BRIGID T. CONWAY

Work History

Senior Clinical Trial Manager

Syndax

04.2023 - 12.2024

Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
Collaborated closely with biostatisticians for accurate statistical analysis planning in support of study objectives.
Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
Reduced operational costs through effective budget management, negotiation with vendors, and careful allocation of resources.
Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial.
Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
Contributed to protocol development, ensuring a well-designed study that met research objectives while adhering to ethical standards and regulations.
Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
Followed informed consent processes and maintained records.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Maintained compliance with protocols covering patient care and clinical trial operations.
Complied with research protocols by providing ongoing quality control audits.
Monitored unit budget to meet financial objectives for spend rate and funding.

Global Study Manager

Genentech

08.2021 - 07.2022

Collaborated with quality assurance teams to ensure all aspects of study adhered to strict regulatory guidelines at every stage.
Participated in quality assurance reviews to verify accuracy and reliability of data.
Built complex data analysis reports and provided timely feedback to stakeholders.
Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
Worked with programming to coordinate Study Data Tabulation Model maps.
Established strong relationships with key stakeholders, facilitating open lines of communication and fostering collaborative working environment.
Conducted thorough data analysis, providing valuable insights and recommendations for improving future studies.
Implemented risk management strategies to proactively identify potential issues before they became critical problems during course of studies.
Led regular status update meetings with internal teams and clients, ensuring transparency and alignment on project progress.
Worked closely with clinical operations teams to ensure smooth implementation of study protocols at participating sites, resulting in high levels of patient enrollment and retention.
Streamlined communication between cross-functional teams, resulting in improved collaboration and timely completion of studies.
Enhanced study efficiency by implementing effective project management strategies and tools.
Developed detailed study plans and timelines to ensure all project milestones were met within budget constraints.
Drove continuous improvement initiatives across organization by sharing best practices learned from managing various studies over time.
Collaborated with medical teams to create uniform standards for clinical data reporting.

Senior Clinical Program Manager

SeaGen

02.2020 - 07.2021

Coordinated internal audits to ensure adherence to established quality standards and regulatory requirements throughout program operations.
Negotiated contracts with vendors to secure competitive pricing for essential goods and services related to program success.
Developed and maintained strong relationships with key stakeholders, ensuring successful collaboration on clinical initiatives.
Implemented onboarding for new employees, which enabled each to effectively learn tasks and job duties.
Implemented new policies and educated staff on changes.
Handled job duties for staff members which were unavailable or out of office.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Complied with research protocols by providing ongoing quality control audits.
Collected, evaluated, and modeled collected data.
Collaborated with multidisciplinary teams to develop best practices for patient-centered care delivery models..

Senior Study Manager, Oncology

Daiichi Sankyo

01.2018 - 02.2020

Mentored junior staff members, contributing to their professional growth and enhancing team performance overall.
Presented findings from completed studies at industry conferences or through publication in peer-reviewed journals, showcasing expertise in specific therapeutic areas or methodologies employed during research work conducted.
Maintained up-to-date knowledge on industry trends and regulations, ensuring compliance throughout all stages of the study process.
Coordinated with external vendors to optimize resources and ensure seamless integration into the overall study strategy.
Developed detailed study plans and timelines to ensure all project milestones were met within budget constraints.
Conducted thorough data analysis, providing valuable insights and recommendations for improving future studies.
Managed diverse study portfolios, balancing competing priorities for successful execution of multiple projects simultaneously.
Implemented risk management strategies to proactively identify potential issues before they became critical problems during the course of studies.
Drove continuous improvement initiatives across the organization by sharing best practices learned from managing various studies over time.
Worked closely with clinical operations teams to ensure smooth implementation of study protocols at participating sites, resulting in high levels of patient enrollment and retention.
Collaborated with medical teams to create uniform standards for clinical data reporting.

Senior Clinical Program Manager

Oncobiologics, Inc.

