Clinical Data Specialist Resume Sample
Jannie Zemlak
104 Jaylon Vista,
New York,
NY
+1 (555) 760 0068
Work Experience
Clinical Data Specialist
09/2015
-
PRESENT
Boston, MA
- Conducts ongoing outreach and engagement to support program delivery
- Participates in all scheduled trainings
- Represents UT Southwestern at community and outreach events targeted teen pregnancy
- Coordinates scheduling with host sites and other program partners, as needed
- Submits reports, data, and other required documents to the, Project Ntarupt in a timely fashion on behalf of UT Southwestern; and
- Clinical data management experience in pharmaceutical industry and/or contract research organization
Senior Clinical Data Specialist
03/2009
-
06/2015
New York, NY
- Work with the Center Laboratory Team to ensure reporting features and functions are available
- Coordinate efforts with Systems Owners and User
- Attend Center Platform at meetings and functions
- Assist with facilitating and coordinating the smooth flow of communication by acting as a liaison
- Maintain and exercises center development practices
- Basic MS Office skills and knowledge of one or more Clinical Database Management Systems and CRF design and an understanding of Clinical Trials Development process is required
- To assist with patient-related activities
- Documents all relevant information in the infant’s medical records
- Updates the program’s electronic tracking system to maintain accurate records for all infants under established procedures and processes
Education
Walla Walla University
2004 - 2009
Bachelor's Degree in Social Work
Professional Skills
- Excellent organization skills and demonstrated attention-to-detail
- Excellent communication and interpersonal skills with great attention to detail
- Excellent written and verbal communication skills, with the ability to work well in multi-faceted teams
- Experience (0-2 years of experience with Masters)
- Experience pulling data from several different sources with the purpose of preparing analytical reports with variances for management
- Excellent judgment, critical thinking, and problem solving
- Applied knowledge and experience using tools/methods to perform clinical data abstraction, quality improvement, clinical outcomes research and analysis
How to write Clinical Data Specialist Resume
Clinical Data Specialist role is responsible for design, database, integration, training, security, oncology, reporting, events, government, software.
To write great resume for clinical data specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Data Specialist Resume
The section contact information is important in your clinical data specialist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Clinical Data Specialist Resume
The section work experience is an essential part of your clinical data specialist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous clinical data specialist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical data specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Data Specialist resume experience can include:
- Excellent Organizational Skills and ability to develop processes to improve workflow
- Excellent written and verbal communication skills, ability to establish rapport
- Experience in data abstraction or hospital experience in data collection
- Problem solve, attention to details and multi-task effectively, and meet deadlines in a fast-paced environment
- Effectively communicate with trial submitters to address requests/questions/concerns, develop solutions to problems, and clearly document actions taken
- Demonstrated clinical experience and/or in-depth knowledge of clinical trials
Education on a Clinical Data Specialist Resume
Make sure to make education a priority on your clinical data specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical data specialist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Clinical Data Specialist Resume
When listing skills on your clinical data specialist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical clinical data specialist skills:
- Effectively manage and lead projects by applying project management methods and skills
- Experience working under Good Clinical Practices, Good Clinical Data Management Practices, and other FDA regulations and guidelines is required
- Work effectively and productively without close supervision and to exercise independent judgment in decision making
- Computer skills to include: word processing, spreadsheets, graphics and relational databases
- Experience (0 years of experience with Masters) with clinical database systems
- Intermediate to advanced skills and knowledge in adhoc data reporting, creating data review listings, and metrics reporting
List of Typical Experience For a Clinical Data Specialist Resume
1
Experience For Senior Clinical Data Specialist Resume
- Team player who effectively works with colleagues and business partners
- Assist Quality Assurance in regulatory certifications (ISO, Data Privacy, etc), validation processes, and SOP writing
- Administrative experience in a hospital or medical setting
- Define and test new measures, validate data and take steps to automate and improve the data collection process
- Review and resolve data discrepancies for standardized data validation systems and procedures
- Excellent knowledge of medical terminology, anatomy and physiology
- Work independently with strong sense of focus, task-oriented, nonjudgmental, open personal qualities, clear sense of boundaries
