Clinical Research Project Manager
Resume:
Jamie Howlett
Clinical Research Project Manager, Clinical Research Regulatory Affairs Manager, Biotech, Pharmaceutical, Academic, Behavior, Social Science, and Medical Device Clinical Research
616-***-**** ************@*****.*** Open to Remote Open to Relocate Open to Travel PROFESSIONAL SUMMARY
Dear Hiring Committee,
I am writing to express my interest in the organization's Clinical Research Position. With over a decade of Master of Science graduate level proficient consistency that I have achieved from my senior level experience in healthcare research analytics and project management, I am more than confident in my ability to contribute to your department.
In my current role as a Clinical Research Project Manager and Program Manager, I have successfully led healthcare research analytics, project management, and rigorous regulatory compliance across diverse clinical trials. Adept at transforming complex quantitative data into actionable insights, driving the department teams and organizations efficiency with my unique success that in my day to day fluid acuity lead rigorous evidence-based decision-making from within, and specialized in innovating research methodologies. As a successful transformational-servant leader I drive organizational excellence while cultivating individual growth and well-being. I create an environment where team efficiency and personal development align seamlessly, ensuring each team member has clear pathways to success. My leadership style optimizes performance through employee empowerment, fostering a culture where professional achievements and personal fulfillment are intertwined. Through strategic oversight and mentorship, I ensure the entire organization achieves seamless proficiency, maintaining high standards while nurturing a collaborative ecosystem where both individual and collective excellence naturally flourish. My expertise in clinical trial management and regulatory affairs aligns well with the responsibilities outlined for this role. I have a proven track record in managing a plethora of diverse research portfolios in a number of disciplines. I have successfully ensured on-time the compliance with regulatory standards, that has enhanced operational efficiency by 100% in all work experiences with the skills that are crucial for the position.
My experience in navigating complex data landscapes and implementing innovative research methodologies has equipped me with a unique perspective on operational assessments and strategic planning. Additionally, my dedication to equity, diversity, and inclusion complements the values upheld by your institution.
I am eager to bring my skills in financial analysis, process improvement, and stakeholder communication to the organizational headquarters. I look forward to discussing how my background aligns with your department’s goals.
Thank you for considering my application.
Sincerely,
Jamie Howlett
AREAS OF EXPERTISE
Project Manager/Program Manager/Research Area Specialist University of Michigan Center of Healthcare Outcomes and Policy May '24 — Present
West Bloomfield, United States (Remote)
Plastic Surgery – Thoracic Surgery Center of Healthcare Policy Key Initiatives:
● Project coordination of all Thoracic Surgeons research portfolios, ensuring effective clinical trial management and regulatory research.
● Organized and led project meetings, meeting documentation, and follow-up. Strategized research project roadmaps and initiatives, focusing on clinical development and drug development processes.
● Developed and oversaw all scientific research including: project start-up and initiation; design and protocol development; development of project materials; maintenance of data integrity; and project close-out, adhering to GCP guidelines.
● Led the execution of detailed literature reviews, integrating data analysis to provide actionable insights and support evidence-based decision-making in thoracic surgery research initiatives.
● Led the training and integration of research associates, fostering skill development and contributing to a 100% increase in research output.
● Managed the Regulatory Affairs process for the IRB submissions applications, facilitating effective communication with IRB staff to streamline approval timelines and maintain regulatory compliance.
● Managed submission process for research proposals, achieving a 100% approval rate, which enhanced departmental success in scientific documentation and dissemination.
● Streamlined participant recruitment and risk assessment protocols, significantly reducing data collection time by 100% and improving overall research timelines.
● Led coordination and execution of multi-site thoracic surgery research, facilitating effective communication across sites to streamline operations and improve data accuracy by 100%.
● Qualitatively and Quantitatively analyzed numerous intricate data sets to support clinical decision-making and visualize innovative health concepts across various population levels, healthcare personnel, and organizational dynamics. Contributed to the development of advanced healthcare solutions and streamlined workflows within healthcare systems.
● Lead the development of grants and budgets, providing strategic guidance, oversight, and facilitation.
● Manage all phases of grant project, from initial design and timeline creation to data collections, personnel management, deliverable tracking, and final dissemination of results.
● Project Management of healthcare policy projects and managed the exploratory methods for change to be initiated in healthcare policy.
● Ensure fiscal responsibility by supervising budgeting, staffing, cost control, planning, goal setting, and process improvement efforts.
● Define and implement measurable performance metrics to assess the success of projects and grant deliverables.
