Clinical Data Manager Resume
Headline : Proven Project Manager, able to assume multiple responsibilities and remain productive within fast-paced environment. Experience interfacing with multiple databases and collecting/processing data.
Skills : SAS Programming, Spanish Language.
- Tasked by Senior Management to address over-budget projects, I was responsible for successfully recapturing uncharged Out of Scope works.
- Result in generating Change Orders ranging. Developed change orders and monitored project costs.
- Reviewed invoicing and completed project administrative tasks.
- Coordinated project work within the Clinical Technologies group, including large multiple project programs for customers and global projects.
- Served as primary customer contact to establish project deliverables, schedules, and tracking mechanisms.
- Monitored and coordinated tasks of project team members, and ensured that project milestones were met.
- Served as a business leader responsible for tracking and managing project financials for single service projects.
Clinical Data Manager III Resume
Summary : Highly motivated and qualified professional with over 10 years of experience in the health care and clinical research arenas, is seeking a career challenge in the pharmaceutical industry.
Skills : Databases, Edit checks writing.
- CRF data review, preparation for entry, query processing, discrepancy management, Adhoc reporting, listing generation.
- Develop study specific database requirements and edit check requirements.
- Work closely with clinical database programmers to provide specifications at the time of study database development.
- Create and maintain data management plans, Data Review guidelines and other study-specific work instructions or guidelines for multiple projects.
- Responsible for the design and development of Case Report Forms (CRF) in collaboration with CRAs or Clinical Project/Program Managers.
- Performs Remote Data Capture study user acceptance testing and database QC.
- Generate CRF completion guidelines, process flowcharts, Standard operating procedures (SOP), assist in work instructions and training guidelines, etc.
Clinical Data Manager I Resume
Objective : Responsible for collecting data from a variety of medical research projects, such as clinical and pharmaceutical trials. They work collaboratively to make sure data is collected, managed and reported clearly.
Skills : Coding, Auditing, Management.
- Conduct continuous data quality audits on the discharge data set elements included in a screening methodology to see if these data elements.
- Correct quarterly error and warning reports from HSCRC. Analyze and verify the unedited data codes report.
- Coordinate the quarterly submissions of Inpatient and Ambulatory Surgery data with the coding sections and the Computer Service Center.
- Assist in the design and analysis of individual data requests from Administration, Hospital Staff, and outside agencies.
- Assist with the coordination of audits conducted by consultants.
- Review and approve recommended changes; perform final data entry of changes.
- Assist Business Office personnel in the interpretation of ICD-9-CM coding and DRG assignment for pre-authorization and reimbursement purposes.
Sr. Clinical Data Manager Resume
Summary : Project Manager with extensive experience managing and delivering projects on time. Proficient in project management, data management, document management and data analysis.
Skills : Sharepoint, MS Project, MS Office, Visio, PowerPoint.
- Well versed in the execution of data management architectures, policies, practices, and procedures in order to manage the information lifecycle.
- Performed all Data Management activities from CRF design to database lock.
- Participated in vendor selection, site management/training, and quality assurance activities.
- Reviewed CRF completion guidelines, monitoring plans, and clinical monitoring reports for accuracy and completeness.
- Managed study timelines, budgets, metrics, and data review plans. Responsible for the integrity of all Investigator data.
- Produced, validated and compiled all Clinical Trial safety report tables across multiple protocols.
- Understanding of FDA, ICH and GCP guidelines and knowledge of regulatory requirements.
Clinical Data Manager II Resume
Headline : Experience in Clinical Data management in working on a variety of changing environments. Proficient in Paper & EDC trials Strong and comprehensive CDM skills spanning from study start-up.
Skills : Microsoft Office, Education.
- Identified discrepancies, queried sites, and followed to resolution.
- Interacted with external project team members to help with data collection and clean-up efforts.
- Provided support to research assistants and other research personnel at the sites pertaining to data collection.
- Assisted in the development of progress reports for studies. Assisted in the development and writing of departmental SOPs.
- Performed data-management training for the research staff, including preparing training materials.
- Maintained Protocol-Specific Binders; extensive knowledge of protocol-specific CRF and Completion Instructions.
- Participated in team meetings, Local and Lead Node, and data-management conference calls.
Jr. Clinical Data Manager Resume
Objective : Responsible Statistical Programmer proficient in SAS Programming and statistical analysis. Passionate and motivated, with a drive for excellence.
