databases, overseeing data capture workflows, quality control through verification and audits, database lock, and data extraction. This comprehensive approach reduced data errors by 25% and ensured timely delivery of high-quality datasets to statisticians and relevant staff.
• SEND Library Expertise: Served as the subject matter expert for the SEND standard library, providing critical insights and guidance that enhanced the team's understanding and application of the standards, improving overall data submission quality by 15%.
• Documentation: Authored detailed data management plans, data validation plans, and SOPs/WKIs, which were instrumental in standardizing processes and improving the consistency and efficiency of data management operations across the organization.

Key Achievements: Successfully co-lead the EDC process Re-design initiative for initiation of new EDC RAVE database and was awarded 2 x STAR Award for courage and Quality certificates.

Direct reports: 2 Study Managers, and 2 Clinical Data Coordinators.

Computer Software used: EDC – RAVE, BOXI reporting, System Architect, Learning management System (LMS)

• Team Management: Assigned and prioritized work, mentored, and trained direct reports.
• Recruitment: Led recruitment efforts for new staff, successfully filling key roles with top talent, which enhanced team capabilities and contributed to a 25% improvement in project outcomes.
• Project Leadership: Oversaw internal and outsourced studies, ensuring strict adherence to data management standards across projects, which resulted in a 20% reduction in data discrepancies and faster project completion.
• Vendor Management: Reviewed RFPs, forecasted timelines, and proactively addressed potential issues for outsourced studies, leading to smoother vendor collaborations and a 15% reduction in project delays.
• Timeline and Deliverables: Defined and managed timelines, deliverables, and performance across study teams, external vendors, and CROs, achieving a 95% on-time delivery rate and ensuring all project milestones were met.
• Support and Guidance: Provided support and guidance to Study Data Managers, ensuring alignment with project decisions and standards, which improved overall project coherence and reduced deviations.
• Training and Mentorship: Conducted training, mentoring, and peer reviews within data management team which resulted in fast onboarding of new team members.
• Negotiation: Successfully negotiated timelines and set priorities, resulting in optimized project schedules and a 10% reduction in time-to-completion for key tasks.

Key Achievements: Developed and implemented operational support for New Electronic Data capture system - Macro which enabled users to have clear guidelines to set up and perform study conduct with less delay to study database lock.

Computer software used: Oracle Clinical, Macro, Clinical Trial Management system (CTMS), Hyperion reporting tool.

• CRF Design: Provided critical input on design of Case Report Forms (CRFs) and data entry guidelines, leading to 20% reduction in data entry errors and streamlining data collection processes.
• Kick-off Meetings: Actively participated in kick-off meetings, contributing to discussions on trial logistics, timelines, and data delivery expectations, which ensured all stakeholders were aligned, reducing project start-up time by 15%.
• Training: Chaired and presented data management training at study and vendor meetings, resulting in understanding and adherence to data management protocols.
• Documentation: Develop and maintain study-specific Data Management documents.
• Database Design: Supported database design and User Acceptance Testing (UAT), which led to successful launch of error-free databases, enhancing data quality and minimizing post-launch fixes.
• Presentation: Delivered impactful presentations at monitor workshops and investigator meetings, improving communication and alignment, leading to a 20% improvement in data management efficiency.
• Protocol Review: Reviewed and provided input on data management sections of protocols, ensuring clarity and accuracy, which reduced protocol deviations by 15%.
• Coding and Reconciliation: Oversaw coding, reconciliation, and quality checks.
• Discrepancy Resolution: Identified and resolved data discrepancies according to agreed workflows, reducing resolution times by 25% and enhancing overall data integrity.
• Data Close-Out: Coordinated data close-out activities, including data locking and freezing, which ensured timely project completion and facilitated smooth transitions to final analysis phases.

Key Achievements:

- Awarded first crystal impact award for outstanding performance in organizing team building exercise to forge links with Anti-infective teams.

- Awarded Second crystal impact award for achieving Database release on time with exceptional clean data both for paper studies & electronic studies.

Direct reports: 2 Data entry and 4 Clinical data coordinators.

Computer software used: Clintrial 3 & 4, CT-GSK, RDM, Remote Dictionary, ClinPhone, CPMS, RDMS, ResultsView, MIMS, LN Dictionary database, SQL, Medline, Martindale, SQLPLUS and ClinTrial 4.

• Study Design: Designed and set up studies for CT4 trials, leading to a 20% improvement in study setup efficiency and enhanced alignment with protocol requirements.
• CRF Review: Validated and audited both paper and electronic Case Report Forms (CRFs), ensuring data accuracy and compliance, which resulted in 15% reduction in data discrepancies.
• Validation Systems: Reviewed and assessed computerized validation systems.
• CRF Tracking: Managed tracking of European CRFs for return to Data Management in coordination with CRAs.
• Problem Solving: Identified, interpreted, and resolved data issues effectively, leading to 20% decrease in data-related delays and enhancing overall data quality.
• AE Reconciliation: Reconciled Serious Adverse Event listings from Central Safety Serious Adverse Events Database.
• Protocol Evaluation and Program updates: Evaluated protocols against CRF and Data Validation System (DVS) checks, implementing necessary program updates that enhanced validation processes and improved data integrity by 20%.

Key Achievements: Identify efficiencies and implemented the use of contract resource database for evaluating the cost-effective bids for Outsourcing clinical operations. (40% time saving and 30% reduction on cost).

• Supplier Liaison: Liaise with suppliers and Pfizer departments to compile and maintain an overview of suppliers used by Clinical.
• Template Development: Develop standard templates and associated databases to support outsourcing operations.
• Feedback Repository: Develop a repository for supplier performance feedback.
• Working Groups: Contribute to appropriate working groups to address approaches to resourcing management
• Bid Evaluation: Assess and guide on CRO bid selections specific to Data management and Clinical Operations.
• Data Analysis: Analyzed customer data to identify trends and anticipate customer needs.

• Key achievements: Evaluated and implemented a new Packaging record documentation system, achieving a 50% reduction in processing time and a 25% decrease in paperwork, which significantly streamlined operations and increased efficiency.

Direct reports: 3 Supervisor and 5 operators

Internal Computer software used: ADLS, CTS Packaging & labeling database, Materials management database, Expiry date database.

• Recruitment: Recruitment: Liaised with agencies to identify, interview, and recruit candidates, successfully filling key positions and reducing time-to-hire by 30%.
• Packaging Coordination: Scheduled and managed packaging timelines for clinical supplies, ensuring on-time delivery and a 20% reduction in packaging delays.
• Label Approval: Approved labeling information for patient supplies, maintaining 100% compliance with regulatory requirements and reducing label errors by 15%.
• Contract Coordination: Oversaw activities with contract packagers and CROs, ensuring targets were met and project milestones achieved.
• Quality Management: Investigated quality alerts and customer issues, assisting in packaging audits, which resulted in a 25% reduction in quality-related incidents and improved overall product quality.
• Performance Management: Provided feedback, coaching, and mentoring to team members.
• Process Improvement: Contributed to continuous improvement initiatives and updated SOPs, leading to a 15% increase in process efficiency and consistency.
• Coordination: Aligned activities with CRAs, Manufacturing, Project Teams, Clinical, and Quality Assurance, ensuring seamless integration and timely project completion, which improved cross-functional collaboration.

Final Year Project: An evaluation of the physiochemical properties of Paracetamol from branded formulations versus generics.