Mara Kramer
Flemington,NJ
Summary
Clinical Research Professional with expertise in Regulatory Affairs and Clinical Site Management. Demonstrated success in managing clinical trials across Metabolism, Cardiovascular, and Oncology sectors. Strong understanding of GCP, SOP, and regulatory requirements for phases I-IV. Skilled in leveraging technology and data analytics to improve processes and enhance organizational efficiency.
Overview
23
23
years of professional experience
Work History
Feasibility Transversal Projects Lead
Sanofi USA
Morristown, New Jersey
05.2023 - Current
- Executed Go Early feasibility process delivery, integrating AI analytic systems and strategy consolidation.
- Led implementation of Feasibility and Enrollment Modeling Platform, collaborating with ZS Associates.
- Directed features for AILY PLAI study forecaster and site performance, delivering MVP2.
- Managed development of Power BI outreach dashboard, achieving successful status delivery.
- Oversaw global profiling for Site Intelligence, engaging with Digital, BICC, and external stakeholders.
- Coordinated country journey mapping dashboards, enhancing strategic planning capabilities.
- Designed and implemented standardized processes in Early Operational Strategy to optimize data-driven approaches.
- Facilitated change management initiatives to ensure smooth adoption of feasibility processes.
Deputy Head of Feasibility and Competitive Intelligence
Sanofi USA
01.2022 - 04.2023
- Developed communication strategy and roadmap for feasibility and competitive intelligence to enhance trust in digital solutions for clinical trials.
- Managed global feasibility managers, assessing workload and distributing studies among GFLs based on objectives.
- Led feasibility platform implementation for ACT4Patients EBD Project as of February 2023.
- Facilitated effective communication and strategy identification within CI&F team aligned with Play to Win behaviors.
- Coordinated meetings and communication strategies with Head CI&F to enhance collaboration.
- Analyzed Sanofi's portfolio and planned studies to ensure timely data availability and resource allocation.
- Oversaw management of 11 global feasibility leads, monitoring workload and activity distribution along with CDS integration.
- Conducted area workload analysis and prospective FTE planning, including data opportunity discussions with GFL and CDS.
Global Feasibility Lead
Sanofi USA
Flemington, New Jersey
04.2018 - 01.2022
- Influenced protocol design by conducting data-driven feasibility studies to identify clinical trial opportunities and risks.
- Contributed innovative ideas and solutions to enhance team performance and outcomes.
- Reduced protocol amendments and alleviated burdens on patient participants and investigational centers through strategic planning.
- Facilitated operational communication for Phase I-IV Sanofi and GZ portfolios across the operational platform.
- Identified internal competition risks and proposed mitigation strategies to enhance program support.
- Coordinated global roll-out of operational protocol feasibility activities with Business Units and stakeholders.
- Developed scenarios for global study conduct, addressing protocol design risks and regulatory implications.
- Conducted competitive intelligence analysis to inform planning from initial protocol stages to country selection.
- Participated in process analysis groups to identify opportunities for improvement.
Global Feasibility Lead
Pro Unlimited @Sanofi USA
Las Vegas, Nevada
01.2017 - 04.2018
- Influenced protocol design by identifying clinical trial opportunities and risks through data-driven feasibility studies.
- Reduced protocol amendments, alleviating burden on clinical trial participants and investigational centers.
- Led operational communication for Phase I-IV Sanofi and GZ portfolio across the operational platform.
- Identified internal competition risks and proposed strategies for effective risk mitigation.
- Coordinated global rollout of operational protocol feasibility activities among Business Units and stakeholders.
- Developed comprehensive scenarios for study conduct, addressing regulatory implications and competitive factors.
- Evaluated clinical protocols considering medical standards and program-specific mitigating factors.
Clinical Trials Coordinator
PRA USA
Las Vegas, Nevada
03.2015 - 12.2016
- Contributed to startup processes to ensure effective project initiation.
- Executed quality assurance for documents, ensuring compliance with regulatory site requirements.
