Summary
Overview
Work History
Education
Skills
Timeline
Generic

Susan Sieracki

Berwyn,PA

Summary

Experienced Project Manager and System Analyst with an extensive background in delivery of Clinical Systems, Investigator Initiated Study (Phase IV) Programs, GCP, ICH and Regulatory Requirements, Process/System Analysis and Development. Proven history of successful engagement across local and global cross-functional teams while managing multiple complex projects. Seeking a challenging role that provides growth in information management, clinical development, leadership and process development.

Critical thinking [Job Title] with proven success at driving software projects to meet business and user needs. Integrates technical and programming expertise with broad understanding of stakeholder requirements. Works under pressure and communicates concisely and clearly with customers, developers and management.

Systems professional with extensive experience delivering impactful solutions in technology sector. Known for fostering collaboration and driving projects to completion with focus on results. Reliable and adaptable, possessing strong analytical skills and deep understanding of system integration and process improvement.

Overview

21
21
years of professional experience

Work History

IM Lead - Clinical, Safety, Regulatory

Adaptimmune
11.2021 - Current
  • Manages the build and run of Clinical, Regulatory and Safety IT solutions and services
  • Consults and advises on IT capabilities and Clinical, Regulatory and Safety IT roadmap
  • Authors requirements, use cases, process flow documents with business stakeholders
  • Drives quality and scalability in IT business systems, ensuring efficient and effective operations
  • Ensures all IT services meet expectations and aligns to best practices in IT architecture, IT security, GxP compliance
  • Provides input in business case development, solution evaluation and selection
  • Develop and assist with User Training
  • Collaborated with cross-functional teams to ensure seamless integration of various project components.
  • Facilitated clear communication between internal departments, ensuring all parties remained aligned on goals throughout the duration of each project.
  • Partnered with project team members to identify and quickly address problems.
  • Ensured timely delivery of critical deliverables by closely monitoring progress against milestones and adjusting plans as necessary.
  • Enhanced client satisfaction by consistently delivering high-quality projects within budget and on schedule.
  • Mentored junior team members, fostering professional growth and increasing overall team efficiency.
  • Implemented best practices in documentation management systems that improved efficiency, accessibility, and security of project-related information.
  • Adapted project plans in response to changing requirements, minimizing disruptions to project timelines.
  • Provided technical support for end-users, resolving issues promptly and effectively.
  • Enhanced user experience through the implementation of interface updates and usability improvements.
  • Enhanced collaboration between IT teams by standardizing communication protocols around system requirements, project progress updates, and change management processes.
  • Conducted comprehensive system analyses to identify areas for improvement and optimization.
  • Developed detailed technical documentation to facilitate knowledge sharing among team members and aid in future troubleshooting efforts.
  • Implemented rigorous testing procedures to ensure optimal performance and minimize errors in software applications.
  • Collaborated with upper management to drive strategy and implement new processes.
  • Assessed business requirements to create focused solutions.
  • Improved system efficiency by analyzing and optimizing software processes.
  • Fostered a culture of continuous improvement within the organization by actively soliciting feedback from end-users on system performance and incorporating user suggestions into future development efforts.
  • Reduced downtime during system upgrades by developing thorough rollout plans that minimized potential disruptions to daily operations.
  • Improved systems with addition of new features and infrastructure.
  • Spearheaded data migration projects, ensuring seamless transfer of information between systems.
  • Gathered requirements and performed gap analysis through design workshops with users.
  • Analyzed existing systems and databases and recommended enhancements to solve business needs
  • Performed internal system acceptance to deliver well-tested enhancements and meet business requirements.
  • Troubleshot incidents reported by end-users to schedule system changes and identify permanent solutions.
  • Communicated and explained business requirements to team members to understand and implement functional demands.
  • Enhanced project management skills by defining and presenting system solutions and timelines for business needs or technical problems.
  • Oversaw document development across project workstreams to create internal control statements per compliance and regulatory standards.
  • Collaborated with cross-functional teams to develop system solutions tailored to business needs.
  • Collaborated with cross-functional teams to develop and implement effective IT solutions for business needs.
  • Created all troubleshooting documentation and distributed it to team members and key stakeholders.
  • Conducted thorough systems analysis to identify areas for improvement, leading to increased efficiency across the organization.
  • Assessed vendor proposals for new software implementations, ensuring alignment with company goals and budgetary constraints.
  • Maximized resource allocation through accurate capacity planning based on historical trends.
  • Escalated project-related issues quickly to help rectify problems and avoid delays.
  • Proactively identified potential risks associated with system changes by conducting thorough impact assessments.
  • Developed comprehensive training materials for end-users on various systems and applications, enhancing overall user competency levels.
  • Utilized different methods to troubleshoot software and hardware issues.
  • Established clear communication channels between IT departments and stakeholders, facilitating smooth project execution.
  • Managed multiple projects simultaneously, consistently meeting deadlines while maintaining high-quality results.
  • Provided comprehensive user support, resolving technical issues quickly to minimize disruptions.
  • Identified areas that could be improved through specific processes and addition of new software.
  • Participated in change management initiatives, supporting seamless transitions during technology upgrades or process overhauls.
  • Reduced downtime for critical business applications by proactively identifying and resolving system issues.
  • Developed and implemented workflow templates, prioritizing efficiency and ease-of-use for end-users of [Software].
  • Participated in risk assessment analysis for [Type] products, applying standard change control procedures to minimize inherent liability in software releases.
  • Held final approval for software versioning validation, providing oversight of pre-shipment [Software] revisions and updates.
  • Worked closely with business users and business analysts to understand functionality and propose creative solutions to meet business needs.
  • Balanced multiple projects by completing and updating documentation, managing scope and adjusting schedules.
  • Completed software development lifecycle from requirement analysis to test planning, test case development and test execution.
  • Performed user account maintenance tasks, archiving defunct credentials and monitoring login systems for suspicious trends.
  • Re-engineered existing computer systems to promote ease-of-use and improve system security.

