Sara Fedorchak
Batavia,Ohio
Summary
Experienced Data Manager with proven system development and database design skills. Effective team builder adds value to any organization in need of great collaboration, interpersonal and multitasking abilities. Meets tight deadlines, through effective collaboration with colleagues and establishes strong client relationships. Passionate about clinical research and drug development process
Overview
31
31
years of professional experience
Work History
Lead Clinical Data Manager
Worldwide Clinical Trials
Cincinnati, OH
03.2023 - Current
- Lead each of the data management projects to which assigned; provide leadership to the corresponding data management teams
- Represent WCT Data Management in all discussions with Sponsors with respect to the aspects of the projects to which assigned.
- Liaise with the Director, Data Management at regular intervals to discuss progress and any issues outstanding
- Oversee staff training for all projects to which assigned; both direct involvement in training and supervision of staff assigned to training
- Collaborate with corresponding teams in other WCT departments working on the same project.
- Ensure that all data management operations are conducted in accordance with SOPs; contribute to the ongoing revision/improvement of these SOPs.
- Oversee timely database build, study updates, and database locks for all assigned projects.
- Create and review project specific documentation for assigned trials, i.e. the Data Management Plan, CRF and eCRF completion guidelines, and Data Transfer Agreements.
- Write specifications for the database build, modification of database, manual and SAS edit checks for assigned projects.
- Perform verification and User Acceptance Testing of configured databases. validate Database and Edit check Specifications, Manual and SAS checks.
- Implement processes for reconciliation and perform reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory)
- Support and oversee all data cleaning activities for assigned projects
- Produce information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendor.
- Liaise with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees (CEC) within clearly defined guidelines for matters concerning processing of data.
- Ensure that adequate QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects.
Sr. Associate Clinical Data Management
PPG
Remote FSP Employee , OH
10.2022 - 02.2023
- Detect and resolve data quality issues and discrepancies for integrity and quality control.
- Develop process improvements and identifies database issues.
- Adhere to company, contract, and regulatory requirements when performing data management activities
- Collaborate with cross-functional team to meet critical deadlines and data analysis
- Adhere to standard operating procedures to perform quality control audits.
- Create study specific reports and visualizations to present requested data metrics
- Strictly adhere to GCP guidelines to ensure overall data integrity is maintained
- Present data management updates and presentations during internal and external sponsor meetings
- Provide excellent service and attention to internal and external teams
Sr. Clinical Data Management Associate
CTI Clinical Trials and Consulting
Covington, KY
11.2016 - 10.2022
- Manage consultants, delegate assignments, and conduct study specific training.
- Ensure accuracy of clinical databases as compared to the CRF and the result of any data queries
- Collaborate with project management and Clinical teams on development of project scope and study timelines.
- Perform data analysis and created reports to identify trends or discrepancies in the data.
- Maintain records of changes made to databases and updated relevant documents accordingly.
- Collaborate with internal teams and sponsor representatives on project specific CRF design for optimal data collection, and effective database design.
- Create, review, and update CRF and eCRF completion guidelines, and guidance documents.
- Perform verification and User Acceptance Testing of configured databases.
- Provide support and conduct data cleaning, and vendor reconciliation for assigned projects
Clinical Data Associate II
CTI Clinical Trials and Consulting
Covington, KY
- Participate in team meetings to improve workflows and contribute to more accurate data capture
- Provide technical guidance and training on EDC systems usage within team members and externally with clinical sites.
- Assist in developing processes to improve efficiency of data collection, entry, review and reporting.
- Perform quality control checks on all clinical data entered into the database.
- Conduct audits of source documents to verify accuracy of collected data.
- Provide support for electronic data capture systems.
- Coordinate data reconciliation with external vendors providing services related to clinical trial activities.
- Generate queries related to discrepancies in protocol deviations or missing and incorrect values in the database.
- Participate in user acceptance testing sessions for EDC system upgrades.
- Approach customers and engage in conversation through use of effective interpersonal and people skills.
- Work successfully with diverse group of coworkers to accomplish goals and address issues related to products and services.
- Maintain open communication with team members and stakeholders, resulting in successful project outcomes.