2
Experience For Clinical Data Specialist Supv Resume
- Experience (2+ years with Masters) with clinical database systems
- Self motivated with strong sense of accountability
- Adhering to all University of Pennsylvania, GCP, ICH, and FDA guideline
- Establish complex record-keeping procedures, including cross-indexing by several factors and the designing of necessary forms
- Identify and select usable data from extremely subtle and complex data patterns, applying practical understanding
- Report to clinic staff on patients outcomes, including overall clinic screening, response and remission rates
3
Experience For Clinical Data Specialist Resume
- Train database End Users (internal and external users) on the database and/or maintain automated database training system
- Capture and maintain Database and Systems training records
- Follows and implements data management standards and best practices and assures Standard Operating Procedures are followed for Data Management activities
- Abstracts and analyzes data from medical records, EMR or other electronic tools using the appropriate guidelines
- Provides accurate and timely information for public reporting to internal customers as well as other external agencies
4
Experience For Senior Clinical Data Specialist Resume
- Maintains or exceeds productivity and quality according to established standards
- Perform Enhanced Monitoring functions
- Assist with the development and maintenance of training documents for clients in sync with new system releases
- Analyzes, aggregates, and reports clinical data for communicating clinical performance metrics
- Keep current in changes and innovations in clinical knowledge, user applications, and reporting requirements in the field of blood and marrow transplant
5
Experience For Clinical Data Specialist Supv Resume
- Select and apply appropriate formulas, computer programs, or applications depending on data content
- Assist with cystic fibrosis clinical research including pharmaceutical and investigator driven studies
- Collects and triages medical laboratory results from the section’s laboratory in accordance with parameters set forth by the Scientist
- Responsible for telephone and written reporting of medical laboratory results, their interpretation, associated risk assessment and next-step actions to the health care provider in accordance with SOP
- Responds to external queries for newborn screening results or result interpretation in light of stated clinical concern by caller
6
Experience For Clinical Data Specialist Resume
- Documents all reports and relevant clinical information in the infant’s record to ensure record is accurate and timely
- Performs concurrent chart reviews for complex cases and presents findings to physicians to demonstrate documentation opportunities and assist in future physician-led documentation initiatives
- Develops and promotes collaborative processes and strong working relationships with physicians and other health care professionals to accomplish program goals and ensure exceptional documentation. Key processes include
- Attend Clinical Project Team meetings to gather business need requirements and translate to technical requirements
- Partner with other shared service functions such as Safety, Core Lab, etc. to gather business need requirements and translate to technical requirements
- Identify, analyze, propose solutions, and effectively resolve complex data issues by exercising appropriate judgment and collaborating with the clinical project team members and other shared service functions
- Assists in FDA and Quality audits that involve Clinical Database and Data Management
- Lead development and quality control (QC) of data management documents including data management plans, data review guidelines, and database validation protocols
7
Experience For Senior Clinical Data Specialist Resume
- Contribute to the development of data management standards and process documents
- Accountable for the accuracy and completeness of the clinical data collected
- Understand how source data is collected and processed end-to-end to guarantee its accuracy
- Collaborate with internal stakeholders including IT, Compliance and Quality to ensure source system enhancements are maintained and monitored to ensure complete and accurate data is provided to Executive Office of Health and Human Services (EOHHS) and Centers for Medicare & Medicaid Services (CMS)
- Responsible for activities of clinical trial data management including query generation/processing, reconciliation of CRF and electronic data, and database cleaning activities
- Assist in developing systems for organizing data to analyze, identify and report trends
- Data Analyses: Create data sets from internal and external data sources, perform statistical programming and analyses under the guidance of the senior biostatistician; learning new statistical techniques, support writing of manuscripts for peer reviewed journals
- Study Enrollment Tracking Responsibilities: Develop and implement recruitment tracking methods for 40-50 study sites. Monitoring enrollment milestones and create and present reports to research team, lead investigators, and study sponsors
- Support and communicate with principal investigators, co-investigators, project manager, and other coordinators as needed for the successful execution of the clinical trials
8
Experience For Clinical Data Specialist Supv Resume