Skills : SAS, Clinical Data Management.
- Design and validate clinical databases including designing or testing logic checks.
- Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems.
- Develop project-specific data management plans that address areas such as data coding, reporting, or transfer, database locks, and workflow processes.
- Design forms for receiving, processing, or tracking data.
- Process clinical data including receipt, entry, verification, or filing of information.
- Develop technical specifications for data management programming and communicate needs to information technology staff.
- Prepare data analysis listings and activity, performance, or progress reports.
Clinical Data Manager/Analyst Resume
Headline : To obtain a position involving interpersonal communication, flawless precision, and rigorous multi-tasking to create innovative content.
Skills : Inventory Management, Protocol, Medical Writing.
- Performed the review of clinical data using SAS programming. Coordinate and participate in the data lock process.
- Responsible for ensuring data management documents are inspection ready.
- Track and address issues associated with data management metrics such as clinical report form and query backlogs.
- Assist in the design and development of clinical trial documents such as case report forms, case report form instructions, field edit descriptions, paper flow, and data validation plan.
- Provide a clean, locked, quality database on time and within budget.
- Participate in database audits, peer reviews, and database quality reviews.
- Create, run, and review data reports to ensure database consistency and quality.
Lead Clinical data manager Resume
Summary : Extensive experience in the field of clinical data management. Experience in Clinical trial phases I-IV, from early phase development exploring safety and efficacy to late phase clinical development.
Skills : SQL, SAS, and Share point, Website Design, Photoshop.
- Oversee all DM activities internally, coordinating with the CRO, external vendors.
- Generated the project-specific timelines, deliverables and attained with at most quality.
- Developed Data Management plan, Data transfer agreements, CRF Completion guidelines, and other DM specific documents.
- Worked as a primary person from CDM in the meetings with Clinical, Safety, and Biostatisticians.
- Involved in the training of the Internal team, CRA's, CRO and vendors based on the project requirements.
- Created annotated CRF's in compliance with CDASH standards. Performed clinical trial data management activities for Phases I to IV.
- Involved in creating a Data validation plan including edit checks and Manual listings.
Lead Clinical Data Manager Resume
Headline : An accomplished and dedicated Clinical Data Manager seeking an opportunity that will allow to apply extensive knowledge and experience while continuing to develop professional and managerial skills.
Skills : Communication Skills, MS-Office.
- Develop SOPs and Data Management Plans (DMP) for clinical studies.
- Ensure that all clinical data management activities are compliant with DMP, SOPs, CFR 21 Part 11, and ICH GCP.
- Represent Clinical Data Management (CDM) on core meetings.
- Collaborate with CROs, statisticians, Study Project Manager, Medical Officers, and DBAs to determine data management deliverables and timelines.
- Oversee all data management activities, including discrepancy management, SAE reconciliation, data cleaning, and data coding.
- Project lead in data freeze and database lock.
- Responsible for delegating responsibilities to subordinates.
Asst. Clinical Data Manager Resume
Objective : Progressive clinical data management experience. This includes 11 years as Lead Clinical Data Manager /Data Management Project Leader on multiple Phase I-IV studies.
Skills : Technical Skills, Data Entry.
- Representing WCT in all dealings with the Sponsor and vendors with respect to Data Management aspects of the project.
- Data Management presentations at Investigator Meetings and site call-in hours.
- ECRF demonstrations and training of in-house CRAs.
- Leading a global DM call for all external and internal study stakeholders.
- Providing ongoing support to the Clinical Operations group.
- Coordinating daily activities of the data management team.
- Managing data cleaning activities for the periodic DMC reviews.
Clinical Data Manager Resume
Headline : Strong background in Access, Excel, data/business analysis, technical requirements, reporting, and a liaison between departments. To learn and grow with a company while using experience.
Skills : Technical Skills, Hard Working.
- Responsible for imaging systems and data for osteoporosis and bone safety clinical trials.
- Coordinate and set up all sites at the study start-up.
- Create and validate protocol-specific databases and data transfers.
- Write study specific Data Management Plan and Data Transfer Specifications.
- Write Report Specifications, and validate all reporting modules.
- Contact study sites for query issues and/or resolutions as well as all other data issues.
- Perform data transfers and overall database management.