Sr In House Clinical Research Associate
CTL Clinical Trials and Consulting
Covington, KY
- Assist in development and maintenance of project-related tracking for protocol deviations, serious adverse events (SAEs), and safety reports
- Perform monitoring activities related to clinical trials while adhering to all applicable regulatory and SOPs
- Conduct remote site initiation visits (SIVs), interim monitoring visits (IMVs), or close-out visits (COVs investigator selection and qualification process by offering professional input
- Assist with study start-up activities, including site selection and remote pre-study visits (PSVs) to identify and evaluate potential Investigators Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Complete site visit reports in accordance with client / project team expectations; completed visit / telephone contact reports in Clinical Trial Management System (CTMS)
- Collect, and submit regulatory documents for investigative sites including assisting project CRA with reconciliation of Trial Master File (TMF) / electronic TMF (eTMF)
- Attend investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Collaborate effectively with other teams to ensure study success.
Clinical Monitoring Associate
INC Research
Cincinnati, OH
01.2015 - 01.2016
- Serve as primary Contact for sites on assigned phase II-IV clinical research studies
- Conduct remote monitoring visits inclusive of monthly site management calls.
- Submit timely and complete visit reports per SOP and sponsor requirements
- Provide guidance to site personnel and PI through required training and ensured compliance with protocol, regulatory guidelines, and study procedures.
- Attend Investigator meetings, project team meetings, and clinical training sessions according to project requirements and continuing to develop solid understanding of drug development process, GCP, and relevant regulations.
- Mentor less-experienced CMAs
Ongoing Review Coordinator /Submissions Specialist
Schulman Associates IRB
Blue Ash, OH
01.2012 - 01.2015
- Ensure all site-submitted review information was complete, accurate, and met review restriction criteria and timelines.
- Serve as primary site contact, and liaison through IRB to facilitate effective and collaborative interaction site personnel to collect required regulatory documentation.
- Review and Prepare Periodic / Final Review submissions, Revised Protocols, Amendments, Addendums, Investigator letters, Informed Consents (ICFs), and Investigator Brochure (IB) revisions for internal board review
Study Coordinator and Recruitment Specialist
Apex Eyecare
Fairfield, OH
01.2010 - 01.2012
- Assure patient care protocols and clinical trial operations comply with GCP/ICH Guidelines and organization SOPs.
- Responsible for study participant recruitment, protocol adherence, documentation of study specific procedures, and accurate data entry in EDC database
- Oversite of query resolution, data clarification, and timely study data entry
Special Procedures /Cardiac Cath Lab Technologist
The Christ Hospital
Cincinnati, OH
01.1993 - 01.2007
- Assist physicians with cardiac catheterization and surgical procedures, including pre and post-procedure patient care.
- Collaborate with other members of the healthcare team to provide exceptional patient care.
- Work successfully with diverse group of coworkers to accomplish goals and address issues to provide excellent patient care and healthcare services
- Record observations and baseline measurements to maintain accurate medical records.
- Produce contrast-enhanced radiographs of heart and cardiovascular systems with help of diagnostic imaging equipment.
- Provide excellent customer service by effectively communicating with patients, families, staff and staff in other hospital departments.
- Ensure compliance with hospital policies related to infection control, radiation safety, and hazardous waste management.
Education
BBA - Business Administration and Management
Wilmington College
Blue Ash, OH08-2012
Associate of Applied Science - Medical Radiologic Technology
Chattanooga State Technical And Community College
Chattanooga, TN08-1991
Skills
- Database Development
- Data Migration
- Report Development
- Quality Assurance
- Database Analysis
- Data Testing
- Writing Queries
- Database Administration
- Troubleshooting
Therapeutic Experience
- Bone Marrow Transplant
- Cardiology
- Ophthalmology
- Oncology / CAR-T / Medical
- Otolaryngology
- Hematology
- Infectious Disease
- Stem Cell Transplant
- Solid Organ Transplant
- Vaccine Development
- Gene Therapy
- Nephrology
- Sleep Apnea
- Women's Health
References
References available upon request.
Timeline
Lead Clinical Data Manager
Worldwide Clinical Trials
03.2023 - Current
Sr. Associate Clinical Data Management
PPG
10.2022 - 02.2023
Sr. Clinical Data Management Associate
CTI Clinical Trials and Consulting
11.2016 - 10.2022
Clinical Monitoring Associate
INC Research
01.2015 - 01.2016
Ongoing Review Coordinator /Submissions Specialist
Schulman Associates IRB
01.2012 - 01.2015
Study Coordinator and Recruitment Specialist
Apex Eyecare
01.2010 - 01.2012
Special Procedures /Cardiac Cath Lab Technologist
The Christ Hospital
01.1993 - 01.2007
Clinical Data Associate II
CTI Clinical Trials and Consulting
Sr In House Clinical Research Associate
CTL Clinical Trials and Consulting
BBA - Business Administration and Management
Wilmington College
Associate of Applied Science - Medical Radiologic Technology
Chattanooga State Technical And Community College
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