Regulatory Affairs Manager, Clinical Study Unit
Sanofi, Mexico
Mexico MX, Mexico DF
03.2013 - 08.2014
- Managed regulatory area of Clinical Study Unit, overseeing five direct reports serving over 70 internal contributors.
- Achieved efficiency improvements by reducing timelines and promoting team development initiatives.
- Prepared, generated, and implemented local SOPs, guidelines, and templates, standardizing project management across functions.
- Conducted quality assurance reviews of regulatory packages including protocols, amendments, and investigator brochures.
- Monitored regulatory applications to ensure compliance with Ministry of Health statuses.
- Represented CSU as regulatory expert, advising on risks and strategies for implementation with various stakeholders.
- Facilitated communication between countries regarding regulatory requirements across multiple Latin American platforms.
- Collaborated with corporate teams in France to align on regulatory matters and compliance specifications.
Bachelor of Nutrition Professor
Intercontinental University (UIC) Mexico
Mexico MX , Mexico DF
01.2012 - 03.2013
- Led multiple courses including Diet Therapy, Nutrition Condition Assessment, and Diet Therapeutic Calculation.
- Mentored students in Clinical Investigation Methodology to enhance research skills.
- Oversaw laboratory sessions to ensure practical application of theoretical knowledge.
- Developed course materials to align with current dietary guidelines and practices.
Clinical Site Manager, Clinical Trials Area
Bristol Myers Squibb, Mexico
Mexico MX, Mexico City
04.2007 - 11.2011
- Served as Site Manager, overseeing process from startup to database closure.
- Supervised daily site operations to ensure compliance with safety regulations.
- Achieved recruitment goals through effective action plans and monitoring.
- Supported principal investigators to enhance study execution.
- Conducted feasibility studies, site selection, and controlled translation processes.
- Managed IRB and MOH submissions, ensuring compliance with local regulations.
- Updated drug labels according to country-specific requirements.
- Maintained accurate regulatory trackers for over 350 sites, including CROs.
- Coordinated regulatory processes across LATAM regions, including Mexico and Panama.
Investigation Assistant and Study Coordinator
Medical Sciences and Nutrition National Institute (INCMNSZ) Mexico
Mexico MX, Mexico City
09.2002 - 03.2007
- Facilitate and organize Medical Direction activities related to internal and pharmaceutical investigations.
- Coordinated project activities across medical nutrition research teams.
- Assisted in preparing research materials for clinical trials and studies.
Education
Certificate - Course of Drug Development Process and Regulatory Impact
The Greenberg Center
06.2011
Bachelor of Science - Nutrition
Universidad Veracruzana
Veracruz, Mexico01.2002
Skills
- English and Spanish fluency
- AI analytics expertise
- Feasibility studies
- Project coordination
- Data visualization techniques
- Competitive market analysis
- Clinical trial administration
- Proficient in Microsoft Office Suite
- Skilled in Adobe Creative Suite
- Strategic planning and adaptability
- Effective problem solving and multitasking
Timeline
Feasibility Transversal Projects Lead
Sanofi USA
05.2023 - Current
Deputy Head of Feasibility and Competitive Intelligence
Sanofi USA
01.2022 - 04.2023
Global Feasibility Lead
Sanofi USA
04.2018 - 01.2022
Global Feasibility Lead
Pro Unlimited @Sanofi USA
01.2017 - 04.2018
Clinical Trials Coordinator
PRA USA
03.2015 - 12.2016
Regulatory Affairs Manager, Clinical Study Unit
Sanofi, Mexico
03.2013 - 08.2014
Bachelor of Nutrition Professor
Intercontinental University (UIC) Mexico
01.2012 - 03.2013
Clinical Site Manager, Clinical Trials Area
Bristol Myers Squibb, Mexico
04.2007 - 11.2011
Investigation Assistant and Study Coordinator
Medical Sciences and Nutrition National Institute (INCMNSZ) Mexico
09.2002 - 03.2007
Certificate - Course of Drug Development Process and Regulatory Impact
The Greenberg Center
Bachelor of Science - Nutrition
Universidad Veracruzana