Julija Haebe
Schwabhausen
Summary
• Clinical Research experience (11 Years)
• Understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Hands on knowledge of Good Documentation Practices and ICH-GCP Knowledge
• Time/budget/partner/ customer and conflict management and high sense of accountability and urgency
• Ability to establish and maintain culturally sensitive working relationships independently
• Ability to set priorities and handle multiple tasks simultaneously in a changing environment management skills
• Strong consulting, organizational, negotiations and interpersonal skills in a matrix multicultural environment
• Proactive attitude to solving problems / proposing solutions, strategic, out-of-the box thinking and ability to communicate ideas effectively
• proactive team player with a high level of motivation and board range of experience of clinical product development
• enthusiastic for medical innovation and progress, passion for technology
• organization and effective communication experience in workaround solutions
• the efforts of the study team earned sponsor´s trust during successful managed project. The company achieved award for new business (further studies) which will deep the partnership. Leadership faced the highest competition out and came out winners. The study was awarded because of commitment, perseverance and fortitude on the challenging study over 2 years.
• The versatile professional with a diverse skill set, bringing extensive experience in Clinical Research to the table. With a solid background in this area, has consistently delivered exceptional results and contributed to the growth, business win and success of organization.
• As a Central Monitoring Lead, has been conducting trials at all stages from identifying the perfect team, starting the trial and monitoring it all the way down to site closure, splitting responsibilities with Project Managers.
Overview
1827
1827
years of professional experience
1
1
Language
Work History
Clinical Monitoring Lead
Syneos Health GmbH
09.2007 - Current
- CML) role on study since Sep2023:
- Study/site management, study reporting to sponsor/study team, support to other CMs including training and mentoring/learning
- Preparation and attending of project staff/investigator/sponsor meetings, clinical training sessions according to project specific requirements
- CM project scope, budgeted hours and timelines
- Report reviewer for Site Central Assessment Notification (SCAN) since 01 February 2023
- Performing of remote patient data review for Phase I-IV clinical studies to assess compliance with protocol, ICH-GCP, therapeutic indication and monitoring strategy specific to assigned studies and/or all applicable local and federal regulatory requirements
- Conducting of subject and site-level central monitoring activities as per Clinical Monitoring Plan (CMP) in collaboration with DM Data management: remotely review of electronic data eCRFs - Central Monitoring Clinical Review (CMCR), SCAN writing, Key Risk Indicator (KRI Dashboard) Review
- Utilizing of KRI dashboards, metrics and reporting systems and other analytical tools to synthesize data trends, issues, action items in clear and concise presentation of most relevant and actionable items for interpretation by CRAs and other functional roles assigned follow-up
- Site data quality, risks and trends assessment as well as operational performance and summarizing findings for Clinical Research Associate (CRA) review and action planning
- Review and understanding of protocol, critical data and process, safety and data integrity risks related to protocol execution
- Review and assessment of patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviation/violations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data
- Performing of remote patient data review for Phase I-IV clinical studies to assess compliance with protocol, ICH-GCP, therapeutic indication and monitoring strategy specific to assigned studies and/or all applicable local and federal regulatory requirements
- Accomplishments: Maintenance of CM team and 42 sites (over 200 active patients)
- Demonstrated adaptability in responding quickly to changing project requirements or client needs throughout the project lifecycle.
- Increased team productivity by providing ongoing support, guidance, and mentorship to junior staff members.
- Developed comprehensive training materials to improve staff competencies and performance.
- Managed complex projects successfully while adhering to strict deadlines and budget constraints.
- Conducted thorough site assessments to identify potential risks and develop appropriate mitigation strategies.
- Improved risk management strategies through the development of robust risk assessment tools.
- Achieved a high level of customer satisfaction through consistent delivery of exceptional service standards in central monitoring activities.
- Streamlined workflow processes for increased efficiency in central monitoring tasks.
- Built strong relationships with clients, fostering trust in the company''s ability to deliver high-quality services consistently.
- Designed custom reports for key stakeholders that highlighted critical metrics related to trial progress.
- Reported any incidents immediately to local law enforcement.
- Watched both live and recorded video surveillance footage.
- Recorded time, date and location of incidents.
- Investigated prior incidents on CCTV to prepare reports for local authorities.
- Used incident reporting software such as [Software] and [Software] to track daily activities.
- Deployed televising equipment and conducted inspections by directing movement of unit through premises and adjusting camera to diagnose problems.
- Used police databases and computer systems to monitor, record and communicate information to appropriate police personnel.
- Responded quickly to emergency situations to assess and deflect issues.
- Investigated suspicious activities and persons to maintain security of premises.
- Recorded observations and occurrences and interviewed witnesses to complete and submit incident report.
- Conducted training sessions for new security personnel to facilitate compliance with security protocols.