Clinical Vendor Management Analyst

ICON (PRA Health Sciences)
06.2020 - 11.2021
  • Performs research and analysis of eCOA vendor experience and/or capabilities in support of new business opportunities and provides support for vendor selection, project specific vendor start up strategy (contracting timelines and budgeting), and coordination with proposal, clinical study project teams, and functional representatives on vendor processes and capabilities
  • Provides research and collaborates with project managers and selected eCOA vendors to ensure licensing and translation requirements
  • Defining process and data requirements for development and implementation of eCOA management system
  • Negotiated favorable contract terms with vendors to secure the best possible pricing and service levels for the company.
  • Partnered with legal teams in drafting contracts that protected company interests while maintaining positive vendor relationships.
  • Facilitated regular vendor review meetings to discuss performance issues, address concerns, and explore opportunities for process improvements.
  • Established clear performance metrics for vendors, enabling consistent monitoring of results and identification of opportunities for improvement.
  • Led contract negotiations with new vendors, securing advantageous terms that supported long-term business growth.
  • Identified potential cost savings through detailed analysis of spending patterns across multiple categories of goods and services provided by vendors.
  • Collaborated with cross-functional teams to optimize vendor selection criteria and ensure alignment with company objectives.
  • Enhanced vendor relationships by implementing effective communication strategies and addressing concerns promptly.
  • Streamlined vendor management processes, resulting in improved efficiency and reduced overhead costs.
  • Coordinated with various departments to establish clear expectations for vendor deliverables, streamlining internal workflows as a result.
  • Managed a diverse portfolio of vendors, ensuring timely delivery of products and services while maintaining high quality standards.
  • Developed strong partnerships with key vendors, fostering a collaborative environment for mutual success.
  • Evaluated current processes to develop improvement plans.
  • Reviewed internal systems and organized training plans to address areas in need of improvement.
  • Restructured procedures through coordination with compliance director to create and execute projects.
  • Fostered a culture of continuous improvement by actively seeking feedback from team members, implementing process enhancements based on lessons learned.
  • Reviewed vendor-provided documentation critically assessing their capabilities in meeting project expectations before engaging in collaborations or outsourcing activities.
  • Supported internal audits by providing necessary documentation related to validation efforts, ensuring compliance with established standards.
  • Managed change control initiatives ensuring that all system modifications underwent proper revalidation before implementation into production environments.
  • Led the training of junior team members on validation principles and techniques, fostering a culture of continuous learning within the organization.
  • Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.
  • Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed.
  • Improved validation processes by implementing risk-based approaches and streamlining documentation.
  • Participated in external audits conducted by regulatory authorities demonstrating a high level of expertise and preparedness during inspections.
  • Maintained excellent communication with stakeholders throughout validation projects, keeping them informed about progress and potential challenges.
  • Optimized resource allocation by prioritizing critical validations based on business needs and regulatory requirements.
  • Trained and assisted staff in validation techniques, methods and testing processes.
  • Documented entire validation process, noting changes or alterations completed.
  • Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
  • Collaborated on Standard Operating Procedure (SOP) development, incorporating input from [Type] team to reduce liability and enhance successful deployments.
  • Explained highly complex information in terms easily understood by non-technical personnel.
  • Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
  • Authored validation protocols for [Type] systems, verifying compliance with internal policies and external safety requirements such as [Area of Certification].
  • Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
  • Collaborated with cross-functional teams for identification and resolution of validation issues.
  • Demonstrated new product features and functionality to project stakeholders.
  • Produced and maintained technical documentation for project reference.
  • Met tight deadlines to satisfy client demands and project timelines.
  • Proposed development and testing improvements to positively impact usability, function and performance.

