Clinical Data Manager Resume Sample
Ewell Effertz
8088 Savannah Estate,
Los Angeles,
CA
+1 (555) 673 0460
Work Experience
Clinical Data Manager
05/2018
-
PRESENT
Phoenix, AZ
- Advanced decision-making skills and ability to assimilate complex information to understand core issues, develop proposed solutions that align with VA’s methodologies and support long-term interests of the client
- Plans, manages, and requests resource as required for assigned studies
- Maintains a consistent, manageable workflow for Data Management project team by monitoring enrollment information and communicating with project team to actively influence data collection
- Ensure work carried out under the DM Alliance is in accordance with SOP’s and Working practices and agrees deviations to the DM Alliance service level agreements for the Franchise CSU/Disease Area
- Supports each clinical study team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines
- Leads development of Data Review and Oversight Plans; contributes to other key study level documents (e.g. protocols, SAPs)
- At least five years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
- Create and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms
Senior Clinical Data Manager
12/2012
-
01/2018
Detroit, MI
- Review Protocols to ensure database feasibility
- Develop/build, review, and maintain a clinical database and supporting specifications documentation
- Develop/build, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing)
- Develop data transfer agreements and specifications with various vendors
- Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation
- Perform all aspects of DM process as related to processing and QC of the data
- Clean data for study close out and perform all database lock procedures
Lead Clinical Data Manager
09/2006
-
06/2012
Houston, TX
- Manage reconciliation with any external data (e.g. SAE, lab)
- Monitor study status (e.g. enrollment, CRFs, etc.) and provide status reports to the team
- Use standard conventions, tools, references and process in support of the coding of medical terms
- Ensures all DM procedures executed with a high attention to detail, accuracy and timelines
- Represent the DM function on project teams
- Write and review DM SOPs in accordance with GCP and ICH guidelines, and develop associated training and competency testing
- Maintain CRFs database standards
- Work in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection
- Mentor junior level staff on database management tasks and processes
Education
Lawrence University
2000 - 2005
Bachelor's Degree in Computer Science
Professional Skills
- Demonstrated problem-solving skills. Self-motivated and able to work independently using strong organizational, project and time management skills
- Demonstrate team working skills and good collaborator skills
- Data management experience including prior SAS programming experience and/or supervisory experience/training
- Handle multiple tasks and to prioritize, strong organizational and presentation skills
- Demonstrated strong leadership and project management skills
- Highly detailed oriented with strong prioritization skills
- Strong organizational, planning and critical-thinking skills
How to write Clinical Data Manager Resume
Clinical Data Manager role is responsible for interpersonal, clinical, organizational, database, computer, technical, negotiation, development, leadership, electronic.
To write great resume for clinical data manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Data Manager Resume
The section contact information is important in your clinical data manager 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 Manager Resume
The section work experience is an essential part of your clinical data manager 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 manager 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 manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Data Manager resume experience can include:
- Excellent organizational skills, problem solving abilities, negotiation skills, time management skills and initiative
- Excellent written, verbal and organizational skills; work effectively as a team player
- Highly organized and detail-oriented with effective planning and strong verbal and written communication skills
- Effectively apply knowledge and skills in a highly organized fashion while adhering to required guidelines, SOPs and client expectations
- Able to demonstrate good project data management skills
- Outstanding organizational and time-management skills with ability to multitask and prioritize
Education on a Clinical Data Manager Resume
Make sure to make education a priority on your clinical data manager 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 manager 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 Manager Resume
When listing skills on your clinical data manager 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 manager skills:
- Excellent interpersonal communication and project coordination skills with demonstrated ability to effectively interface with internal and external customers
- Strong project management skills and internal and external negotiation skills are required
- Effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, GCP, SOPs and client expectations
- Demonstrate good organizational ability, communication and interpersonal skills
- Customer focused, excellent interpersonal skills and strong attention to detail
- Strong problem-solving skills with CDM process and experience on computer systems for Data Management
List of Typical Experience For a Clinical Data Manager Resume
1
Experience For Senior Clinical Data Manager Resume
- Good problem solving skills for developing creative solutions
- Strong written, verbal, analytical, interpersonal and time management skills
- Experience in developing database and validation requirements/ specifications 6-8 years of experience with Electronic Data Capture (EDC)