- Manages data management issues by reviewing protocols for cross-project consistency, and identifying standard Case Report Form (CRF) modules to meet objectives
- Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review
- Design and implement clinical protocols and data collection systems
- Develops data quality plans
- Provide early strategic input into protocol design focused on data management issues
- Inputs data into computer programs to facilitate the transmission to needed sources
- Works with various EMR data to help create best practices and procedures
9
Experience For Clinical Data Specialist Resume
- Support the management team and other internal customers to ensure timely and accurate delivery of data
- Participate in regular staff meetings, staff training programs, supervisory sessions, and accept the responsibility for aiding the development of positive team relationships as requested
- Adhere to AHF policy, procedures and the professional code of ethics
- Function independently and as a team player in a fast paced environment
- Development and entry of Specimen Test Plans (STP)
- Codification of Informed Consents based on company SOP’s
- Assist in preparation of annual update of global Regulation and Guidance documents
- Perform quality control reviews of clinical trial summary reports and ensure that they accurately and consistently represent cancer clinical protocols and related documentation
- Review trial report feedback from diverse sources and address areas requiring data or process improvement
10
Experience For Senior Clinical Data Specialist Resume
- Lead the implementation of process improvement initiatives, including revision of SOPs
- Collaborate with developers to request application changes and perform user acceptance testing
- Implement clinical data transformations using database ETL tools. Specify complex transformations and work with Programmers to implement
- As part of the data standards committee, help maintain organizational data standards for clinical data collection, management, and reporting
- Execute data update projects in a timely manner
- Work closely with the Scientific Team Manager to provide overall guidance to team members on daily tasks
- Collaborate with internal and external stakeholders to facilitate the structuring of trial eligibility criteria to best support matching of participants to clinical trials
- Serve as a team liaison in high-level meetings to support customer goals, clarify expectations, and address data quality concerns
- Efficiently troubleshoot and report any unexpected technical problems
List of Typical Skills For a Clinical Data Specialist Resume
1
Skills For Senior Clinical Data Specialist Resume
- A solid understanding of regulatory issues and the use of Standard Operating Procedures as they relate to the Clinical Public Health Lab
- Experience working in a physician practice setting as a CMA, LPN, or clerical field
- Solid understanding of clinical terminology, regulations, GCP, GDP,
- Experience using Surginet and/or Cerner
- Experience working with relational databases
2
Skills For Clinical Data Specialist Supv Resume
- Experience in a clinical setting, preferably pediatric
- Experience working in clinical trials, laboratory, or specimen management
- Experience with issue tracking systems and process documentation
- Experience working with data documentation formats such as CSV, JSON, and XML
- Set priorities, coordinate multiple tasks, organize tasks, and maintain control of workflow
- Pharmaceutical, biotech, medical device and/or diagnostic industry experience
- Previous related experience Willingness and ability to be cross trained in new clinical knowledge
- Work experience
- Strong drive for process optimization and data integrity
3
Skills For Clinical Data Specialist Resume
- Experience with oncology structured clinical trial eligibility criteria
- Sitting/standing/moving about intermittently during working hours
- Understanding of clinical trial search interfaces and patient trial matching
- Developing ability to contribute and/or interpret protocol to create CRFs and edit check specifications
- Facilitate regular provider rounds with the consulting psychiatrist on patients enrolled in MBC to ensure that appropiate care is being provideded
- Works independently and as an integral team member to assist with reporting newborn screening results
4
Skills For Senior Clinical Data Specialist Resume
- Review cancer clinical trial documents for the NCI CTRP and create trial summary reports according to standard operating procedures (SOPs)
- Prepares for and ensures database lock is achieved according to project timelines and criteria specified in the Data Management Plan
- Basic knowledge and understanding of principles of quality improvement, patient safety, database data entry or management, and statistical principles
- Analyze and interpret data to assist in decision-making
- Provide ongoing support and subject matter expertise for all data management related activities
- Rarely writing by hand
- Proficiency with using EDC databases, preferably Clindex
5
Skills For Clinical Data Specialist Supv Resume
- Knowledge of cancer terminology, staging, biomarkers, and NCI Thesaurus
- Expertise using Microsoft Excel
- Work with clinical operations team to facilitate project implementation onsite at participating clinics
- Educate clinic staff on the importance of screening depression
- Assist in collection and processing of blood and urine samples