Senior Business Analyst

IQVIA
07.2019 - 11.2019
  • Elicits business requirements from Subject Matter Experts to author high quality design and functional specifications within an agile methodology, interacting with customers, professional services team, and sales to understand business needs, while also conducting market research and competitive analysis
  • Prepares application release related materials such as training materials and client User Acceptance Test materials, release notes, etc
  • And provides support to areas of the organization including: QA, Support, Professional Services, Marketing, and Sales
  • Created detailed user stories for system enhancements, leading to improved functionality and user satisfaction.
  • Facilitated requirement gathering workshops, resulting in clear project objectives and deliverables.
  • Improved project efficiency by analyzing business processes and identifying areas for improvement.
  • Conducted gap analyses to identify discrepancies between current and desired states, leading to actionable recommendations.
  • Supported leadership team with reporting, analysis, and business presentations to inform divisional strategies.
  • Streamlined workflow for better productivity with the implementation of new software solutions.
  • Led process mapping initiatives, resulting in optimized workflows and reduced redundancies across departments.
  • Collaborated with cross-functional teams, ensuring a cohesive approach to business analysis.
  • Enhanced stakeholder engagement through effective communication of complex data and insights.
  • Interacted with internal customers to understand business needs and translate into requirements and project scope.
  • Collaborated with stakeholders to identify business needs and data sources.
  • Generated ad-hoc reports to evaluate specific business requirements.
  • Developed customized reports, summarizing and presenting data in visually appealing format.
  • Created dashboards to monitor and track key performance indicators.
  • Generated standard and custom reports to provide insights into business performance.
  • Developed and implemented data governance policies and procedures.

System Analyst

PRA Health Sciences
02.2018 - 07.2019
  • Supported the design, development, implementation, testing, validation, documentation, review and maintenance of enterprise applications for Johnson and Johnson, provided expertise to internal and external clients in support of all phases of the System Development Life Cycle, and evaluated new or updated products and services for all areas of Clinical Development
  • An in depth understanding of clinical business functions and systems was needed to determine the impact of system and process changes and provide appropriate recommendations and communications to stakeholders, as well as coordinating and participating in initiatives to develop, test and implement system changes, integration, upgrades and patches
  • Collaborated with cross-functional teams to develop system solutions tailored to business needs.
  • Provided technical support for end-users, resolving issues promptly and effectively.
  • Enhanced user experience through the implementation of interface updates and usability improvements.
  • Enhanced collaboration between IT teams by standardizing communication protocols around system requirements, project progress updates, and change management processes.
  • Developed detailed technical documentation to facilitate knowledge sharing among team members and aid in future troubleshooting efforts.
  • Improved system efficiency by analyzing and optimizing software processes.
  • Fostered a culture of continuous improvement within the organization by actively soliciting feedback from end-users on system performance and incorporating user suggestions into future development efforts.
  • Performed internal system acceptance to deliver well-tested enhancements and meet business requirements.
  • Troubleshot incidents reported by end-users to schedule system changes and identify permanent solutions.
  • Communicated and explained business requirements to team members to understand and implement functional demands.
  • Enhanced project management skills by defining and presenting system solutions and timelines for business needs or technical problems.