Senior In House CRA I - Senior Central Monitoring Associate I (Sr
Syneos Health Germany GmbH
Munich
09.2020 - 06.2022
- Site management/primary contact in collaboration with the on-site CRA including performance of remote site qualification / site initiation/ interim Site Monitoring Calls (SMCs) and remote close-out visits ensuring regulatory, ICH-GCP and protocol compliance
- Immediately communicated/escalated serious issues to the project team and with guidance develops action plans
- Certified Central Monitor accredited by the International Academy of Clinical Research (IAoCR)
- Maintained high awareness towards safety, damage and loss prevention by conducting 50 training seminars to associates.
CMA II
INC Research
09.2020 - 06.2022
- Responsible for remote monitoring and site management of Phase II-IV clinical research studies
- Managed study site activities to ensure integrity of clinical data is in adherence to all regulations and guidelines, Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and GCP guidelines, Company and Sponsor SOPs
- Maintained current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan
- Responsible for ensuring correct IP/equipment receipt, handling and storage at clinical sites
- Ensures all assigned sites and project-specific site team members are trained of protocol and compliant with applicable study procedures and requirements
- Supporting subject/patient recruitment and retention strategies; collection, review and maintenance of study documents to ensure accuracy, timeliness and completeness of TMF
Clinical Trial Assistant
InVentiv Health FSP for MSD
05.2016 - 09.2016
- Budgeting: collaboration with finance project team for tracking and reporting of negotiations, contract development, approval and maintenance of payments to investigators, vendors, institutions
- Cross functional clerical and administrative support to project teams for Phase I-IV clinical studies and NIS
- Managed small study under project manager supervision
- The strongest resumes quantify results. Consider adding numbers to your achievements. E.g., 'Managed approximately 30 incoming calls, emails and faxes per day from customers.'
Clinical Research Associate
Pharmalog Institut Für Klinische Forschung GmbH
09.200 - 08.201
- Performed regulatory affairs field activities: applications to ethics committee and competent authorities
- Coordinated study documents preparation, collection, tracking (e.g
- Essential documents) for start-up activities Supported preparation of submission package for IRB/ERC and support regulatory agencies submissions
- Responsible for site management and monitoring: feasibility, pre-study/selection/initiation/interim and remote/close-out visits incl
- Reporting in accordance with applicable guidelines, laws, SOPs and monitoring plan
- Trained investigator site personnel on the protocol and regulatory requirements
- Acted as remote visit trainer for less experienced CMAs
- Performed trial and site administration, project specialist functions supporting project manager/project director
- Documented monitoring activities via confirmation letters, follow-up letters, and SMC reports within established timelines
- Archived clinical documents, e.g
- ETMF
- Monitored site performance metrics and with guidance implements action plans for sites not meeting expectations
- Updated clinical trial data bases (CTMS) and trackers
- Continued knowledge development of SOPs, WIs and ICH-GCP requirements; implementing these within all projects
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request
- Hired and trained over [Number] research subjects and monitored progress, answered questions and provided guidance during course of clinical study.
- Set up and disbanded trial study centers to manage clinical study activities for [Number] sites.
Research Scientist
TUM
Munich
09.2001 - 03.2007
- Assisted professor with 2 researched studies including writing of progress reports
- Preparation of presentations in the field of biology over the courses of study
- Techniques: PCR, sequencing, light-, fluorescence-, electron microscopy, separation and purification
- Supervision and training of undergraduate students
- Utilized expertise in microbiology, chemistry, and hematology to help with diagnosis of medical issues.
- Streamlined research processes to meet tight deadlines for multiple projects.
- Maintained a safe working environment by enforcing strict adherence to laboratory safety guidelines.
- Evaluated new technologies for potential integration into existing research processes, driving continuous improvement efforts.
- Streamlined laboratory workflows, resulting in reduced costs and increased productivity.
- Performed preliminary and exploratory data analysis for [Type] studies into [Area of study].
- Completed testing projects by deadline and under budget for company-wide initiatives.
- Recognized abnormal test results and devised corrective actions to retain accurate and valid results.
- Spearheaded cross-functional projects, ensuring timely completion while maintaining high-quality standards.
- Generated data models and performed analysis to produce reports outlining results.
- Enhanced research efficiency by optimizing experimental designs and protocols.
- Developed novel research methodologies for improved data analysis and interpretation.
- Evaluated test results for completeness and accuracy, submitting results to [Type] personnel and support [Type] treatments or diagnostics.
- Established partnerships with industry leaders to secure resources and support for cutting-edge research initiatives.
- Championed knowledge sharing within the organization by organizing seminars, workshops, and training sessions.
- Documented and reported test results after making graphical solutions and representations.
- Used [Software] to determine data-set correlations while initiating qualitative functions.
- Developed case report forms and conducted medical monitoring in partnership with [Type] personnel.
- Researched health and disease prevention infrastructures and models and developed, tested, and marketed [Type] pharmaceutical drugs.
- Maintained confidentiality of all patient information to conform to HIPAA, internal, and other regulatory standards.
- Targeted [Type] research by focusing on specific demographic parameters.
- Provided qualified input and development support for [Type] plans and study protocols.
- Designed experiments using sophisticated statistical techniques, yielding robust results that supported key hypotheses.