- Strong communication and partnership skills with clinical site personnel, Clinical Research Associates, Biostatistics and external tool vendors
- Possesses excellent interpersonal communication skills (written and verbal)
- Preferably experience in stakeholder management and presentation skills
- Excellent interpersonal and electronic interpersonal communication skills
- Proven organizational skills, flexibility, and attention to detail
- Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment
2
Experience For Principal Clinical Data Manager Resume
- Effective communication skills, ability to work independent, self motivated
- Excellent interpersonal and oral, written, and electronic interpersonal communication skills
- Database programming experience designing studies and data validation programming in Medidata Rave and to CDISC standards
- Effectively manages assigned projects by adhering to established timelines and deliverables
- SAS programming experience in SAS/BASE, SAS/CORE is highly desirable as is experience with relational databases, i.e., Oracle
- Demonstrated capability in relevant experience
- Demonstrate knowledge of Good Clinical Practices (GCP), and International Conference on Harmonisation (ICH)
- Effectively communicate and manage expectations with project teams and EDC tool vendors and handle timely change requests as needed
- Experienced and understands the practice of Software Development Life Cycle (SDLC) particularly in the validation and verification of software
3
Experience For Lead Clinical Data Manager Resume
- Validation and verification experience of EDC systems
- Advanced computer skills in Microsoft Word, Excel, PowerPoint, and Project
- Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment
- Leadership skills and a positive personality
- Working knowledge of effective clinical data management practices
- Experience with projecting budgets for proposed projects and making capabilities & bid defense presentations
- Perform data validation at various stages of data processing and report development to ensure complete and accurate data capture and reporting
- Detail oriented while maintaining work efficiency, able to prioritize activities across various assigned study tasks
- Experienced at data listing review and query management
4
Experience For Program Clinical Data Manager Resume
- Experience with programming in SAS
- Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle)
- Experience working with multidisciplinary and cross functional persons/teams from Technology, R&D, Medical Safety, Regulatory and Quality functions
- Experience with all aspects of DM including Database Build, Study Startup, Study Conduct and Database Closure activities
- Strong ability to foster open communication and practice active listening to encourage a collaborative team environment
- Demonstrates a solution oriented approach to problem solving and a "can do" attitude
- Develop and maintain good communications and working relationships with Data Management team
5
Experience For Associate Clinical Data Manager Resume
- Experience of working with cross-functional teams of diverse people
- Demonstrated decision making in time constrained and complex situations
- Work under pressure demonstrating agility through effective and innovative team leadership
- Knowledge of disease area. Demonstrates a current, in-depth understanding of the relevant medicine and associated therapy area
- Experience or knowledge building databases with Medidata or Medidata Rave would be highly desirable
6
Experience For Clinical Data Manager, / Ii-home Based Resume
- : Experience clinical trial environment and/or performing clinical data management
- Experience in SAS/R, Analytics, and roles using data and information to drive business and product strategy
- Demonstrate a constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events
- Data and or abstracting experience required
- Experience in therapeutic area, phase I to Ill Clinical Trials, and managing complex study data
7
Experience For Clinical Data Manager, Scharp Resume
- Strong understanding of national and international (ISO, FDA & ICH) regulations in data management for clinical research
- Experience writing data management tool specifications
- Establish and maintain good working relationships with the different functional areas and work cross functionally as part of a team
- Knowledge of The Good Clinical Data Management Practices (GCDMP) and Food and Drug Administration (FDA) medical device regulations and guidelines
- Relevant experience in the biotech / pharmaceutical industry
8
Experience For Assistant Clinical Data Manager Resume
- Ensures data management staff provides excellent customer service both internally and externally. Manages conflict with customers to ensure positive outcomes
- Strong and positive work ethic
- Follow and ensure compliance with current Good Clinical Practices (cGCPs)
- BS/MS and/or relevant industry experience
- Experience in Clinical Data Management or equivalent
- Design paper and electronic data collection forms for data acquisition, and edit checks for data validation
9
Experience For Expert Clinical Data Manager Resume
- Experience in CRO and vendor management required
- Embracing and contributing to our culture of process improvements with a focus on streamlining
- Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE
- Training of global customers and cross-functional internal training as related to clinical registry
- Understanding of Clinical Data Interchange Standards Consortium (CDISC) and SAS® terminology
10
Experience For Clinical Data Manager, Work From Home Resume
- Generating data queries in the database Resolution of data queries
- Training in GCP, GMP and pertinent sections of FDA Code of Federal Regulations (e.g. CFR 21 part 11) is required
- Ensuring the integrity of clinical trial databases