09.2015 - 01.2018

Presented progress reports and findings at conferences, showcasing the organization''s commitment to cutting-edge research and clinical excellence.
Optimized resource allocation by identifying synergies across multiple clinical programs, leading to cost savings and improved patient care.
Negotiated contracts with vendors to secure competitive pricing for essential goods and services related to program success.
Streamlined documentation processes to enhance data integrity and reduce the risk of errors in patient files.
Streamlined program management processes for improved efficiency and reduced operational costs.
Implemented innovative strategies to increase patient engagement, leading to higher satisfaction rates and better health outcomes.
Developed and maintained strong relationships with key stakeholders, ensuring successful collaboration on clinical initiatives.
Managed budgets and resources effectively, ensuring the successful execution of multiple clinical programs simultaneously.
Spearheaded interdisciplinary collaborations, leveraging diverse expertise to solve complex challenges faced by patients enrolled in clinical programs.
Established clear communication channels across all levels of project involvement, facilitating timely updates on project status or changes.
Communicated effectively with staff members, physicians, and patients, employing active listening and interpersonal skills.
Identified opportunities to improve clinical practices, devised strategies and implemented plans to increase patient care standards and enhance operational procedures.

Associate Director of Clinical Operations

ContraVir Pharmaceuticals Inc.

02.2015 - 07.2015

Led teams of up to 5 personnel, supervising daily performance as well as training and improvement plans.
Fostered a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
Prioritized tasks and allocated resources appropriately to keep teams focused and productive.
Mentored junior staff members, providing guidance on professional development opportunities and career progression paths within the company.
Assisted senior leadership in managing all aspects of operations.
Reduced operational costs by identifying inefficiencies and implementing cost-saving measures in various departments.
Evaluated employee performance and conveyed constructive feedback to improve skills.

Clinical Trial Head

Novartis Pharmaceuticals

02.2014 - 12.2014

Self-motivated, with a strong sense of personal responsibility.
Worked effectively in fast-paced environments.
Skilled at working independently and collaboratively in a team environment.
Proven ability to learn quickly and adapt to new situations.
Excellent communication skills, both verbal and written.
Worked well in a team setting, providing support and guidance.
Demonstrated respect, friendliness and willingness to help wherever needed.
Worked flexible hours across night, weekend, and holiday shifts.
Used critical thinking to break down problems, evaluate solutions and make decisions.
Learned and adapted quickly to new technology and software applications.
Developed and maintained courteous and effective working relationships.
Demonstrated strong organizational and time management skills while managing multiple projects.

Clinical Trial Manager, Hepatology/Gastroenterolog

Schering-Plough Research Institute (Merck 2009)

10.2005 - 11.2013

Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial.
Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
Reduced operational costs through effective budget management, negotiation with vendors, and careful allocation of resources.
Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
Contributed to protocol development, ensuring a well-designed study that met research objectives while adhering to ethical standards and regulations.
Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Maintained compliance with protocols covering patient care and clinical trial operations.
Complied with research protocols by providing ongoing quality control audits.
Monitored unit budget to meet financial objectives for spend rate and funding.

Clinical Program Manager

Duramed Research

11.2002 - 09.2005

Oversaw regulatory compliance efforts, minimizing risk and maintaining a positive reputation among industry partners.
Coordinated internal audits to ensure adherence to established quality standards and regulatory requirements throughout program operations.
Managed budgets and resources effectively, ensuring the successful execution of multiple clinical programs simultaneously.
Optimized resource allocation by identifying synergies across multiple clinical programs, leading to cost savings and improved patient care.
Collaborated with multidisciplinary teams to develop best practices for patient-centered care delivery models.
Established clear communication channels across all levels of project involvement, facilitating timely updates on project status or changes.
Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment.
Delivered effective onboarding and training to new and existing employees and cross-trained staff members in other job roles to maximize coverage.

