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clinical data manager resume example with 4+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
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Summary

CORE STRENGTHS & TECHNICAL SKILLS Clinical Data Management Profession oriented with 3 + years of experience excelling as a Clinical Data Manager, Clinical Data Manager PROFESSIONAL SUMMARY: Ability to create detailed DM project instructions and documents like CRF Completion Guidelines, database design documents, edit check specifications, Data Review Plan. Proven involvement with observing and conveying information for assigned projects in different clinical trials and phases in timely manner with highest priority given to clean and quality data. Strong understanding of the Study Data Tabulation Model (SDTM) data structure. Experience in clinical trials phases 1- 4, from early phase development exploring safety and efficacy to late phase clinical development and different therapeutic areas of clinical trials within the pharmaceuticals and Biotechnology industry. Excellent understanding of ICH GCP Guidelines, GCDMP & 21 CFR Part 11, Good Documentation Practices (GDP), clinical research, related regulatory requirements and nomenclatures. Experience in Team management, Vendor management, Client interaction and communicating with different departments within the clinical research domain. Profound experience in CRF designing, Edit checks creation and User Acceptance Testing (UAT) performance. Extensive knowledge in different stages of clinical data management including study start-up, study conduct, and study close out. Developed and maintained Data Management Plans (DMP), Data Review Plan (DRP), change control log (CCL), CRO oversight plan and overviewed the project's life cycle Knowledge with medical coding on MedDRA and WHO Drug along with NDA submission. Experience in developing Data Transfer Agreement (DTA)/DTS with external vendors. Good working knowledge of clinical practice and medical terminology. Extensive work experience in data validation, Discrepancy management, Central Lab data reconciliation and SAE reconciliation and Third-party/Vendor data reconciliation. Experience with the process of Database QC and CRF tracking. Also manages/ reviewed Trial Master file (TMF /eTMF) for audit preparation. Experience in J-Review, Microsoft Office, and Microsoft Project. Experience in understanding of SAS Data Review listings, Patient profiles, SAS edit checks for manual data review, Data handling guidelines, coordinated data review for ISS and ISE. Excellent written, verbal, organizational, interpersonal, and communicational skills with ability to accept constructive feedbacks. Ability to work well with technical and clinical team members and collaborate with entire clinical team (CRAs, Safety, Biostatistics, etc.) Ability to work independently, accept and act with appropriate accountability with minimal guidance.