- Understanding of local regulatory environment and commercial needs at applicable country levels relevant to assigned studies and projects
- Understanding and compliance with ICH GCP, and applicable policies and SOPs
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical and biotechnological companies
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical I biotechnological
- Training of data management staff
List of Typical Skills For a Clinical Data Manager Resume
1
Skills For Senior Clinical Data Manager Resume
- Skills in prioritization, problem solving, organization, decision-making, time management and planning
- Strong organizational, planning, and critical-thinking skills
- Strong ability to work in a matrix environment and communicate effectively with different functional groups across the organization
- Demonstrated organizational and time management skills, ability to meet deadlines
- Demonstrated ability to effectively develop and manage relationships with internal and external stake holders
- Strong interpersonal / communication (verbal and written) / presentation skills
2
Skills For Principal Clinical Data Manager Resume
- Demonstrated staff leadership skills
- Three years of applicable experience with demonstration of superior organizational and time management skills within a clinical or data management setting
- Excellent leadership, interpersonal and oral, written, and electronic interpersonal communication skills
- Excellent written and oral communication skills required. Occasional travel
- Demonstrated strengths in planning, organizational, analytical skills, time management, conflict management, problem solving, and attention to detail
- Able to effectively manage multiple projects and adapt flexibly to changing priorities
- Able to effectively manage multiple assignments and adapt flexibly to changing priorities
- Demonstrable planning, organizing and problem solving skills
- Electronic Data Capture (EDC) system experience including testing and validation
3
Skills For Lead Clinical Data Manager Resume
- Proven experience providing project and data management support on FDA regulated studies, complex multi-site studies or data coordinating center projects
- Exceptional organizational, problem - solving and negotiating skills
- Experience in Data Management with experience in managing projects and project teams
- Strong experience working independently and on cross-functional teams
- Proficiency in computer skills (i.e., data entry and word processing) is required
- Well-polished, inclusive, and engaging communication skills, both written and verbal
- Strong knowledge of and experience building complex data queries in COGNOS
4
Skills For Program Clinical Data Manager Resume
- Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
- Proven Leadership experience, managing a project or a team
- Four years of combined early or late stage Data Management experience with one year of direct sponsor management and one year technical mentoring experience
- Demonstrated strong knowledge in medical terminology, clinical study protocol, clinical trial process and therapeutic areas
- Highly developed leadership skills to successfully lead the Clinical Trial Team through data management activities
- Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve
- Demonstrate competence through significant experience in their degreed discipline
- Make effective decisions and manage multiple priorities in a highly dynamic environment
5
Skills For Associate Clinical Data Manager Resume
- Six (6) years of progressively responsible Clinical or Data Management experience, with at least four (4) years of Data Management experience
- Data management experience, additional experience(5+) required for CDM II and 8+ for PCDM Level
- Capable of interacting effectively with scientists and managers within and outside CSO TO
- Demonstrated managerial and interpersonal skill
- Relevant Data Management experience with direct sponsor management and one year technical supervisory experience
6
Skills For Clinical Data Manager, / Ii-home Based Resume
- Clinical Data Management experience in clinical research industry (sponsor/CRO/biotech or combo) or other relevant experience
- Demonstrate time management skill and ability to adhere to project productivity metrics and timelines
- Prior people management and clinical data management experience required
- Experience the development of data validation tools
- Effectively manage assigned protocol/study, establish timelines and milestones, monitor and communicate ongoing status and progress
- Experience with clinical data management systems, proficiency in EDC/RDC (e.g. RAVE, Inform, Oracle Clinical), experience in basic SAS / SQL programming
- Experience working under Good Clinical Practices and other Federal Drug Act guidelines
- Demonstrated skill for technical management of staff exceeding 10 employees
7
Skills For Clinical Data Manager, Scharp Resume
- Assist in database upgrades/migrations including performing QC of CRO User Acceptance Tests Skills/Knowledge Required
- Testing and validating study specific Electronic Data Capture System (EDC)
- Defining necessary validations or reports to ensure quality and timeliness of data collection
- Supporting the GMS Rockville analytical instrument validation program to assure compliance with GQMS and AEQMS
- Perform eCRF data validation to ensure data integrity and quality including raising and resolving data queries
- Experience using Statistical Analysis Software (SAS) programming and Risk Management Tools, including data review in JReview
- Experience with data management budgeting, forecasting and reporting
- Experience in managing and leading international meetings (Data Review, etc)
8
Skills For Assistant Clinical Data Manager Resume
- Strong knowledge of global standards related to clinical data management activities (data standards, database design, coding and coding dictionaries, etc.)