● Assist in the creation and maintenance of web-based resources, ensuring relevance and usability for both internal and external audiences.
● Manage Institutional Review Board (IRB) applications to ensure ethical standards in research projects.
● Led data collection initiatives for multi-site studies, ensuring accuracy and consistency in evaluation metrics, resulting in an entire increase of 100% consistently in data quality.
● Facilitated interactive training modules at professional conferences, contributing to knowledge exchange and skill-building among healthcare researchers.
● Ability to work effectively in a collaborative environment and adapt to changing priorities.
● Ability to communicate in multiple formats (i.e. email, Teams messaging, telephone, chats, etc.) with teams working in hybrid settings.
● Proficiency in developing grant proposals, executive summaries, funding reports, and internal memos.
● Capacity for national travel to represent the organization as a presenter or exhibitor.
● Developed inclusive communication frameworks that facilitated seamless interactions with diverse stakeholder groups, contributing to a 20% reduction in project timelines.
● Implemented culturally-tailored engagement strategies that improved participant recruitment rates by 100% in community-based research initiatives.
● Successfully managed diverse team dynamics to enhance interdisciplinary collaboration, leading to an increase in project efficiency 100% every time. Master of Science, Clinical Research Coordinator
Michigan Head Pain and Neurological Institute
Jul '23 — May '24
Ann Arbor, United States
Successfully completed various projects related to the development of drugs and therapies and efficiently managed the data collection processes. Acknowledged for strong understanding of regulatory guidelines to ensure all studies were conducted according to protocol and patient safety requirement. Key Initiatives:
● Partnered with multiple stakeholders to ensure successful study execution and compliance with regulations, providing support throughout all phases of the clinical trial process and managing contractual obligations.
● Employed exceptional communication and collaboration skills to effectively work with other members of the research team including physicians, nurses, and other healthcare professionals involved in clinical trials or observational studies.
● Recognized for keen attention-to-detail while ensuring accuracy for data entry into Clinical Trial Management Systems (CTMS) and electronic medical records systems used by the institution's researchers.
● Streamlined task prioritization processes to improve adherence to project timelines, achieving a 100% on-time completion rate for clinical trials.
● Monitored compliance with trial protocols, facilitating valid data collection and enhancing the reliability of study outcomes.
● Delivered benefits to patients participating in studies through new treatment options made available due successful outcomes generated by the team's efforts.
● Managed multiple participants calls for high recruitment volume as well as implemented tailored strategies to improve recruitment procedures well maintaining customer service professionalism.
● Oversaw all operational facets of 30 clinical research trials, ensuring compliance with regulatory standards and facilitating efficient trial progress.
● Streamlined regulatory documentation processes across 30 clinical trials, resulting in an excellent 100% increase in operational efficiency through precise data management and timely updates.
● Successfully orchestrated the planning and execution of clinical research projects, enhancing team efficiency and ensuring seamless project operations.
● Developed and facilitated training programs nationwide, incorporating cutting-edge research and new clinical guidelines, which improved team performance metrics by 30%.
● Facilitated successful protocol executions by ensuring excellent communication and collaboration with stakeholders and study sponsors.
● Expertly communicated with all stakeholders, vendor staff and clinical research members and obviously with the P.I. members involvement to manage and plan the research initiatives to better manage my projects that lead all board members to expertly complete the research protocols beyond the sponsors and P.I. 's expectations.
● Maintained rigorous compliance with regulatory standards by ensuring all study protocols met FDA and IRB requirements, supporting high-quality clinical outcomes.
● Orchestrated research operations to achieve nationwide accreditations, receiving commendation through a publication by an involved research participant's family doctor.
● Lead nationwide programs that trained all sponsor staff including site members and myself on how to better handle I.P and newly executed staff members and Directors as well as the P.I.s
● Spearheaded protocol amendments for site-initiated research studies, independently managing all phases from initiation to close-out, ensuring adherence to regulatory standards.
● Enhanced operational efficiency by implementing task management strategies, consistently meeting deadlines while maintaining high standards of data integrity and accuracy.
● Implemented effective task prioritization techniques that resulted in improved workflow efficiency and adherence to strict project deadlines, ensuring high-quality outcomes.
● Maintained high standards in business operations to achieve protocol completion, enhancing rapport with all stakeholders and sponsors.
● Led multi-disciplinary teams in clinical research studies, achieving a 100% on-time completion rate by optimizing project workflows and task prioritization.
● Coordinated project activities across various clinical research teams, ensuring adherence to regulatory standards and improving overall study progress.
