Jennifer Aulsebrook
Maryville,USA
Summary
Dedicated and dynamic leader in the clinical research industry with diverse experience in managing technical programs and leading cross-functional teams. Proven track record of successful project execution and process optimization. Demonstrated ability in strategic planning and risk management.
Technical professional equipped with diverse experience in managing complex technical projects. Consistently drives project success through strategic planning and effective problem-solving. Known for fostering team collaboration and adaptability to dynamic environments. Expertise in stakeholder communication and program lifecycle management.
Overview
28
28
years of professional experience
Work History
Technical Program Manager (Client Delivery & Engagement Manager)
Medidata AI, a Dassault Systèmes company
04.2021 - Current
- Manage initiatives for existing applications/processes, as well as, exploring new applications/processes for the Clinical Data and Regulatory Innovations department (e.g., Box, Kantata, Amazon Workspace for clients, SAS server, FDA’s Electronic Submissions Gateway (ESG) to improve quality, reduce costs, increase productivity and improve cycle time by reducing wasted time, rework, etc. resulting in business improvement and customer satisfaction
- Lead qualification, selection and oversight of vendors and contractors to grow Medidata AI technical operations and achieve our business goals, foster vendor and supplier relationships including leading regular meetings to discuss scope and activities, manage contracts, onboarding/offboarding to mitigate risk and ensure successful performance
- Engage and lead team members in managing comprehensive contractor and new hire onboarding, maintenance and offboarding processes
- Provide technical support and develop technical efficiencies to assist users in their daily functions. Superuser for functionality of RCM and Salesforce.
- Spearhead Quality System Document process development for Synthetic Control Arm (SCA) managed service delivery. This includes oversight for the development of SOPs, Work Instructions, Templates, Forms, Software Qualification, Training and Process documents.
- Provide operational support for Quality System Document management, Quality Incident (QI) management, Exception/Pilot program, Technical Qualification/Validation program
- Use wide range of experience to ensure audit/inspection-readiness and conduct activities related to regulatory inspections and internal or client audits
- Support management of Integrated Evidence (CSA/Data) projects involving large amounts of data, statistical modeling/machine learning, product design and development of cloud-based software products.
- Work across an interdisciplinary team to prioritize and coordinate tasks, monitor progress and issues, facilitate team and customer-facing meetings.
- Participate in and support interactions with clients to collect business requirements and drive project, delivery and client satisfaction.
- Develop external communication materials, translating and summarizing technical information for business audiences and developing key messaging.
- Managed vendor relationships to ensure timely deliveries and adherence to contract terms for optimal results.
- Delivered high-impact presentations to stakeholders demonstrating program value, progress updates, and strategic recommendations.
- Developed comprehensive training materials to support onboarding new team members quickly and effectively.
- Successfully managed multiple simultaneous projects while adhering to strict deadlines for optimal progress tracking.
- Collaborated with team to define and explore business challenges, creating technical roadmaps based on findings.
- Championed process improvements, introducing streamlined workflows that increased productivity across teams.
- Fostered a culture of continuous learning by providing ongoing mentorship opportunities for team members seeking professional growth.
- Managed implementation of new technological improvements resulting in increased efficiency.
- Managed complex engagements involving multiple teams and large budgets, consistently meeting or exceeding expectations.
- Managed client expectations and mitigated potential conflicts, ensuring a high level of customer satisfaction throughout the engagement process.
- Delivered impactful presentations showcasing project results, earning recognition from senior management for excellent communication skills.
- Developed comprehensive project plans outlining key milestones, resource requirements, and deliverables to provide clients with a clear roadmap for success.
Senior Engagement Consultant
Medidata Solutions, a Dassault Systèmes company
02.2019 - 04.2021
- Responsible for the implementation of Medidata’s Design Optimizer (DO) and Centralized Statistical Analytics (CSA)/Detect Solutions, including enabling clients on the analyses for the applications.
- Lead the efforts for Study Design Optimization (SDO) and Trial Assurance (TA) Managed Service, including comprehensive data analyses. This includes, but is not limited to, data analytics review to identify anomalies within the clinical trial data, provide guidance on optimizing the technical configuration of the advanced analytics applications, conduct risk assessment for Key Risk Indicators (KRIs), aptitude for understanding the statistical background and the machine-learning and algorithms to provide client support, develop and deliver analysis results and comprehensive insights to customers.
- Subject Matter Expert for two Medidata Platform Products (Design Optimizer and Centralized Statistical Analytics/Detect) which involves collaboration with the Product Adoption Optimization, Research/Development, Sales/Marketing teams. Ensures updates/enhancements to collateral are accurate and rolled out to teams, as appropriate. Develops comprehensive training and demonstrations for internal and client-facing contacts.
- Act as Coding Specialist for the Data Management/Data Operations team, as well as, enabling clients on coding into Medidata’s Design Optimizer solution.