- Confers with physicians and nurses to obtain statistical information concerning subjects when they have tests performed or receive treatment elsewhere
- Utilizes the Program’s electronic tracking system to assist with
6
Skills For Clinical Data Specialist Resume
- Adheres to data definitions provided by database’s governing body and remains aware of nationally recommended changes
- Communicates newborn screening results and respective follow up needed to appropriate health care providers
- Prepares materials to facilitate the reporting of out-of range laboratory results to infants’ health care providers
- Understand the capabilities of the clinical systems including sources of data and intended purpose
- Work with Analysts on assigned Star measures and understand the complexities of the Star /HEDIS programs in providing accurate data for submission
- Continuous Quality Improvement of data collection methods and analysis for efficiency and process streamlining purposes
- Computer proficiency in MS Office products (eg, Microsoft Project, Excel,
- Assist in writing or reviewing Data Management Plan (DMP), Data Validation Plan (DVP) and Data Transfer Specifications (DTS). Reports trends to Clinical Operations colleagues and management; escalates potentially troublesome trends to management; works with Statisticians to understand their analysis requirements and their data quality requirements
7
Skills For Senior Clinical Data Specialist Resume
- Data Governance: interacts with service providers that provide data feeds supplementary to the clinical database management system; factors this external data into the Data Management Plan and Database Lock Plan
- Clinical Database setup and modification: develops and/or oversees the development of trial data specifications, including eCRF design, database requirements, eCRF completion guidelines and edit rules in collaboration with cross functional groups
- Assist in cross-functional review meetings for the data specifications and eCRF design; Performs UAT activities. Data standards: stays current with development and current thinking about data collection
- Stays current with data collections standards with respect to CDISC, especially CDASH standards. Keeps abreast of industry trends to efficiently capture data from clinical trials using electronic data capture systems (EDC), clean the data, and lock databases in a timely manner,
- Assist in Writing and updating Standard Operating Procedures (SOPs) as needed
- Provides data management input for all clinical trial synopses and protocols prior to the design and implementation of EDC databases. Ensures electronic case report forms (eCRFs), eCRF completion instructions, and data validation specifications are completed prior to implementation of EDC databases
- Able to independently prioritize multiple projects/tasks and reliably meet deadlines
8
Skills For Clinical Data Specialist Supv Resume
- Able to translate clinical information for a lay audience
- Able to collaborate in a multifunctional team environment
- Comprehend moderately complex written materials (i.e. technical manuals, medicolegal documents, etc.)
- Write Data Review Guidelines and Study Management Report Requirements
- Perform Data Review and Discrepancy Management in an Electronic Data Capture system
- Oversee Data Review by offshore contractors
9
Skills For Clinical Data Specialist Resume
- Expert Level with Microsoft Excel and Access
- Clinical knowledge in the field of oncology or blood and marrow transplantation
- Successful completion of education program as defined by the National Cancer Registrars’ Association
- Certification as a Certified Tumor Registrar (CTR) from the National Cancer Registrars’ Association or CTR eligible
- Proficient with Microsoft Access and Microsoft Excel
10
Skills For Senior Clinical Data Specialist Resume
- Knowledge of IRB and Human Research Protection Regulations
- Working knowledge of electronic data capture systems, database design, and data management required. Preference given to candidates with demonstrated knowledge and programming experience in UNIX, R, SQL, and PYTHON
- Follow detailed clinical research protocols
- General knowledge of clinical study lifecycle from protocol design to database development and study closure
- Experience building transformation pipelines using modern ETL tools such as IBM InfoSphere DataStage, Pentaho/Kettle, SQL Server Integration Services, or other
List of Typical Responsibilities For a Clinical Data Specialist Resume
1
Responsibilities For Senior Clinical Data Specialist Resume
- Working with study teams, lead the definition and documentation of per study operational data tables. Ensure that they are aligned with organizational data standards
- Exercise independent judgment with strong analytical capabilities
- (c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or
- (d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records
- Advises on performance metric reporting and clinical benchmarking related to quality and medical staff initiatives
2
Responsibilities For Clinical Data Specialist Supv Resume
- (b) Directly interacting with or caring for human-subjects research participants
- Define and document per study clinical data transformations, primarily from data collection formats like CDASH to the operational data formats like SDTM+-
- Test derived data tables to ensure compliance with published specifications
- Work with IT to identify and recommend enhancements to the database ETL toolset