Product Manager

ePharmaSolutions
02.2013 - 09.2014
  • Responsible for establishing user stories, use cases, process flows, data requirements, etc
  • For clients and core products
  • Conducted marketplace research including meeting with customers on desired feature sets and reviewed industry guidelines, specifications, and regulations
  • Led the oversight of ePharmaSolutions’ Technical Publications team which produces user documentation, administrator documentation and validation materials and provided internal and external facing communication/presentations
  • Communicated effectively with team members to deliver updates on project milestones and deadlines.
  • Developed product documentation to communicate upcoming features and products to internal teams.
  • Collaborated with sales teams to develop effective training materials that drove increased product knowledge among staff members, resulting in higher close rates.
  • Coordinated design meetings and decisions with internal departments and teams.
  • Collaborated with sales, marketing, and support teams to launch products on time and within budget.
  • Maintained positive vendor relations to build strong partnerships.
  • Documented user stories, specifications, and product features into detailed work order to communicate across teams and build mandatory requirements.
  • Managed stakeholder expectations effectively throughout the entire product development process.
  • Prioritized roadmap in order to achieve product goals and metrics.
  • Thrived in fast-paced, highly-adept team to develop and prioritize product features and build product roadmap.
  • Liaised with clients to better understand business needs and current market landscape.
  • Coordinated project planning and execution with team members and team leads.
  • Managed product demonstrations and testimonials for performance evaluation.
  • Continuously monitored customer feedback channels after launch to gather insightful data for future iterations or updates.
  • Led cross-functional teams to deliver high-quality products on time and within budget constraints.
  • Spearheaded the creation of detailed user guides for enhanced usability of newly launched products.
  • Led cross-functional teams to deliver new product features on schedule, fostering collaboration between engineering, marketing, and sales departments.
  • Fostered culture of innovation, encouraging team members to propose and pursue new ideas for product enhancement.
  • Increased customer satisfaction, gathering and incorporating extensive user feedback into product improvements.
  • Drove innovation within product line, identifying and pursuing opportunities for new features and enhancements.

Clinical Business Process Analyst

Shire/Kelly Services
09.2013 - 12.2013
  • Contract position to analyze system and process issues for Clinical Trial Management System associated with Monitoring visit reports and provide process improvements, identifying bug fixes and system enhancements
  • Designed reports providing metrics to support and improve operations, partnerships, new and ongoing initiatives, and strategic decision making
  • Developed, wrote, and published training materials
  • Established strong relationships with internal clients to better understand their needs and expectations related to process improvements.
  • Performed root-cause analysis on recurring issues within existing processes, identifying solutions that addressed underlying causes effectively.
  • Collaborated with cross-functional teams to develop optimized business processes, resulting in improved collaboration and communication.
  • Provided ongoing support to team members during transition periods following process updates, minimizing disruption and maintaining productivity levels.
  • Assessed business processes and identified ways to boost improvement.
  • Facilitated training sessions for employees on newly implemented processes, ensuring seamless adoption across the organization.
  • Built strong relationships with customers through positive attitude and attentive response.
  • Assisted with new hire processing and existing training programs.
  • Analyzed data to identify root causes of problems and recommend corrective actions.
  • Generated ad-hoc reports to evaluate specific business requirements.
  • Generated standard and custom reports to provide insights into business performance.
  • Provided technical support for troubleshooting analytics and reporting issues.
  • Developed and implemented data governance policies and procedures.