- Session Chair for the Society for Clinical Data Management (SCDM) Annual Conference, leading the following panel discussion: “Cut Through the Data Clutter: Mitigate Risk Before it Becomes an Issue”, which discussed the exponential growth in clinical research data from disparate sources, data quality issues that persist, and how utilizing Machine Learning/Artificial Intelligence (AI) detects anomalies/patterns/trends in the data to help mitigate risk.
- Engagement Consultant responsibilities as defined below.
Engagement Consultant
Medidata Solutions
05.2017 - 02.2019
- Collaborate with clients to ensure a smooth implementation with Medidata Platform Solutions and services for clinical trials.
- Act as program/project managers for any scale of implementation taking a key role in delivering effective services to ensure our clients succeed.
- Responsible for client satisfaction and delivery metrics (on-time/on-budget) for all assigned clients.
- Focus on delivery of consulting services, including but not limited to: conducting client interviews to understand complex business issues, develop client presentations, and developing conclusions/recommendations for customers (always working to drive immediate and long-term value).
- Completing and managing client work in accordance with established budgets, work plans, quality standards, and timeframes.
- Ability to define and scope new consulting services revenue opportunities and seeing these opportunities through to successful conclusion.
- Drive consulting services revenue from analysis phase through to completion of engagement.
- Manage and operate consultative offerings around all Medidata Platform Solutions and services.
- Drive high level of billable, utilization and profitability for services rendered under their remit.
- Nurture assigned client accounts and develop sponsor relationships to increase Medidata consulting and product footprint.
- Recognized expert/trusted advisor/consultant in Medidata Platform Solutions and services.
- Maintain high levels of client satisfaction through delivery.
- Maintain reference able clients from beginning to end of the project/engagement life cycle.
- Participate in direct sales cycle support as necessary.
Sr. Project Quality Lead/Account Quality Lead
PAREXEL International
09.2013 - 04.2017
- Holistic approach to Quality in Clinical Research by collaborating in all cross-functional areas (Clinical, Project Management, Data Management, Pharmacovigilance, Supplies) to proactively prevent issues and to effectively mitigate risk.
- Quality expert and oversight with clinical trials experience providing high-level quality leadership across the account.
- Support oversight of quality on the account through collaboration with the Sponsor, Project Director, Study Team, Key Opinion Leaders, and Sites.
- Provides guidance for remediation of account level quality risks, quality issues and CAPAs.
- Attends executive steering committee meetings to discuss account quality related topics.
- Facilitates the collation and reporting of account quality metrics. Reviews the metrics results and provides interpretation.
- Primary quality contact with the sponsor for account level concerns.
- Perform, report, and coordinate the quality evaluations for assigned projects, verifying compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements.
- Actively participate in key internal project team meetings and facilitate quality discussions during these meetings.
- Schedule and lead the project related Quality Forums.
- Attend client meetings with project team leadership to collaborate with and participate in discussions related to quality.
- Provide quality advice to the project teams.
- Provide support with investigation of Quality Issues and support of QI management including classification of issues, consultation on appropriateness of corrective and preventive actions.
- Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on project related audit/inspection responses generated by project team members per applicable SOPs.
- Evaluate the quality status of a project by reviewing applicable project quality metrics.
- Identify and evaluate potential risks and quality issues in collaboration with project team leadership and other relevant parties (e.g. operational and functional staff). Together with these parties, determine appropriate mitigation measures.
- Mentor Project Quality Leads I and II.
- Identify process improvement opportunities and communicate to process owners.
- Participate in SOP and process development.
Associate Clinical Operations Leader (Clinical Team Lead)
PAREXEL International
05.2012 - 09.2013
- Provide quality consultation and support to the study team including but not limited to overseeing assigned CAPAs, recommending and implementing preventative and corrective action plans for study improvement, root cause analysis, preparing and responding to client and internal audits, and verifying study compliance with ICH-GCP and FDA guidelines.
- Support Project Leader with coordination of the clinical team including evaluation and identification of resourcing needs, provision of performance feedback, organization and participation in client, investigator and team meetings, direction to the clinical team, identification and facilitation of study training needs. This included management of 10-20 CRAs.
- Responsible for report review, ongoing assessment of monitoring study timelines and patient recruitment, maintaining and assuring quality of work generated, identifying changes in scope and liaising with Project Leader, including early recognition of potential problems and contingency planning.
- Ensure client deliverables and study metrics are completed on time with a high level of quality.
- Performed additional Clinical Operations Leader duties as outlined by company policy including but not limited to, risk-based/central monitoring activities, resourcing, vendor management, document management, Audit/Inspection activities, managing CRA/CMA activities, preparation and presentation of key study metrics/milestones, facilitate key Sponsor meetings, and study training.
- Mentor for onboarding Clinical Operations Leaders.
Certified Senior CRA/Acting Associate Project Manager
Quintiles Transnational (IQVIA)
11.2010 - 05.2012
- Acting Associate Project Manager - Provided sponsor data manipulation and analysis of study metrics, comprehensive education program development and execution of training for CRAs/PMs, technical and on-site support for over 80 CRAs, and strategic CRA/site conflict resolution.
