Tatiana Marcal
Highland Park,IL
Summary
Versatile clinical research professional with over 14 years of extensive experience in clinical research operations, project and program management in industry, academia and private practice. Proven ability to lead cross-functional teams, develop and implement study protocols, and ensure regulatory compliance. Adept at collaborating with global stakeholders, managing budgets, and maintaining high scientific and ethical standards.
Overview
14
14
years of professional experience
2
2
Certifications
Work History
MANAGER, EXTERNAL RESEARCH
AMGEN | HORIZON THERAPEUTICS
07.2018 - 04.2024
- Successfully managed multiple global clinical trials simultaneously across multiple therapeutic areas ensuring all operational aspects of clinical studies from start-up through final clinical study report (CSR).
- Established effective project management practices that streamlined workflows, improved resource allocation, and expedited timelines for study completion.
- Collaborated with medical affairs teams to develop scientifically sound protocols that aligned with business objectives while meeting regulatory standards.
- Optimized clinical trial operations through continuous process improvements, leading to increased efficiency and cost savings.
- Spearheaded interdepartmental collaboration for improved communication and resource sharing in clinical research projects.
- Reduced study start-up timelines by effectively collaborating with cross-functional teams and implementing efficient processes.
- Drove efficiency gains in the management of clinical trials by leveraging data analytics to inform decision-making processes and optimize resource allocation.
- Conducted thorough site assessments and selected optimal locations for conducting clinical trials, ensuring compliance with regulatory requirements.
- Reduced operational costs through effective budget management, negotiation with vendors, and careful allocation of resources.
- Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
- Fostered strong relationships with investigative sites, vendors and CROs, leading to increased collaboration and improved study outcomes.
- Developed training materials for site staff to enhance their understanding of the study program, resulting in improved adherence to requirements.
- Facilitated open communication channels between internal teams and external partners, fostering collaboration toward common goals in successful clinical trial execution.
- Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
LEAD CLINICAL RESEARCH COORDINATOR
STANFORD UNIVERSITY
03.2017 - 07.2018
- Managed multi-site clinical studies, ensuring timely completion and compliance with regulatory standards.
- Managed budgetary aspects of clinical trials, negotiating contracts with vendors and ensuring cost-effective resource allocation.
- Collaborated with investigators to develop innovative clinical trial designs, optimizing data collection methods for better results.
- Played a key role in the successful submission of regulatory applications by ensuring all study documentation was accurate, complete, and compliant with relevant guidelines.
- Streamlined regulatory submissions by developing efficient processes and documentation templates.
- Conducted site initiation visits, monitoring visits, and closeout visits to ensure protocol adherence and accuracy.
- Implemented risk-based monitoring strategies that led to reduced onsite visit frequency without compromising data integrity or patient safety.
- Developed robust data management plans for efficient data capture, analysis, and reporting throughout the study lifecycle.
- Ensured data integrity in clinical trials by implementing rigorous quality control measures and closely monitoring study progress resulting in a no-findings FDA audit for a pivotal medical device trial.
- Assisted in manuscript preparation highlighting key findings from clinical trials, advancing the field's understanding of novel treatments and interventions.
- Mentored junior clinical research coordinators in best practices for trial management, fostering professional development and growth within the team.
CLINICAL RESEARCH COORDINATOR II
STANFORD UNIVERSITY
08.2014 - 03.2017
- Responsible for the successful completion of numerous studies by coordinating all aspects of trial initiation, execution, and close-out activities.
- Managed study budgets and resources to maximize return on investment while maintaining quality standards.
- Conducted thorough literature reviews supporting the development of innovative study designs and methodologies.
- Contributed to improved patient outcomes by providing valuable input on the development of new clinical trial protocols and methodologies.
- Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Served as a liaison between site personnel, investigators, and sponsors to ensure clear communication throughout the trial process.
- Facilitated clinical trial progression, effectively managing multiple projects simultaneously.
- Ensured compliance with regulatory requirements by conducting thorough audits of study documents and procedures.
- Optimized patient safety during clinical trials by diligently monitoring adverse events and promptly escalating concerns when necessary.