- Managed laboratory budgets effectively, allocating funds strategically for maximum impact on research outcomes.
- Contributed significantly to breakthrough discoveries through expert data analysis and interpretation skills.
- Oversaw and developed [Type] projects and component studies.
- Presented research findings at international conferences, increasing visibility and recognition within the field.
- Secured intellectual property protection for groundbreaking inventions through diligent patent application processes.
- Led multidisciplinary teams in solving complex problems, leveraging diverse expertise to achieve innovative solutions.
- Performed [Type] procedures for testing or analysis on [Type] specimens and data sets.
- Mentored junior scientists, fostering professional growth and enhancing team capabilities.
- Performed research into study topics to increase knowledge and to provide valuable contributions.
- Identified opportunities for innovation by staying abreast of emerging trends in the scientific community.
- Mentored junior scientists and graduate students, enriching their research skills and fostering next generation of scientific talent.
- Enhanced team collaboration by implementing centralized data repository, facilitating easier access to research data for all team members.
- Led cross-functional teams in development of patent-pending synthetic molecule, accelerating path to clinical trials.
- Coordinated with regulatory bodies to ensure compliance with ethical standards in human and animal research, upholding integrity of scientific work.
- Spearheaded establishment of new research lab, from design to operational readiness, expanding institution's research capabilities.
- Improved data analysis efficiency with introduction of automated data processing tools, allowing for more rapid hypothesis testing.
- Improved laboratory safety protocols, significantly reducing occurrence of safety incidents during complex chemical experiments.
- Evaluated emerging research technologies, guiding adoption of innovative tools that enhanced experimental capabilities.
- Pioneered use of cutting-edge imaging techniques to uncover previously invisible cellular processes, opening new avenues of research.
- Secured competitive research grants by crafting compelling proposals, ensuring continuation and expansion of critical research projects.
- Enhanced research visibility by presenting findings at international conferences, contributing to global scientific community's knowledge base.
- Contributed to publication of numerous peer-reviewed articles, establishing team as leaders in field of molecular biology.
- Developed novel analytical methods to enhance research accuracy, leading to breakthrough findings in genetic studies.
- Negotiated with suppliers to secure high-quality materials for research at cost-effective prices, maximizing budget efficiency.
- Enhanced public engagement with science through development of accessible and informative research summaries for non-specialist audiences.
- Streamlined laboratory processes, significantly reducing experiment setup times and increasing throughput.
- Optimized resource allocation, ensuring critical experiments were prioritized and adequately funded.
Research Scientist
Taurida Vernadskiy National University
Simferopol
09.1994 - 08.2001
- Neuroscience and behavior research within the group
- Analyzed data and scientific literature, wrote scientific reports
- Attended meetings and symposiums presenting research results
- Supervision and mentoring of university students
- Responsible for laboratory activities and SOPs
- The strongest resumes quantify results. Consider adding numbers to your achievements. E.g., 'Managed approximately 30 incoming calls, emails and faxes per day from customers.'
Pharmaceutical Assistant
Pharmacy
Simferopol
05.199 - 09.199
- Assisted all administrative/sale pharmacy duties
- Maintained equipment and supplies: labeling, counting, weighing medicinal tablets, powders, liquids, mix pharmaceuticals
- Communicated with vendors and clients
- The strongest resumes quantify results. Consider adding numbers to your achievements. E.g., 'Managed approximately 30 incoming calls, emails and faxes per day from customers.'
Education
Master of Science (M.Sc) - Biology and Chemistry
Technical University Munich (TUM)
Munich, Germany11.2007
Diplom Biologist - Biology And Chemistry
Taurida V.I. Vernadskiy National University
06.1999
Skills
- Skills & Interests
- Technical:
- Site Management Dashboard Synopsis Clinical, Clinical Ink (CI), TIBS (Spotfire), electronic CRF platforms and processes: RAVE (Medidata) and Clinical Trial Management System (CTMS)
- Laboratory: dry electrodes/electroencephalogram (EEG); PCR, sequencing, light-, fluorescence-, electron microscopy
- Task Prioritization
- Remote sensing
- Problem-Solving
Interests
mode design, psychology, reading, hiking, archery, dancing and surfing
Timeline
CMA II
INC Research
09.2020 - 06.2022
Senior In House CRA I - Senior Central Monitoring Associate I (Sr
Syneos Health Germany GmbH
09.2020 - 06.2022
Clinical Trial Assistant
InVentiv Health FSP for MSD
05.2016 - 09.2016
Clinical Monitoring Lead
Syneos Health GmbH
09.2007 - Current
Research Scientist
TUM
09.2001 - 03.2007
Research Scientist
Taurida Vernadskiy National University
09.1994 - 08.2001
Master of Science (M.Sc) - Biology and Chemistry
Technical University Munich (TUM)
Diplom Biologist - Biology And Chemistry
Taurida V.I. Vernadskiy National University
Clinical Research Associate
Pharmalog Institut Für Klinische Forschung GmbH
09.200 - 08.201
Pharmaceutical Assistant
Pharmacy
05.199 - 09.199
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