Lisa Haynes Email & Phone Number

Durham, North Carolina, US

• Provide an extensive range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and clients
• Participate in cross functional meetings and support initiatives to ensure the delivery of milestones and timelines for clinical trials
• Responsible for the creation and execution of a project timelines plan covering all GDO deliverables; this includes the coordination of dependencies between Data Operation stakeholders (Data Management, Programming.
• Provide input to proposals and attend Bid Pursuit meetings as required
• Participate in end of study meetings and collate lessons learned information and feedback relevant information into the functions
• Identify and request staff necessary for the project team

Durham, North Carolina, US

• Provided leadership to ensure the project or program is completed within budget, schedule and according to contract specifications. Ensure the project/program is progressing according to quality standards, SOPs, ICH.
• Thorough knowledge of numerous EDC systems and additional tools and systems that can be integrated with a particular EDC system.
• Thorough knowledge of all activities for Database Set-up, Study Maintenance and Database lock. Review of metrics to determine risks and risk mitigation plans as required.
• Effectively communicated and managed internal project teams, external customers and third party vendors. Held team meetings on a regular basis. Participated in client, investigator and team meetings.
• Effectively managed contracted project delivery. Highlighted issues/risks to delivery and mitigated risks for both PAREXEL and the client, developing contingency plans for the project (or providing input to PL)..
• Managed appropriate project level resourcing of staff and staff assignments. Identified and requested staff necessary for the project team.

Durham, North Carolina, US

• Provided Data Operations Oversight for all Global Data Operations tasks assigned for PAREXEL.
• Overall leadership/management for programming, data integration, data processing and statistical services on a project.
• Responsible for coordination of the Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders and the clients as a single point of contact to.

Dublin, Coolock, IE

• Provided specialized knowledge and detailed attention to lead and carry out data management activities in support of multiple clinical trials
• Defined project timelines and executed the clinical data management operations against them, and any other priorities
• Worked within clinical study teams as an extended team member
• Used defined department metrics as a framework for timely and quality clinical data management deliverables
• Collaborated with peers within and outside the Global Development Operations organization to pro-actively manage data availability and integration
• Responsible for the role which included executing the design, documentation, testing, and implementation of data collection systems and processes in support of the clinical study teams in accordance with existing.

South San Francisco, California, US

• Managed data management activities performed at CRO and vendors across multiple studies to ensure delivery against contracted scope of work within budget & against timelines
• Provided input/feedback to management regarding budgets, staffing, procurement, bid defense meetings, forecasting, standards, process improvements, etc.
• Drove data activities from start-up to database close-out, providing project management of data management activities and overseeing project milestones/tasks
• Integral member of study management teams (SMT) leading or providing input into the development of the CRF/eCRF and validation checks, eCRF guidelines, Investigator Meeting presentations, coordinator trainings, DMP.
• Reviewed data for quality oversight and provided feedback to CROs/SMTs
• Communicated study status of data flow and quality throughout the lifecycle of the clinical trial/disease registry and advised on specific data inquiries, trends, issues

Switzerland 🇨🇭, CH

• Responsible for the leadership, planning and delivery of all data management activities (from start-up to closure) within one or more study(ies), to ensure the effective and efficient delivery of quality data for.
• Contributed to data management resources planning, timelines, risk management and quality plans at study level
• Ensured use of global and project standards across documents and across studies
• Managed data management activities performed at CRO and vendors to ensure delivery against contracted scope of work. Included training on study specific modules.
• Local Inspection Readiness Representative ensuring ICH GCP regulations and SOPs were adhered to within the data management team
• Managed assigned resources and mentored fellow team members

Basel, Baselstadt, CH

• Served as Project Data Manager for global CNS trials
• Responsible for ensuring consistency of protocols, Validation and Analysis plans, and project CRFs for all trials within assigned projects
• Tracked and reported status and progress of data management for allocated trials
• Proactively ensured the smooth and successful locking of databases for interim soft locks, DSMBs, and final hard locks
• Identified errors and inconsistencies in both paper CRF data and EDC data and ensured their resolution
• Performed SAE and external data resolution in order that databases could be declared clean

Bedminster, NJ, US

• Successful participation in FDA audit
• Managed/coordinated clinical data management project teams, activities, resources and budgets
• Managed study start-up activities including: Case Report Form design, preparation of CRF completion guidelines, data entry instructions and data handling conventions, Data Management Plan development, UAT and site.
• Performed data review/cleaning activities as required during study conduct including lab data reconciliation and SAE reconciliation. Active member of Study Management Team
• Coded adverse events using MedDRA and medications using WHO DRUG
• Coordinated/managed data closure activities including evaluability meetings, Quality Control and Quality Assurance functions