- Experience in managing outsourced studies or working for a CRO. -
- Experience in Clinical Data Management Process Development (drafting/ reviewing CDM related SOPs and WIs)
- Clinical Data Management System experience and understanding of database/programming concepts
- Experience of representing Data Management in bid defence meetings, providing innovative solutions to meet client needs
- Strong understanding of Basic, SAS, SQL and/or other clinical programming
- Demonstrated competency in accurate work with clinical trial or regulatory data, data mgt., programming, scripting or data operations
- Proven ability to exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining results and improve processes
- Software engineering experience (especially object-oriented code, unit tests, version control)
9
Skills For Expert Clinical Data Manager Resume
- Experience in all phases of data cleaning process throughout the life cycle of a study
- Load, validate and reconcile vendor data including scans and biomarker data
- Some experience in supporting Oncology studies
- Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are desirable
- 2) Lead the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines
- 3) Employ standardized electronic and ad hoc reporting tools to review clinical data for consistency with the protocol requirements and good clinical practices
- Experienced in understanding Sponsor responsibilities of oversight of a CRO
- Taff mentoring and leadership experience
- Related data management experience within the biotechnology/pharmaceutical industry or in a CRO setting
10
Skills For Clinical Data Manager, Work From Home Resume
- Experience in field reporting, systems support, or related areas
- Experience working as a data manager for clinical trials
- ) or equivalent combination of education, training, & experience
- SAS or SQL programming experience
- Data and/or abstracting experience required
- Experience in scientific assay data handling
- Experience managing biorepository data in a clinical/diagnostic laboratory or pharmaceutical/biotechnology R&D environment
- Previous experience of handling customer negotiations, eg bid defense meetings
- Experiences as a data manager in oncology therapeutic area, preferably 5+ years working in a clinical research environment
List of Typical Responsibilities For a Clinical Data Manager Resume
1
Responsibilities For Senior Clinical Data Manager Resume
- Excellent project management, organizational, prioritization, and multitasking skills. Demonstrated ability to work independently
- Exemplify, deliver and expect professionalism using strong interpersonal and organizational skills
- Strong communication skills with the ability to simply summarize complex information
- Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively
- Effectively partner with ESPs
- Carrying out Clinical Data Management UAT prior to release to the customer
- Knowledge in and experience with any of the following: Data review in JReview, Risk Management Tools, Statistical Analysis Software (SAS) programming
2
Responsibilities For Principal Clinical Data Manager Resume
- Manage database build activities, database validation and review and execution of User Acceptance Testing of clinical databases
- Good working knowledge of CDISC-SDTM, ODM, CDASH guidelines
- Experience with reviewing SAS datasets
- Highly desirable: experience supervising high complexity clinical pathology laboratories
- Experience working across multiple studies/projects across clinical areas simultaneously
- Anticipates changing priorities and demands and addresses them proactively
- Experience with Electronic Data Capture (EDC) systems
3
Responsibilities For Lead Clinical Data Manager Resume
- Clinical Data Management experience in the pharmaceutical or biotechnology industry
- No leadership experience required
- Experiences with Electronic Data Capture (EDC) processes
- Technical expertise including: industry data structure knowledge (e.g. CDASH/CDISC); EDC use and database specification experience
- Experience with data visualization/reporting, analytics; i.e. able to interpret integrated data displays and metrics identify and communicate trends
- Participating in training and coaching new hires on departmental processes and tasks
4
Responsibilities For Program Clinical Data Manager Resume
- Participating in designing and creating new tools to help improve the department processes
- Attending and participating in client meetings as requested
- Overseeing and conducting manual data review for Clinical Data Management customers
- Developing or guiding development of project specific documentation
- Overseeing all data management deliverables for assigned studies