- Strategically reorganized sites which required detailed escalation plans to bring them to compliance while maintaining superior customer satisfaction and partnership.
- Retention-focused and driven to incorporate appropriate site training in order to maintain excellent and successful study retention.
- Maintained technical systems support with site staff in order to provide training and target deficiencies that were corrected for the team to improve efficiency.
- Milestones and deliverables exceeded the expectations of required timelines with excellence in quality.
- Performed Clinical Research Associate and Site Manager duties as outlined by company policy.
Certified Clinical Research Associate I & II
PAREXEL International
08.2008 - 11.2010
- Back-up Clinical Operations Leader - Provided support for the CRA team which included but was not limited to training, vendor communication, conflict resolution, and Sponsor communication.
- Trained and mentored fellow Clinical Research Associates to assist in all aspects of their job functions.
- Targeted and organized several “clean-up” sites including regulating timelines to ensure the site moves to compliance with exceptional adherence to all appropriate guidelines.
- Super-user and trainer for IMPACT Harmony. Liaised with the IT team to determine the necessary upgrades for continuous system improvements.
- Performed Clinical Research Associate and Site Manager duties as outlined by company policy.
Experience as Laboratory Supervisor, Medical Technologist, Point of Care Coordinator, Business Operations Specialist
CU Health Sciences Center
08.1997 - 08.2008
Education
Bachelor of Sciences - Medical Technology
CU Health Sciences Center
Denver, CO08.1997
Biology, Chemistry
Metropolitan State University of Denver
Denver, CO08.1996
Skills
- 25 years Clinical, Data and Analytics, Project Management
- Phase I, IIA, IIB, IIIB, IV (Late Phase)
- Extensive Therapeutic and Clinical Experience, including 20 years in Oncology
- Drug, Device, Biologic, Global Studies
- Process Improvement and Change Management
- Quality System Document and SOP Development
- Vendor Procurement and Management
- Contract and Supplier Negotiations
- Audit/Inspection Preparation, Conduct, Follow-Up
- Regulatory Compliance
- ICH-GCP Guidelines
- FDA, Regulatory Authorities
- IRB/EC Guidelines
- CAPA and Risk Assessment
- Machine Learning / Artificial Intelligence (AI)
- Data Management and Pharmacovigilance Support
- Education Developer and Trainer
- Mentor and Technical Systems Support
- Field Experience (IM, QV, IV, MV, TV, Quality Visits)
- EDC/eCRF, ePRO, IVRS/IWRS, CTMS
- Study Start-up and Site Management
- Risk-Based Central Monitoring
- Services, Productivity, and Customer Satisfaction
- Organization and Efficiency Expert
- Communication, Motivation, and Interpersonal Skills
- Strategic Conflict Resolution and Escalation
- Milestones and Deliverables Exceed Expectations
- Field Experience (IM, QV, IV, MV, TV, Quality Visits)
- EDC/eCRF, ePRO, IVRS/IWRS, CTMS
- Study Start-up and Site Management
- Risk-Based Central Monitoring
- Services, Productivity, and Customer Satisfaction
- Organization and Efficiency Expert
- Communication, Motivation, and Interpersonal Skills
- Strategic Conflict Resolution and Escalation
- Milestones and Deliverables Exceed Expectations
- Field Experience (IM, QV, IV, MV, TV, Quality Visits)
- EDC/eCRF, ePRO, IVRS/IWRS, CTMS
- Study Start-up and Site Management
- Risk-Based Central Monitoring
- Services, Productivity, and Customer Satisfaction
- Organization and Efficiency Expert
- Communication, Motivation, and Interpersonal Skills
- Strategic Conflict Resolution and Escalation
- Milestones and Deliverables Exceed Expectations
Timeline
Technical Program Manager (Client Delivery & Engagement Manager)
Medidata AI, a Dassault Systèmes company
04.2021 - Current
Senior Engagement Consultant
Medidata Solutions, a Dassault Systèmes company
02.2019 - 04.2021
Engagement Consultant
Medidata Solutions
05.2017 - 02.2019
Sr. Project Quality Lead/Account Quality Lead
PAREXEL International
09.2013 - 04.2017
Associate Clinical Operations Leader (Clinical Team Lead)
PAREXEL International
05.2012 - 09.2013
Certified Senior CRA/Acting Associate Project Manager
Quintiles Transnational (IQVIA)
11.2010 - 05.2012
Certified Clinical Research Associate I & II
PAREXEL International
08.2008 - 11.2010
Experience as Laboratory Supervisor, Medical Technologist, Point of Care Coordinator, Business Operations Specialist
CU Health Sciences Center
08.1997 - 08.2008
Bachelor of Sciences - Medical Technology
CU Health Sciences Center
Biology, Chemistry
Metropolitan State University of Denver
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