- Collects clinical data for inclusion within a specific clinical database in support of organizational quality and safety initiatives
3
Responsibilities For Clinical Data Specialist Resume
- Manages and maintains assigned clinical database. Serves as primary liaison with third-party vendors, database end users, and clinical decision support department
- The Associate is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; or extensive reading
- The Associate is not substantially exposed to adverse environmental conditions; job functions are typically performed under conditions such as those found in general office or administrative work
- Responsible for successful reporting on multiple projects to improve the patient experience. Keeps manager informed of project status
- Gathers and analyzes data to establish appropriate action plans, requirements, and updates
4
Responsibilities For Senior Clinical Data Specialist Resume
- Collaborate with stakeholders and subject matter experts in the design, collection, and analysis of data
- Assures timely submission of data, and correspondence to all customers (internal/external) for efficiency, improve quality, safety, and the overall patient experience in the patient care areas
- Resolves data discrepancies and reconciles within specified timeframes
- Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or a leadership role in a specific area or process on a large study with guidance
- Run daily reports to identify casesin each category
- Develop new tools to assist with data collection and analysis
- Provide support to data management staff over the course of the study
- Prepares data of any new research study for Institutional Review Board and informed consent for subject'sfamilies
5
Responsibilities For Clinical Data Specialist Supv Resume
- Current Texas State Licensure as an Registered Nurse
- Proficient in Microsoft Office: Excel, Outlook, Word and PowerPoint
- Work in well lighted, ventilated areas
- Ensure patients are monitored (in-person, via telephone, or through communicationwith clinical staff) for changes in depression severity and medication side effects
- A good understanding of the clinical research life cycle process,
6
Responsibilities For Clinical Data Specialist Resume
- Reports any evidence of toxicity to drugs or chemicals used in treatment of subjects
- Attend weekly VitalSign6 team meetings and perform other dutes as needed
- Recruit and consent research study subjects
- Coordinate schedules/appointments and monitor progress
- Distribute study drugs and monitor compliance
- Maintain contact with study subjects throughout study duration
7
Responsibilities For Senior Clinical Data Specialist Resume
- Perform other duti4es as assigned
- Assesses and documents subjects' response to treatment through physical assessment and or data analysis; reports any evidence of toxicity to drugs or chemicals used in treatment of subjects
- Identifies inclusion/exclusion criteria, reads medical charts and enters data on new subjects; if they meet registration requirements in research study, enrolls subjects and instructs them in protocol procedures
- Submits confidential records and research materials to study group reviewers at other institutions when applicable
- (c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or (d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records
- Clinical Research Life Cycle process knowledge in medical device and/or
8
Responsibilities For Clinical Data Specialist Supv Resume
- Intermediate to advanced level proficiency with relational databases (EDC) systems. Big-picture and detail-oriented view of data management processes, tools and procedures
- Assesses and documents subjects' response to treatment through physical assessment and/or data analysis
- Performs data collection activities for the North Texas Burn Rehabilitation Model System
- Consents patients for participation in the study
- Interviews patients in person and by phone
- Attends burn rounds, burn conference and burn clinic to help identify patients for the study and to collect data
- Assesses and documents subjects response to treatment through physical assessment and/or data analysis; reports any evidence of toxicity to drugs or chemicals used in treatment of subjects
9
Responsibilities For Clinical Data Specialist Resume
- Clinical Research Life Cycle process knowledge in medical device and/or pharmaceutical data management environment
- Big-picture and detail-oriented view of data management processes, tools, and procedures
- Knowledge of clinical terminology, regulations, GCP, GDP, GDMP, FDA 21 CFR Part 11 regulation, ICH, and HIPAA
- Computer proficiency in MS Office products (eg, Microsoft Project, Excel, MS Word)
- Performs post-discharge, pre-bill reviews of target case populations (low acuity deaths, long length of stay focus areas, sign & symptom principal diagnoses, HACs/PSIs, etc.) to verify that all significant secondary conditions are accurately reported. When appropriate, queries physicians for additional documentation or specificity to ensure completeness and accuracy of the medical record
- Operations Oversight Responsibilities: Develop plans and systems to oversee dosing protocol compliance, adverse event reporting, and data collection at 40-50 study sites. Direct and oversee the efforts of junior CRCs on the drafting and maintenance of study guidance documentation (e.g. MOPs, lab manual, data management plans, data system SOPs, etc.)
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