Project Manager Investigator Sponsored Studies

AstraZeneca
06.2003 - 04.2011
  • Responsible for managing large Product Programs of Investigator Sponsored Studies, including Local and Global programs
  • Managed multi-million dollar budgets for these programs, along with project plans and cross-functional teams
  • Reviewed and approved all submissions, as well as contracts and publications
  • Responsible for all communications regarding program to internal and external stakeholders
  • Developed metrics to provide to leadership to ensure policy compliance in response to CIA
  • Process Lead on large scale global process and system development for IIS Management Analyzed global processes to harmonize and standardize practices across regions and functional areas
  • Developed SOPs, Working Instructions, and training to implement these processes
  • Collaborated with Governance Committee post implementation and led change management team
  • Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
  • Established effective communication among team members for enhanced collaboration and successful project completion.
  • Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
  • Delivered exceptional customer satisfaction by proactively addressing client concerns and meeting or exceeding expectations throughout the engagement process.
  • Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
  • Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
  • Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
  • Coordinated with cross-functional teams to resolve project issues and mitigate risks.
  • Provided detailed project status updates to stakeholders and executive management.
  • Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
  • Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
  • Negotiated and managed third-party contracts related to project deliverables.
  • Negotiated contracts with vendors and suppliers, securing quality materials at competitive prices for efficient use of resources.
  • Created accurate budgets based on resource requirements, allowing for optimal allocation of funds across all aspects of the projects.
  • Effectively managed scope creep by establishing clear boundaries on requested changes while keeping projects aligned with original objectives and budgets.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Maintained compliance with industry standards and regulations, conducting regular audits and updates to project practices.
  • Developed comprehensive risk management plans, minimizing project delays and unexpected challenges.
  • Improved stakeholder satisfaction with detailed project updates and proactive issue resolution.
  • Completed projects within tight deadlines, coordinating team efforts and prioritizing tasks effectively.
  • Improved client relationships, consistently meeting or exceeding project expectations and maintaining open lines of communication.
  • Led cross-functional teams to successful project completions, improving team cohesion and productivity with effective leadership strategies.
  • Enhanced project visibility, implementing dashboard and reporting tools for real-time progress monitoring.
  • Promoted innovation within project teams, encouraging exploration of new tools and methodologies to enhance project outcomes.
  • Oversaw implementation of new project management software, facilitating more efficient workflow and better project tracking.
  • Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
  • Reported regularly to managers on project budget, progress, and technical problems.
  • Developed and implemented project plans and budgets to ensure successful execution.
  • Facilitated workshops to collect project requirements and user feedback.
  • Managed and supervised administrative and daily program operations, complying with policies and regulations.
  • Established strong relationships with key stakeholders, ensuring support for program initiatives.
  • Developed strategic plans, setting clear objectives and achievable milestones for the team.
  • Managed cross-functional teams for successful project completion within deadlines and budgets.
  • Facilitated workshops and conducted one-on-one training to educate team members.
  • Managed multiple strategic projects with numerous sub-projects or workstreams.
  • Identified program obstacles and communicated possible impacts to team.
  • Met with project stakeholders on regular basis to assess progress and make adjustments.
  • Ensured regulatory compliance by closely monitoring adherence to industry standards and guidelines throughout the program lifecycle.
  • Addressed and resolved technical, financial, and operational concerns by working with team members and directors.
  • Optimized resource allocation, effectively balancing priorities and managing competing demands.
  • Built teams to address project goals and objectives for multiple projects.
  • Improved program efficiency by streamlining processes and implementing time-saving solutions.
  • Enhanced project visibility with regular status updates, leading to increased stakeholder engagement.
  • Collaborated with business leadership to set priorities based on business needs, resource capacity and risk exposure.
  • Worked with subject matter experts to develop and implement mentoring programs to promote better learner experiences.
  • Engaged and worked alongside cross-functional stakeholders to manage strategic initiatives.
  • Increased customer satisfaction through effective communication of program goals and expectations.
  • Leveraged technology tools for enhanced project tracking, reporting, and information sharing among team members.
  • Leveraged project management processes and tools to define and execute projects.
  • Implemented risk management strategies to mitigate potential barriers to project success.
  • Led change management efforts, supporting staff through transitions and promoting buy-in for new initiatives.
  • Negotiated contracts with vendors, securing favorable terms that supported budgetary constraints.
  • Interacted with customers and clients to identify business needs and requirements.
  • Established team priorities, maintained schedules and monitored performance.
  • Established performance goals for employees and provided feedback on methods for reaching those milestones.
  • Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
  • Successfully managed budgets and allocated resources to maximize productivity and profitability.
  • Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
  • Used industry expertise, customer service skills and analytical nature to resolve customer concerns and promote loyalty.
  • Maintained professional demeanor by staying calm when addressing unhappy or angry customers.
  • Planned, created, tested and deployed system life cycle methodology to produce high quality systems to meet and exceed customer expectations.

Education

Bachelor - Psychology, Sociology

Arcadia university
05.1991

Skills

  • Leadership
  • Project Management
  • Process Analysis
  • Training
  • Communication
  • Vendor Management
  • System Implementation
  • Regulatory Compliance
  • Document Management
  • SDLC
  • Agile
  • Waterfall
  • Change Management
  • Business process improvement
  • User acceptance testing
  • Software development life cycle
  • Troubleshooting
  • Requirements analysis
  • Software testing
  • Project management
  • Business analysis
  • Requirements gathering
  • Software development
  • Business collaboration
  • Teamwork and collaboration
  • Problem-solving
  • Problem-solving abilities
  • Multitasking
  • Excellent communication
  • Effective communication
  • Adaptability and flexibility
  • Relationship building
  • Task prioritization
  • Analytical thinking
  • Adaptability
  • Information systems
  • Systems analysis
  • Database administration
  • Change management

Timeline

IM Lead - Clinical, Safety, Regulatory

Adaptimmune
11.2021 - Current

Clinical Vendor Management Analyst

ICON (PRA Health Sciences)
06.2020 - 11.2021

Senior Business Analyst

IQVIA
07.2019 - 11.2019

System Analyst

PRA Health Sciences
02.2018 - 07.2019

Clinical Business Process Analyst

Shire/Kelly Services
09.2013 - 12.2013

Product Manager

ePharmaSolutions
02.2013 - 09.2014

Project Manager Investigator Sponsored Studies

AstraZeneca
06.2003 - 04.2011

Bachelor - Psychology, Sociology

Arcadia university

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