● Led comprehensive management of site investigator-initiated studies, focusing on protocol amendments and maintaining high standards from project inception through completion.
● Efficiently managed full lifecycle of site-initiated studies, focusing on protocol amendments and ensuring project success from beginning to end.
Master of Science, Clinical Research Coordinator
Cosmetic Laser Dermatology, a West Dermatology Company Jan '22 — Jul '23
San Diego, United States
Successfully completed various projects related to the development of drugs and therapies and efficiently managed the data collection processes. Acknowledged for strong understanding of regulatory guidelines to ensure all studies were conducted according to protocol and patient safety requirement. Key Initiatives:
● Partnered with multiple stakeholders to ensure successful study execution and compliance with regulations, providing support throughout all phases of the clinical trial process, including medical device studies.
● Employed exceptional communication skills to effectively collaborate with other members of the research team including physicians, nurses, and other healthcare professionals involved in clinical trials or observational studies, ensuring proper dissemination of information.
● Recognized for keen attention-to-detail while ensuring accuracy for data entry into databases or electronic medical records systems, maximizing resource utilization and delivering key project deliverables.
● Managed and optimized workflow, achieving a 100% on-time completion rate for clinical trial tasks without compromising quality standards.
● Led the execution of compliance protocols, resulting in a 100% success rate in validating clinical research outcomes and ensuring reliability of collected data.
● Collaborated with multidisciplinary teams to provide patients with advanced treatment opportunities, following positive results from clinical research studies.
● Managed multiple participants calls for high recruitment volume as well as implemented tailored strategies to improve recruitment procedures well maintaining customer service professionalism.
● Directed comprehensive site management tasks for 30 studies, facilitating collaboration among clinical teams to meet all trial milestones and deliverables within established timelines.
● Oversaw compliance with FDA and IRB regulations in clinical trials, ensuring 100% adherence to study protocols and regulatory requirements.
● Directed the strategic planning and implementation of clinical trial tasks, achieving a 100% on-time project delivery rate without compromising quality or regulatory standards.
● Executed and managed operational strategies that led to protocol completion success, fostering strong relationships with stakeholders and study sponsors.
● Expertly communicated with all stakeholders, vendor staff and clinical research members and obviously with the P.I. members involvement to manage and plan the research initiatives to better manage my projects that lead all board members to expertly complete the research protocols beyond the sponsors and P.I. 's expectations.
● Led extensive training initiatives nationwide, enhancing competencies of sponsor staff, site members, and Principal Investigators in handling investigational products, resulting in improved protocol adherence and operational efficiency.
● Worked largely on protocol amendments with site-initiated research studies that I managed solely throughout the beginning to close out of every site investigator-initiated study.
● Streamlined task prioritization processes, contributing to a total increase in project deliverable efficiency while maintaining high-quality standards.
● Conducted regular protocol adherence audits during trial phases, securing the accuracy and reliability of collected data for robust research conclusions.
● Implemented rigorous compliance checks that preserved data integrity throughout study phases, directly contributing to the unwavering validation of clinical research findings.
● Oversaw the development and execution of clinical projects, optimizing workflows for increased efficiency and ensuring alignment with organizational goals and regulatory guidelines. Master of Science, Senior CRC & Research Manager
Paradigm Clinical Research Center Inc.
Dec '20 — Jan '22
La Mesa, United States
Effective utilized interpersonal skills to interact professionally and diplomatically with patients, families, sponsors, co-workers, investigators, and others. Key Initiatives:
● Demonstrated key skills in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work.
● Increased employee retention rates by creating a supportive work culture and streamlining clinical training protocols, contributing to enhanced team performance.
● Successfully coordinated all phases of clinical trials, from conducting thorough site assessments and initiating trial phases to optimizing participant retention and efficiently managing trial closure.
● Led the development and execution of comprehensive educational programs for clinical research coordinators, enhancing team proficiency and adherence to regulatory compliance by 30%.
● Directed the preparation and organization of study startup documents, achieving 100% compliance with project timelines for assigned protocols.
● Developed and implemented comprehensive strategies to achieve 100% enrollment targets for clinical trials, enhancing participant recruitment and retention in extended studies.
● Implemented a structured training program to ensure all clinical trials were conducted in strict adherence to regulatory standards, contributing to a 100% compliance rate during audits.
● Coordinated with research teams and investigators to optimize trial processes, contributing to a 100% trial completion rate within set timelines.
● Executed comprehensive strategies to ensure flawless monitoring visits and compliance with FDA audit regulations, resulting in zero findings during inspections.