- Ensuring that study database is appropriately cleaned in accordance with agreed upon data management plan
5
Responsibilities For Associate Clinical Data Manager Resume
- Managing Clinical Data Reviewers and Clinical Data Leads for each assigned Clinical Data Management project
- Providing management and customers with monthly project metrics and project status
- Ensuring compliance with and completion of deliverables as specified within the Data Integrity Plan
- Ensuring analytical instruments are maintained in a qualified state
- Participating in assigned departmental initiatives, including SOP development
- Performing all data management deliverables for assigned studies
- Adhering to all Bioclinica Clinical Data Management (CDM) procedures, policies, and work instruction
- Serving as the Study DM for studies across the complexity spectrum
6
Responsibilities For Clinical Data Manager, / Ii-home Based Resume
- Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making
- 10%: Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making
- Perform analysis of test transfers to determine coding specifications including any data translation and mapping needs
- Assist in the preparation and review of specifications for designing, monitoring and transferring of electronic databases
- Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers
- Assist manager in monitoring timelines and managing resources to meet timelines
- Oversee eCRF unit testing and database user acceptance testing
- Work with the Global Medical Director and project team in designing and developing Case Report Forms (CRFs)
7
Responsibilities For Clinical Data Manager, Scharp Resume
- Responsible for serving as clinical trial leader for a large-scale multi-country trial (Phase IV or Post Marketing)
- Attend relevant off-site meetings including training symposia, scientific meetings, etc. on an as-needed basis
- Assist in the development and implementation of the design and programming of clinical databases and data cleaning procedure
- Assist in database upgrades/migrations including performing QC of CRO User Acceptance Tests
- Ensures Data Management CROs are delivering quality data and documentation on time, on budget and to Shire’s quality standards and SOPs
8
Responsibilities For Assistant Clinical Data Manager Resume
- Investigate, evaluate and propose the use of emerging technologies (e.g., electronic data capture) in clinical data management
- With oversight, provides point of contact for site questions relating to study conduct issues
- Authors final reports summarizing execution of analytical instrument qualification protocols
- Assist CRO(s) with cleaning data for Interim Analysis, Database lock, and any add hoc requests
- Develop and deliver (technical) training
- Reviews all SOPS and completes relevant P2L training as required
9
Responsibilities For Expert Clinical Data Manager Resume
- Coordinate and/or perform UAT testing
- Ensure appropriate support and training are provided to designated staff per assigned project
- Lead and support initiatives for the development of new systems and process improvement initiatives, organizational SOPs, working practice guidance documents
- Define data mapping required to successfully import data
- Create standard data transfer format(s) in compliance with client requests while adhering to internal processes
- Manage design and development of eCRFs, including full UAT
- Serves as data management lead interacting directly with sponsor, sites and vendors on complex paper-based or EDC projects under minimal supervision
10
Responsibilities For Clinical Data Manager, Work From Home Resume
- Perform user acceptance testing on database applications and data transfers
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines and regulatory agency guidelines
- Generate and review reports and listings to maintain data integrity and reporting
- Courage to challenge: Takes risks and challenges norms to support tomorrow’s needs
- Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines. Consults with the team(s) to ensure the teams’ long-term needs are addressed
- Supports each clinical study team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines. Consults with the team(s) to ensure the teams’ long-term needs are addressed
- 10%: Courage to challenge: Takes risks and challenges norms to support tomorrow’s needs
- Review and approve study startup documents, Data Management Plan (DMP), Reconciliation Plan, Quality Control Plan, Coding Plan, Validation Plan, Communication Plan and other documentation as required
- Facilitate internal study team, client and CRO meetings
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