Clinical Manager PII/PIII Global Oncology Studies

Protarga Inc

10.2001 - 09.2002

Worked with nurse manager to develop nursing staff through education, evaluation, performance management, and competency improvement.
Delivered effective onboarding and training to new and existing employees and cross-trained staff members in other job roles to maximize coverage.
Oversaw overall operation of nursing services and patient care.
Contributed to successful accreditation reviews with thorough preparation efforts focused on documentation completeness.
Communicated with patients, asked appropriate questions, and employed active listening to determine best care.
Provide ongoing case management to patients to implement appropriate treatment plan, adhere to quality models and maximize utilization of services needed to achieve optimal outcomes.
Facilitate hiring of qualified [Department Name] personnel by interview applicants and making recommendations for employment.
Managed [Number] employees with various personalities and from different cultures for large [Number]-physician practice.
Reduced hospital readmission rates by prioritizing discharge planning and effective communication between patients, families, and healthcare providers.
Implemented new policies and educated staff on changes.
Handled job duties for staff members which were unavailable or out of office.
Managed daily operations of [Number]-person clinic supporting approximately [Number] patients per week.
Developed interdisciplinary care plans with input from physicians, nurses, therapists, and other healthcare providers for optimal patient results.
Oversaw hiring, onboarding, and evaluation of nursing staff, contributing to a high-performing team environment.
Created work schedules for [Number] employees and oversaw functioning of billing department.
Implemented quality improvement initiatives that led to measurable improvements in patient satisfaction scores.
Streamlined clinic operations for increased efficiency by optimizing patient flow and appointment scheduling processes.
Monitored all phone calls and scheduled appointments.
Selected, promoted and terminated staff members.
Reviewed operational policies and recommended solutions and change to medical director.
Maintained up-to-date knowledge of industry trends and best practices to inform ongoing improvements in clinical management strategies.
Optimized inventory management systems to ensure availability of critical supplies.
Enhanced patient care standards by developing and implementing comprehensive training for nursing staff.
Enhanced communication with patients and their families to provide more personalized care plans.
Organized professional training workshops on latest healthcare technologies and practices.
Established patient feedback system to identify areas for service enhancement.
Negotiated with suppliers to secure cost-effective purchasing agreements for medical equipment.
Spearheaded implementation of electronic health records system, enhancing efficiency and data accuracy.
Facilitated community health initiatives to promote wellness and disease prevention.
Developed partnerships with local healthcare providers to expand patient access to specialized services.
Achieved significant reduction in medication errors through rigorous overhaul of drug administration protocols.
Coordinated multidisciplinary team meetings to streamline patient care plans, improving overall treatment outcomes.
Updated infection control protocols, significantly reducing incidence of hospital-acquired infections.
Reduced patient wait times by optimizing clinic scheduling procedures.
Conducted comprehensive audits of clinical practices, identifying areas for quality improvement.
Led transition to telehealth services, ensuring uninterrupted patient care during challenging times.
Fostered culture of continuous improvement, leading to more effective patient care strategies.
Oversaw compliance with healthcare regulations and standards, maintaining full accreditation status.
Streamlined patient admission and discharge processes, enhancing patient satisfaction and operational efficiency.
Implemented cost-saving measures without compromising on quality of patient care.
Maintained compliance with protocols covering patient care and clinical trial operations.
Reviewed referral information and kept track of intakes from various referral sources.
Gathered, processed, and shipped lab specimens.
Monitored unit budget to meet financial objectives for spend rate and funding.
Complied with research protocols by providing ongoing quality control audits.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Facilitated focus group sessions with project patients.
Collected, evaluated, and modeled collected data.

Clinical Trial Manager

Omnicare Clinical Research

03.2001 - 10.2001

Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Gathered, processed, and shipped lab specimens.
Complied with research protocols by providing ongoing quality control audits.
Collected, evaluated, and modeled collected data.
Reviewed referral information and kept track of intakes from various referral sources.
Facilitated focus group sessions with project patients.
Monitored unit budget to meet financial objectives for spend rate and funding.

Summary

Overview

Work History

Senior Clinical Trial Manager

Global Study Manager

Senior Clinical Program Manager

Senior Study Manager, Oncology

Senior Clinical Program Manager

Associate Director of Clinical Operations

Clinical Trial Head

Clinical Trial Manager, Hepatology/Gastroenterolog

Clinical Program Manager

Clinical Manager PII/PIII Global Oncology Studies

Clinical Trial Manager

Education

Master of Science - Biology (Oncology)

Bachelor of Science - Biology

Bachelor of Arts - Chemistry

Skills

Timeline

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