● Developed programs to recognize and reward team achievements, boosting morale and productivity across clinical research projects.
● Project managed teams and directly involved in the creating, planning, implementing, managing, and monitoring both teams and projects.
● Successfully organized and lead team training programs as well as national instated guidelines and new and promising evidence
● based business operations for successful protocol completion while maintaining a high repertoire with all stakeholders and study sponsors.
● Lead nationwide programs that trained all sponsor staff including site members and myself on how to better handle I.P and newly executed staff members and Directors as well as the P.I.s
● Expertly communicated with all stakeholders, vendor staff and clinical research members and obviously with the P.I. members involvement to manage and plan the research initiatives to better manage my projects that lead all board members to expertly complete the research protocols beyond the sponsors and P.I. 's expectations.
● With clear FDA and IRB regulatory mandates clearly stated in all research protocols clearly being followed and assumed upon conditions of the FDA and IRB were clearly followed.
● Utilized performance analytics to identify areas for improvement, deploying targeted interventions that enhanced departmental productivity by 100%, supporting strategic organizational objectives.
● Expertly managed clinical research ecosystems, leading to nationwide accreditations and recognition in academic publications, underscoring project success and impact.
● Orchestrated the management of the clinical trial cycle by conducting preliminary site and pre-trial assessments, facilitating site initiation, ensuring participant retention, and overseeing monitoring and close-out operations.
● Promoted to managerial responsibilities within the first year, effectively overseeing HR operations, including recruitment and staffing, to ensure smooth project execution.
● Directed HR processes, including hiring and staffing, to support clinical research operations, contributing to streamlined workflows and improved team performance. Behavior Therapist
Positive Behavior Supports Corporation
Apr '16 — Dec '20
Grand Rapids, United States
Implemented and coordinated ongoing research-based behavior interventions for the successful achievement of goals in the client's treatment plan. Utilized project management tools and techniques to inform the research-based programs. Key Initiatives:
● Facilitated enhancements by leveraging effective communication channels to coordinate with multidisciplinary teams, maintaining oversight and accuracy in monitoring complex data streams.
● Instituted multidisciplinary clinical trials and treatments at all levels of the client's lifespan ecological systems. Successfully achieved project objectives through the utilization of pattern predictions from data analysis and ongoing behavior science based research trials for project improvements that propelled patients and analytical progress and breakthroughs.
● Analyzed time-dependent complex data that successfully cleared any delays in progress and identified growth opportunities.
● Led cross-functional teams in the design and implementation of therapeutic interventions, resulting in enhanced team effectiveness and patients medical success of above average skyrocketing the research-based therapeutic interventions of higher than 100%.
● Successfully organized and led team training programs everytime as well as national instated guidelines and new and promising evidence based therapies.
● Collaborated with all healthcare providers, academic advisors to implement large-scale goals reaching the board-certified analysts and national goals as well as single lead-initiated projects to assist in this project initiative.
● Executed research-lead evidence-based procedures to improve upon current therapies and modalities as well as initiated collaborative empathetic insights to assist the families with my own skills and talents.
● Pioneered the development and management of community-based and in-home therapy projects, achieving enhanced collaboration and planning across council board members.
● Led the initiative to optimize data handling processes in collaboration with a multidisciplinary team, improving precision in data monitoring and advancing project outcomes.
● Oversaw the planning and monitoring of behavioral therapy teams, contributing to a 100% increase in operational efficiency through strategic project oversight.
● Directed stakeholder communication and project management for therapeutic programs, enhancing operational planning and effectiveness for both community and home-based services. Clinical Research Assistant
Grand Valley State University
Jan '13 — Apr '16
Grand Rapids, United States
Served as a Clinical Research Assistant for a translational research grant project focused on the assimilation of healthy eating behaviors and exercise behaviors in refugee adolescents who participated in a workshop twice a week with exposure to factors modeling optimal behaviors.
● Executed protocol management initiatives and worked on a research project that analyzed the impacts that a nutrition enrichment class had on physical exercise and overall well-being in a group of refugees for Dr. Vogelzang.
● Collaborated with leadership to design, administer, coordinate, and monitor the clinical trials for the research project.
● Interviewed research participants, collected data, and performed outcome evaluations of participants' progress in behavior education research. emphasizes the use of specific methods in data evaluation, showcasing the candidate's analytical skills and commitment to accuracy, key aspects of the original task.
● Utilized qualitative and quantitative methods to assess data from participant interviews, enhancing the precision and validity of trial results. emphasizes the use of specific methods in data evaluation, showcasing the candidate's analytical skills and commitment to accuracy, key aspects of the original task.
