LYNDAH MAXWELL
Waltham
Summary
Accomplished clinical operations leader with extensive experience in developing operational strategies that enhance study efficiency and compliance. Skilled in managing cross-functional teams to meet strategic enrollment targets while ensuring adherence to GCP and regulatory standards.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Global Clinical Operations Lead & Patient Engagement - Contract
Grunenthal USA
Waltham
03.2024 - Current
- Led development of clinical operations team USA, establishing guidelines for drug development operations at Grunenthal USA.
- Ensured that all clinical trials within the program were sourced on time, CRO bid, and selection executed effectively, study timeline goals achieved and budget apportioned realistically, all in compliance with GCP and other applicable regulations.
- Implement operational solutions to accelerate recruitment and maintain patient retention.
- Developed operational plans, initiatives and programs that support the implementation of the Clinical trials and patient experience strategy at the organizational and department level.
- Streamlined business processes for study, country, and site feasibility, scenario modeling, and enrollment projections while creating an Operational Design Centre for study design and feasibility.
- Identify operational risks and establish proactive mitigation strategies to maintain study quality and timelines.
- Led co-design efforts to deliver insights by facilitating focus group sessions and conducting interviews with patients and healthcare providers.
- Experienced in building and scaling a patient call center including software vendor selection and developing necessary SOPs, SLAs, and KPIs to ensure patients and providers have a best-in-class experience per industry standards for connecting to care.
Director - Study Start-Up Operations
Alkermes / Mural Oncology
Remote
11.2022 - 03.2024
- Lead and manage the efforts of all key functional departments to perform all project-related activities according to project milestones/timelines, and quality standards in a manner consistent with study processes.
- Overall management of CRO deliverables on assigned therapeutic area programs and ensuring enrollment projections are met successfully.
- Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
- Trained, managed performance, and developed clinical staff, CRAs, and CTAs.
- Identified quality issues within study through regular review of site communications, monitoring visit reports, data flow information, and quality assurance audit findings; implemented corrective action plans.
- Vendor Management inclusive of selection, negotiation, implementation and management of vendor Scope of Work and budget.
- Collaborated with functional groups to support milestone achievements and address study issues and obstacles.
- Execute effective submissions and Investigator contract negotiation amongst sites.
- Identify industry innovation opportunities in recruitment and bring best practice solutions to the team.
Senior Clinical Scientist
MERCK
Morristown
10.2020 - 01.2022
- Led collaboration with new business partners on approved prescription medicine KEYTRUDA (pembrolizumab) to advance immunotherapy initiatives.
- Developed risk mitigation strategies and action plans, resolving issues for cross-functional project management.
- Monitor and manage study progress and obstacles to mitigate risks to deliverables.
- Developed and implemented enrollment strategies with CRO, addressing foreseen risks and communicating updates to key stakeholders.
- Ensure accurate tracking of any relevant study information and assist the PM/CTM in implementing quality standards and ensuring compliance with study metrics requirements as set by the contract.
- Maintain high-level and detailed timelines across functional groups to ensure deliverables are met in accordance with anticipated regulatory submissions.
- Communicated site risk level changes to local teams and implemented them in EDC.
- Assisted in the development and design of clinical protocols, CRF, study tools, and other documents.
Study Start-up and Feasibility Manager
CSL Behring LLC
King of Prussia
09.2015 - 03.2018
- Leading feasibility team, providing oversight and guidance to ensure consistent delivery of quality service.
- Initiate Feasibility strategy, develop new process of Feasibility for global standard operating procedures. Develop, implement and manage standards and processes for initiating study start-Up activities.
- Created feasibility strategies with study optimizer and TA-SCAN tools to identify efficient countries for study enrollment and outlined strategic plans for new study implementation.
- Developed and maintained enrollment projections for ongoing studies using study optimizer, ensuring optimal scenarios selected by the study team were approved and documented for tracking.
- Ensured that study teams receive timely enrollment status reports, including monthly up to date projections of enrollment completion based on actual performance.
- Perform assessment of clinical protocols to assess the challenges of patient recruitment.
- Developed patient recruitment programs for multiple therapeutic areas.
- Execution of successful project initiatives to enhance current work practices and optimization of core tasks.
- Serve as the operational lead in the day-to-day management of complex, rare disease studies or multi-study programs, supporting design, overseeing implementation, and delivery and reporting of these projects or programs.
- Lead facilitator of vendor projects from bid defenses to project awarding.
- Conduct UAT for upgrade of all study systems. Oversight of all monitoring of activities.
- Manage direct reports personnel and submit end of year evaluations on each individual.
SNR. Clinical Trial Manager
Incyte Corporation
Wilmington
01.2014 - 04.2015
- Development and oversight of study rescue project and implementing measures to ensure improvement on enrollment recruitment.
- Develop operational strategies including scenario planning (country/site optimization) monitoring strategy and implementation to ensure smooth running of study activities.
- Manages recruitment at country/site level in order to achieve clinical research targets.
- Develop and deliver feasibility capability and provide expertise in the recruitment and selection of qualified investigators in support of clinical projects by data mining internal data assets and using external data if appropriate.
- Perform feasibility assessment of clinical protocols to assess the operational impact by the protocol design, interpretation of past performance data and its relevance to current protocol.
- Coordinated cross-functional project teams to achieve milestones and resolve study issues.
- Develop study management plans and periodically update for consistency.
- Oversees budgets and contracts to ensure trial execution is within approved country budget.
- Contributed to recruitment strategy and developed contingency plans with other functions.
- Recommended and implemented contingency plans based on project assessments.
Senior Clinical Study Manager
Grunenthal Pharmaceuticals
Bedminster
01.2009 - 09.2010
Clinical Project Manager
Morphotek
Exton
01.2008 - 01.2009
CRA III/Senior Lead
Health Research NIHR
King of Prussia
01.2004 - 01.2008
Education
Bachelor of Law -
University of Lagos
07-2003
Skills
- Clinical Trial Design
- Patient Engagement Strategies
- Clinical Data Review
- Inspection Readiness
- Quality Assurance
- Data Quality
- Risk Assessment
- Mitigation Strategy
- SOP writing
- SOP development
- Vendor Management
- Contract Negotiation
- Budget Management
- Business Development Strategy
- Safety review
Certification
Introduction to Good Clinical Practice, RPS, Research Pharmaceuticals Services, Inc, Fort Washington, PA
Languages
English, Expert
Passions
Involved in Community Based Screening - Raising awareness and offering access to care for individuals who may typically be missed by the healthcare system.
Timeline
Global Clinical Operations Lead & Patient Engagement - Contract
Grunenthal USA
03.2024 - Current
Director - Study Start-Up Operations
Alkermes / Mural Oncology
11.2022 - 03.2024
Senior Clinical Scientist
MERCK
10.2020 - 01.2022
Study Start-up and Feasibility Manager
CSL Behring LLC
09.2015 - 03.2018
SNR. Clinical Trial Manager
Incyte Corporation
01.2014 - 04.2015
Senior Clinical Study Manager
Grunenthal Pharmaceuticals
01.2009 - 09.2010
Clinical Project Manager
Morphotek
01.2008 - 01.2009
CRA III/Senior Lead
Health Research NIHR
01.2004 - 01.2008
Bachelor of Law -
University of Lagos