Victoria Lake
Clinical Data Manager II
Port Saint Lucie,FL
Work Preference
Summary
Dynamic Clinical Data Manager with over 13 years of combined experience in healthcare and data management, demonstrating a solution-focused approach and exceptional communication skills. Meticulous attention to detail, with excellent organizational and prioritization abilities, consistently leading to successful deliverable deadlines and quality standards. Proven track record of adapting to changing project needs, effectively juggling multiple high priorities and urgent tasks. Established history of leveraging strong analytical and critical thinking skills to refine data processes, utilize data management tools, and reduce confusion through developing documentation.
Overview
14
14
years of professional experience
7
7
years of post-secondary education
Work History
Clinical Data Manager II
Perceptive (formerly Invicro)
Remote
11.2023 - Current
- Lead and served as point of contact on all data management activities across the life cycle of Phase I-III studies according to SOPs and regulatory compliance guidelines.
- Established all documents within scope related to data management activities for TMF.
- Performed data transfers and facilitate data acquisition, including all data cleaning/reconciliation and maintain a query log.
- Reported to key internal and external stakeholders to discuss study progress and challenges, facilitate transparent communication, and resolve outstanding issues.
- Collaborated cross-functionally to support study design criteria, database functionality, optimize efficiency, and establish timelines to adhere to important milestones.
- Prepared and submitted necessary documentation for regulatory audits, ensuring compliance with FDA and ICH guidelines.
- Provided training and guidance to new CDM team members.
Clinical Data Manager I
Invicro
Remote
08.2022 - 11.2023
- Lead and served as point of contact on all data management activities across the life cycle of Phase I and II studies according to SOPs and regulatory compliance guidelines.
- Developed and maintained clinical databases for accurate data collection and reporting.
- Managed data integrity through routine audits and quality control checks.
- Collaborated with cross-functional teams to streamline data management processes.
- Coordinated with external vendors to ensure timely transfer of clinical data deliverables.
- Developed and maintained comprehensive data management plans, ensuring compliance with regulatory requirements.
Clinical Documentation Specialist
Complete Care
Remote
07.2018 - 08.2022
- Conducted audits of clinical documentation and patient charts to identify areas for improvement and compliance gaps according to Florida statutes, standard medical billing and coding practices, and company SOPs.
- Audited quality and performance procedures by reviewing processes and charts at about 30 facilities.
- Improved clinical documentation quality by conducting thorough reviews and providing feedback to healthcare providers.
- Contributed to above-board revenue optimization by identifying opportunities for appropriate clinical documentation improvement and billing practices.
- Create Life Care Plans to be utilized in litigation on the patient's behalf to secure ongoing treatment and financial compensation where appropriate due to permanent injury.
Certified Chiropractic Physician Assistant
Complete Care
Orlando, FL
01.2016 - 07.2018
- Evaluated and treated musculoskeletal conditions and injuries using advanced chiropractic techniques and therapeutic modalities.
- Collaborated with physicians to create personalized treatment plans to enhance patient recovery and overall health.
- Educated patients on injury prevention and wellness strategies to promote long-term health.
- Conducted digital x-ray examinations as prescribed by the physician.
- Assist physicians in pain management procedures.
Lead Medical Assistant and X-Ray Technician
Integrative Physical Medicine
Orlando, FL
09.2012 - 01.2016
- Created training manuals for new staff to onboard and for new clinical location start-up practices.
- Participated in the opening and set-up of about 20 new office locations.
- Trained and mentored new chiropractic assistants, fostering a collaborative work environment.
- Developed and executed ongoing therapy instruction modules and refresher courses for up to 30 chiropractic assistant staff for weekly and monthly basis trainings.
- Built strong relationships with patients through effective communication skills that foster trust in the clinic's commitment to platinum quality care.
- Assisted healthcare providers with patient examinations and treatments, ensuring adherence to protocols and the patient's care plan.
- Maintained accurate medical records and documented patient health history and ongoing treatment using electronic health record systems.
- Ensured patient safety and comfort during treatment, effectively addressing concerns, answering questions and providing education on therapeutic modalities prescribed by the physician.
- Performed phlebotomy tasks efficiently while ensuring minimal discomfort for patients during blood collection procedures.
- Conducted digital x-ray examinations as prescribed by the physician.
Education
Bachelor of Science - Psychology with a minor in Cognitive Sciences
University of Central Florida
Orlando, FL 08.2006 - 05.2011
Certificate of Technical Studies - Medical Assistant | X-Ray Technician
Central Florida Institute
Orlando, FL 08.2011 - 09.2012
Certificate of Technical Studies - Certified Chiropractic Physician Assistant
Sherman College of Straight Chiropractic
Orlando, FL 01.2015 - 01.2016
Certificate of Completion - Good Clinical Practice
NIDA CTN
05.2022 - 06.2022
Certificate of Completion - Data Management For Clinical Research
Vanderbilt University
05.2022 - 06.2022
Skills
- Clinical data management
- 21 CFR Part 11, GCP, GCDMP, HIPAA
- CDISC/SDTM, MedDRA, WHODRUG, ICD-9/ICD-10 coding, medical terminology
- Electronic data capture
- Time management, decision-making, task prioritization
- Data cleaning, reporting & query resolution
- Clinical documentation
- Proficient in Windows OS, Microsoft Office Suite, video-conferencing platforms
Languages
English
Native or Bilingual
Spanish
Limited Working
Italian
Elementary
Interests
Art, drawing, painting
Reading (Fiction & Non-Fiction)
Visiting state parks and spending time in nature
Studying Spanish and Italian language
Watching Anime, K-dramas, playing video games
Cooking & Baking
Timeline
Clinical Data Manager II
Perceptive (formerly Invicro)
11.2023 - Current
Clinical Data Manager I
Invicro
08.2022 - 11.2023
Certificate of Completion - Good Clinical Practice
NIDA CTN
05.2022 - 06.2022
Certificate of Completion - Data Management For Clinical Research
Vanderbilt University
05.2022 - 06.2022
Clinical Documentation Specialist
Complete Care
07.2018 - 08.2022
Certified Chiropractic Physician Assistant
Complete Care
01.2016 - 07.2018
Certificate of Technical Studies - Certified Chiropractic Physician Assistant
Sherman College of Straight Chiropractic
01.2015 - 01.2016
Lead Medical Assistant and X-Ray Technician
Integrative Physical Medicine
09.2012 - 01.2016
Certificate of Technical Studies - Medical Assistant | X-Ray Technician
Central Florida Institute
08.2011 - 09.2012
Bachelor of Science - Psychology with a minor in Cognitive Sciences
University of Central Florida
08.2006 - 05.2011