- Assisted in drafting comprehensive research reports summarizing findings, conclusions, and recommendations for further action.
- Assisted in the preparation of scientific manuscripts based on clinical trial findings for publication in peer-reviewed journals.
- Provided mentoring, assistance, and training to all new staff members to ensure proper training and completion of all certification requirements.
SENIOR CLINICAL RESEARCH COORDINATOR
SAN FRANCISCO CLINICAL RESEARCH CENTER
03.2012 - 08.2014
- Managed and coordinated the operations of multiple complex clinical studies in a private practice research setting.
- Spearheaded internal quality assurance initiatives aimed at improving overall practice performance related to patient care, data management, staff training, and regulatory compliance.
- Improved practice revenue through effective financial management and strategic cost reductions.
- Increased patient enrollment in clinical trials by developing targeted recruitment strategies and outreach programs.
- Established effective monitoring systems to track progress and identify potential issues in ongoing clinical trials.
- Recruited, hired and trained all staff, providing direct supervision, ongoing staff development and continuing education to employees.
CLINICAL RESEARCH COORDINATOR
SAN FRANCISCO CLINICAL RESEARCH CENTER
04.2010 - 03.2012
- Maintained high ethical standards in research practices, adhering to Good Clinical Practice guidelines and safeguarding patient rights.
- Facilitated rapid resolution of complex issues related to study conduct or patient safety concerns through effective problem-solving skills.
- Ensured site readiness for audits and inspections by maintaining a well-organized, detailed, and accurate study documentation system.
- Increased protocol compliance by providing comprehensive training and support to study team members.
- Optimized efficiency in managing investigational product inventory levels while minimizing waste through meticulous tracking processes.
- Advanced scientific knowledge in the field of clinical research by attending relevant conferences, workshops, seminars, and other educational opportunities regularly.
- Increased patient retention rates by establishing strong relationships with participants through effective communication and followup.
Education
M.D. -
Pavlov First Saint Petersburg State Medical University
Russian FederationSkills
- Technical Skills: Project management, operations management, strategic planning, budget management, vendor management, protocol development, regulatory submissions, clinical data analysis, eTMF implementation and management, data visualization (dashboards)
- Soft Skills: Critical thinking, collaborative approach, effective communication, presentation skills, cross-functional team leadership
- Software Proficiency: Microsoft Office, EDC Systems, CTMS, Veeva Medical, SharePoint, Canva, Visio, Microsoft Project
Websites
Certification
- Board Certified Medical Affairs Specialist (BCMAS), Accreditation Council for Medical Affairs (ACMA)
- Certified Professional (ACRP-CP), Association of Clinical Research Professionals (ACRP)
Timeline
MANAGER, EXTERNAL RESEARCH
AMGEN | HORIZON THERAPEUTICS
07.2018 - 04.2024
LEAD CLINICAL RESEARCH COORDINATOR
STANFORD UNIVERSITY
03.2017 - 07.2018
CLINICAL RESEARCH COORDINATOR II
STANFORD UNIVERSITY
08.2014 - 03.2017
SENIOR CLINICAL RESEARCH COORDINATOR
SAN FRANCISCO CLINICAL RESEARCH CENTER
03.2012 - 08.2014
CLINICAL RESEARCH COORDINATOR
SAN FRANCISCO CLINICAL RESEARCH CENTER
04.2010 - 03.2012
M.D. -
Pavlov First Saint Petersburg State Medical University
Similar Profiles
Kerri BobnarKerri Bobnar
Patient Access Liaison at Amgen (Horizon Therapeutics)Patient Access Liaison at Amgen (Horizon Therapeutics)
Jamie BullJamie Bull
Rare Disease Account Manager at Amgen (Formally Horizon Therapeutics)Rare Disease Account Manager at Amgen (Formally Horizon Therapeutics)
Valerie R. SilvaValerie R. Silva
Regional Account Manager/ Clinical Science Associate at Amgen (acquired Horizon Therapeutics)Regional Account Manager/ Clinical Science Associate at Amgen (acquired Horizon Therapeutics)