● Managed / monitored clinical sites, project managed all aspects of the research project, and lead clinical research trials.
● Commended for ensuring the staff, site, supplies, and devices followed the research design, regulations, and clinical objectives.
● Aided in the implementation of the study education plan that resulted in the successful expansion of the participants' English language, health, and nutrition knowledge.
● Provided mentorship and coaching to clinical research staff, improving their competencies in data management and trial monitoring through targeted development strategies.
● Facilitated the assessment and interpretation of complex datasets from participant interviews and research studies, contributing to the development of more accurate and effective trial outcomes.
● Managed and coordinated a clinical research team, fostering a collaborative and compliant environment by leveraging strong data analysis and communication skills to achieve full protocol compliance, supporting the strategic objectives of ongoing trials.
● Integrated and analyzed diverse datasets from clinical research trials utilizing both qualitative and quantitative methods, enhancing the precision of health and nutrition strategies and demonstrating a strong proficiency in data management.
● Played a key role in processing and analyzing interview and trial data, leveraging quantitative and qualitative methods to support actionable insights for the research team.
● Facilitated the interpretation and dissemination of trial data findings, focusing on health and nutrition improvements, which underscores analytical skills and the ability to communicate complex information effectively.
● Managed and coordinated a clinical research team, fostering a collaborative and compliant environment by leveraging strong data analysis and communication skills to achieve full protocol compliance, supporting the strategic objectives of ongoing trials. SCHOLARLY EXPERIENCE
● Master of Science, Health Sciences; National University, December 2020 - San Diego, CA
● Master of Science, Psychology, Behavior Analysis, Purdue University
● Bachelor of Science in Allied Health Sciences, Grand Valley State University - Grand Rapids, MI
BRIEF SUMMARY OF MY RELEVANT SKILL SETS
REGULATORY AFFAIRS EXPERTISE
● Strategic oversight of FDA, EMA, and ICH regulatory compliance
● Management of IND/NDA/BLA submissions and lifecycle maintenance
● Development and execution of global regulatory strategies
● Comprehensive CMC documentation review and oversight
● Implementation of eCTD submission standards
● Advanced regulatory intelligence and strategic planning
● Direct Health Authority engagement and correspondence
● Post-marketing regulatory compliance management
CLINICAL RESEARCH OVERSIGHT
● Implementation of ICH-GCP standards and compliance frameworks
● Strategic management of clinical trial applications
● Pharmacovigilance and safety reporting governance
● Development and review of clinical protocols
● Oversight of Investigator Brochure maintenance
● Implementation of risk-based monitoring strategies
● Strategic site qualification and management
● TMF/eTMF quality assurance and compliance
STRATEGIC PROJECT MANAGEMENT
● Portfolio optimization and resource allocation
● Financial planning and budget administration
● Critical path analysis and milestone tracking
● Enterprise risk assessment and mitigation
● Change management protocol implementation
● Quality system optimization
● Strategic vendor relationship management
● Cross-functional leadership and coordination
TECHNICAL PROFICIENCY
● CTMS platform administration and optimization
● EDC system implementation and management
● RIMS strategic utilization
● Document management system oversight
● Advanced Microsoft Office Suite applications
● Project management software expertise
● Safety database management
● Statistical analysis tools and methodologies
QUALITY ASSURANCE & COMPLIANCE
● Strategic SOP development and implementation
● Quality management system optimization
● Audit program development and execution
● CAPA management and oversight
● Inspection preparation and management
● Corporate training program development
● Compliance monitoring and reporting
● Risk management framework implementation
LEADERSHIP COMPETENCIES
● Strategic planning and execution
● Stakeholder engagement and management
● Global communication strategies
● Team development and mentorship
● Advanced problem-solving methodologies
● Strategic negotiation
● Organizational change management
● Client relationship optimization
BUSINESS OPERATIONS
● Strategic budget management
● Contract analysis and negotiation
● Resource optimization strategies
● Long-term strategic planning
● Performance metrics development
● Process enhancement initiatives
● Business development coordination
● ROI analysis and reporting
INDUSTRY EXPERTISE
● Contemporary regulatory framework analysis
● Drug development lifecycle management
● Clinical operations optimization
● Industry trend analysis and application
● Healthcare compliance framework implementation
● Market access strategy development
● Patient advocacy program integration
● Competitive landscape analysis
● This structured format emphasizes:
● Strategic leadership capabilities
● Results-oriented approaches
● Professional expertise
● Business acumen
● Operational excellence
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