Skills
  • Clinical Data Skills
  • ECS, TMF, CCG, UAT, CRF specification, edit check documentations, QC, DTA/DTS, RECIST
  • Study Tools & Clinical Database
  • Medidata RAVE, Inform & Oracle Clinical (RDC), CLINTRIAL, Grail EDC, imednet EDC, IWRS, CTMS, SAS, SAS Enterprise
  • Guide.
  • Extra- curriculum Skills
  • Written and Verbal communication skills, project management skills, computer skills, and database skills, EMR/EHR software,
  • Microsoft Office Suite: Outlook, Microsoft Excel, projects
  • Therapeutic Areas
  • Oncology, Cardio-vascular diseases, Respiratory, gastro- intestinal disorders, Pulmonary, Neurology, Dermatology, Ophthalmology, Hematology, CBSDH Pharmacokinetic and
  • Pharmacodynamic.
Experience
Clinical Data Manager, 04/2022 to 03/2023
American College Of RadiologySilver Spring, MD,
  • Performed trainings on study trial for EDC, IWRS and create user guides
  • Responsible for creating, revising, appropriate versioning and maintaining data management documentations
  • Assisted in defining and/or creating data listings, summary table validation, data specifications and/or data management audit
  • Oversee vendor data reconciliation (e.g., IVRS, laboratory data, SAE Reconciliation) within the clinical databases to include QC of queries/query responses, manual listings, external data reconciliation, and custom reports as required throughout the study
  • Coordinates with the EDC programmers and/or 3rd party vendors in the setup and testing of electronic data capture (EDC) technologies such as Interactive Response Technology (IRT), electronic patient reported outcomes (ePRO), and electronic clinical reported outcomes (eCOA) as required per the scope of work
  • Oversee on reconciling of AE/SAE data in Safety DB and/or Data Management DB
  • Developed and reviewed Data Management SOPs, WIs, and training materials
  • Serves as a Data Operation Mentor and oversees system development and Modifications
  • Coordinated with coding data review/approvals using MedDRA and WHO-DD
  • Managed with budgeting forecasting hours and potential budget impacts, setting study metrics for indirect reports, while promoting collaborative cross functional building
  • Maintain internal data management study documentation to audit ready status
  • Review and comment on draft protocol
  • Led team by providing inputs into the preparation of the investigator meetings based on business need and management decisions
  • Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level
  • Coordinates with Technical Design and Clinical Programming team as well as Project Management to develop and maintain DM startup timelines including the development, testing completion of all data capture tools
  • Regularly review quality of data output ensuring all data created meets integrity, quality, validity, and reliability standards and is collected, compiled, tested, and reported on in accordance which project and sponsor guidelines, industry best practices and regulatory standards
  • Liaise with sponsors, sites, and project teams to address data issues and queries; ensure stakeholders remain current on project requirements and manage sponsor expectations
  • Oversee and collaborate with CROs in development of Data Management documents including DMPs, Completion Guidelines, eCRFs, DTA/DTS, UAT Plan and related documents, CRF
  • Completion guidelines and other documentation as required
  • Manages performance and quality issues with vendors (FSP and 3rd party data providers such as labs) and escalates to DM Portfolio Lead, DM management
  • Develops appropriate risk mitigation, as needed
  • Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project
  • Represent Data Management in internal study team, KOM clients and CRO meetings
  • Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to manager any requested out of scope activities.
  • Led training and educational activities for entire staff from physicians to administrative personnel.
  • Worked with physicians and nurses to find methods to improve quality of patient health documents and records.
  • Interviewed and hired talented performers, bringing exemplary expertise and knowledge to job positions within organization.
  • Put new coding and billing procedures into practice, which helped to reduce number of claims that insurance companies denied.
Clinical Data Manager, 05/2021 to 04/2022
American College Of RadiologyReston, VA,
  • Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing
  • Well- experienced in Direct Sponsor/CRO interaction in meetings KOM and Client meetings
  • Lead the Coordination of up-versioning medical dictionaries across multiple studies
  • Review of SDTM mapping, define
  • Xlm, reviewers guide to ensure these are audits and submission ready
  • Lead the development and coordination of data, data review and documentation for level Integrated safety summary (ISE) and Integrated Efficacy summary
  • Verified reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requests
  • Review study documents from legacy studies to ensure these are audit and/or submission ready
  • Represented Data Management at Bid Defense Meetings (BDM) where I prepared project-specific slide presentation from DM template functional slides in collaboration with DM management
  • Also, participates in BDM preparation meetings including discussing overall DM strategy collaborating with Manager as required
  • Participate in the review of Clinical Research documents (e.g., Protocols, Case Reports Forms, Reports and Statistical Analysis Plan)
  • Investigate/research data questions from statistics or third- party vendors
  • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
  • Develop Case Report Form (CRF), electronic and/or paper
  • Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
  • Develop Interactive Web-based Randomization System (IWRS)
  • Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, statistical analysis plans, and CRF (eCRF) completion / monitoring conventions
  • Develop database (DB) clinical trial data specifications, user requirements, user requirements, edit rules/checks, query logic and data validations
  • Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
  • Coordination of eCRF build and Validation documents, included but not limited to edit check document, issue logs, UAT Summary reports
  • Performed reconciliation of electronic data transfers from vendor to sponsor
  • Engage and diíect píoduct owneís and otheí suppoíting íoles foí all systems, data models and tools within clinical data ecosystem
  • Manage all phases of data management activities and support to internal project teams, Clients, and Clinical Research Organization (CRO) including the following:
  • Create, review, and approve study startup documents, eCRF/Database specifications, Edit Check specifications, Data Management Plan (DMP), UAT Plan and related documents, CRF Completion guidelines and other documentation as required
  • Supervise data cleaning activities including processing queries, performing ongoing data review, and orchestrating scheduled cross-functional data review/reconciliation, identifying issues, data trends and tracking them through resolution
  • Implement data cleaning plan and assisted in data review, including the freezing and unfreezing of patient data within the EDC
  • Represent Data Management in internal study team, client and CRO meetings
  • Assist DM oversight role/manager in monitoring timelines and managing resources to meet timelines
  • Identify inconsistencies and inefficiencies in data management processes and recommend solutions
  • Ensures the consistency of data system compliance by following the established guidelines of national and international regulatory authorities.
  • Led training and educational activities for entire staff from physicians to administrative personnel.
  • Worked with physicians and nurses to find methods to improve quality of patient health documents and records.
  • Interviewed and hired talented performers, bringing exemplary expertise and knowledge to job positions within organization.
  • Put new coding and billing procedures into practice, which helped to reduce number of claims that insurance companies denied.
Clinical Research Associate, 01/2021 to 05/2021
Children's Hospital Of The King's DaughtersVarious Locations, VA,
  • Facilitated in conducting clinical trials and monitoring their progress
  • Also performed site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory
  • Write Reports and Investigator Follow-up Letters for Site Visits, Site Selection Visits, Site Initiation
  • Visits, Interim Monitoring Visits and Site Close-out Visits
  • Reviews study protocols and assisted site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner
  • Generated / populated dashboards with weekly / monthly data management study specific metrics
  • Track record in fostering productive collaborations and working relationships
  • Conduct and facilitate specific start-up activities such as Site Regulatory Package (SRP) review and approval, and Informed Consent (ICF) customization and negotiation (where required), and IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures
  • In Coordination with senior scientist in drug development worked to design and execute or oversee studies performed in-house and at CMO’s to improve product performance and maximize shelf life
  • Builds and maintains strong working relationship with CRO/CMO partners ensuring that activities are managed collaboratively, efficiently, and effectively
  • Worked collectively with research, technical, and clinical leads to operationalize and conduct Digital Medicine clinical trials and contributed to achieving project tasks and goals and escalated observed deficiencies and issues to clinical management expeditiously, proposes solutions and follow all issues through to resolution
  • Aid in the development and maintenance of Standard Operating Procedures (SOPs) and assisted with clinical checklists to ensure compliance with good clinical practice, regulatory agencies, Institutional Review Boards (IRBs)
  • Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
  • Provided Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
  • Worked with technical leads on collecting clinical study data using mobile/sensor-based technologies of interest to the research team
  • Ensured consistency of the safety narrative strategy for clinical trials with that of the program; overseed writing of safety narratives
  • Responsible for providing operational support to teams from study startup to study execution
  • Worked independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation
  • Prepared accurate and timely trip reports and performed other duties as assigned by management.
  • Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Clinical Research Intern, 06/2017 to 07/2019
Regions HospitalStillwater, MN,
  • Exposed to the principles and application of good clinical practice and research regulations
  • Developed, coordinate, and implemented research and administrative strategies to successfully manage assigned protocols
  • Recruited subjects for all assigned protocols within timelines given by Director of Clinical Operations or Site Director Responsible for knowing target goal for enrollment and enrollment period
  • Handled actively screening, eligibility, registration, scheduling, visit conduct, data entry, and specimen processing for subjects enrolled to multiple complex therapeutic oncology trials
  • Provided oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex in nature like procedural and interventional studies
  • Designed, implemented, and optimizes methods for handling IP
  • Provided consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties and guidance to patients through a research protocol
  • Experienced in Order supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging, and laboratory handling manuals, etc.)
  • Evaluated processes to identify issues related to recruitment and retention rates and offered varied solutions while working closely with the Principal Investigator (PI) and study team to recruit, screen and enroll participants for studies.
  • Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Education and Training
Master of Science: Project Management, Expected in 01/2023 to University of Cumberland, Graduate School of Management And Science - Williamsburg, KY
GPA:

Management | Project Risk and Quality Management Concentration

MHA: , Expected in 07/2022 to Valparaiso University, College of Nursing and Health Professions - Valparaiso, IN
GPA:
Health care Management | Quality Health care Concentration
Lean Six Sigma Green Belt Training Certificate: , Expected in 09/2020 to - ,
GPA:
Prevention of and Fight Crime Program (ISEC): , Expected in 08/2019 to - ,
GPA:
Bachelor of Dental Surgery (B.D.S: , Expected in 09/2018 to Modern Dental College and Research Center, Graduate School of Dentistry, DAVV University - Indore,
GPA:
Certificate of Internship in department of dentistry: , Expected in 07/2018 to - ,
GPA:
Certificate of Clinical Research and healthcare: , Expected in 07/2017 to - ,
GPA:
Masters: Health care Administration/Management, Expected in to - ,
GPA:
MHA: , Expected in to Valparaiso University - Valparaiso, IN
GPA:
Masters: Project Management, Expected in to - ,
GPA:
M.S: , Expected in to University of Cumberland - , KY
GPA:
Bachelors | Bachelor of Dental Surgery (B.D.S): , Expected in to DAVV University - Indore,
GPA:

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Resume Overview

School Attended

  • University of Cumberland, Graduate School of Management And Science
  • Valparaiso University, College of Nursing and Health Professions
  • Modern Dental College and Research Center, Graduate School of Dentistry, DAVV University
  • Valparaiso University
  • University of Cumberland
  • DAVV University

Job Titles Held:

  • Clinical Data Manager
  • Clinical Data Manager
  • Clinical Research Associate
  • Clinical Research Intern

Degrees

  • Master of Science
  • MHA
  • Lean Six Sigma Green Belt Training Certificate
  • Prevention of and Fight Crime Program (ISEC)
  • Bachelor of Dental Surgery (B.D.S
  • Certificate of Internship in department of dentistry
  • Certificate of Clinical Research and healthcare
  • Masters
  • MHA
  • Masters
  • M.S
  • Bachelors | Bachelor of Dental Surgery (B.D.S)

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