Clinical Data Manager Resume Samples

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Clinical Data Managers gather information from clinical trials and are responsbile for providing data collection options, validating data, transmitting data securely, sorting information, solving various operational problems and identifying inconsistencies. Successful resume samples for Clinical Data Managers showcase medical terminology knowledge, clinical trial experience, accuracy, attention to details, computer competencies, organizational skills, and good communication and presentation abilities. Educational requirements vary, and most candidates highlight a degree in life sciences and special certifications in their resumes.

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1

Clinical Data Manager

Responsible for creation of DMP (Data Management Plan) and Edit Checks Specifications, Edit Checks Testing and Validation for both Paper and EDC studies such as AGIIS (IVRS/IWRS), CAT, UAT and DTD Testing, Reports, Review and Validation. Data Cleaning/Discrepancy Management of paper-based and EDC projects according to the SOPs to ensure compliance with the study protocol. Support of the documentation, testing, implementation, validation, and utilization of systems used in Clinical Data Management activities.

  • Recognized by Senior Department Managers for superior performance and requested by name to support other departments with tight deadlines.
  • Received Award of Excellence for identifying critical discrepancies in the database that supported company's FDA submission for drug approval.
  • Key member of a data quality improvement team that reduced data errors by 70%.
  • Assigned by senior management to Project Initiation Group based on expertise in database design, report testing and database validation.
Candidate Info
23
years in
workforce
6
years
at this job
AA
Pre-dentistry
Ddm
2

Clinical Data Manager

Developed and updated Data Management documents (Data Management Plan, Data Validation Specifications, Data Entry Guidelines, CRF Completion Guidelines, Case Report Forms) while applying regulatory guidelines, standard operating procedures, and protocol requirements for 6 Phase I, on-going paper-based studies and 2 start-up studies on obesity and Type II Diabetes in Oracle-Clinical 4.5.3. Maintained study documents accordingly.

  • Assisted in updating Data Management Standard Operating Procedures (SOPs) as needed.
  • Trained Clinical Data Specialist on study-specific entry procedures(SSPs) for 6 on-going projects and 2 start-up studies; assisted in implementing plans for data processing within established time lines based on project needs.
  • Performed validation & assisted with database QC and all data cleaning activities for all on-going and start-up studies with little supervision.
  • Audited database of two studies nearing completion, documented findings, and generated error report.
  • Furnished feedback and/or possible data management solutions to Senior Clinical Data Manager, Project Managers & Director of Clinical Affairs regarding on-going studies.
Candidate Info
8
years in
workforce
3
years
at this job
BA
Biology
MS
Health Policy And Management
3

Clinical Data Manager I

Data management lead on 2 projects. Developed and implemented Data Management Plan, systems set-up, data accession, data entry and data review specifications and processes within timelines and budgets.

  • Managed clinical data vendors utilizing strategic communication skills that increased productivity, quality and punctual delivery of projects.
  • Developed and maintained close liaison with project client contacts, core team members and Project Managers.
  • Performed date review, validation, query development and resolution.
  • Implemented and maintained data auditing reports, metrics and tracking reports.
  • Reviewed and revised all documents for Trial Master File.
  • Conducted all database release activities.
  • Computer skills include Phase Forward, inform, Oracle Clinical, CIWS, I-review, ClinTrial, Dictionary Coding, QRMS, SQL, CRAMS, IDX, UNIX, Microsoft Office XP.
Candidate Info
16
years in
workforce
1
year
at this job
HS
High School Diploma
AS
Applied Science
4

Clinical Data Manager

Performed a variety of independent activities involved in organizing and conducting research
studies within the overall scope of research projects in cancers

  • Performed a variety of independent activities involved in the collection, analysis,
  • Collected appropriate data; collected and verified patient data of about 1300 patients;
  • Monitored patient progress to determine if individual patient endpoints such as:
  • Educated Clinical Research Associates about data submission schedules, form
  • Conducted Institutional Reviews and attendance of lectures/seminars on cancer
Candidate Info
5
years in
workforce
2
years
at this job
BA
Bachelor of Arts
MA
Master of Arts
Psychology
5

Senior Clinical Data Manager - Consultant

Performed data management (DM) activities for the assigned clinical trials studies ensuring (CDM) procedures and processes to meet business requirements. e.g. (Performed as a lead to two complex studies: CRF tracking, reviewing, query generation, eTract mapping, resolving data clarification forms (DCFs) and a direct contact person globally).

  • Archived and submitted relevant study documentation to the Document Records Center (IDRC) for indexing.
  • Generated and reviewed ad hoc listings, reports and quality control documentation to facilitate validation of the clinical database; Reviewing Study Definition Matrix (SDM), Data Validation Procedures (DVP), Data Management Plan (DMP) to ensure data consistency.
  • Performed assigned tasks independently and within timelines according to the CDM Project Plan, SOPs and Sponsor specific requirements.
  • Maintained study documentations for the project team. (E.g. archiving documentation in the Database Data Management System (DDMS), obtaining study required document signatures).
  • Interacted regularly w/ the DM team for newly assigned tasks & communicating with the assigned teams globally. e.g. (CFO's, CRA's, Monitors).
  • Coordinated weekly meetings of CDM Early Development Therapeutic area team.
Candidate Info
9
years in
workforce
2
years
at this job
BS
Biology
6

Team Lead - Senior Clinical Data Manager (contract)

Used InForm to clean hypertension study data in accordance with SOP's and the protocol.

  • Managed team of 5 on hypertension study. Conducted team meetings; managed weekly schedules and confirmed accuracy of timesheets
  • Handled data collection, ensuring accuracy and consistency of clinical data, and reviewing processes to ensure compliance with internal and external guidelines
  • Resolved data discrepancy and related issues by interacting directly with investigator sites
  • Authored data discrepancy and applied data changes resulting in resolved discrepancies
Candidate Info
2
months in
workforce
2
months
at this job
BA
Sociology
MA
Psychology
7

Clinical Data Manager

Performed data cleaning activities for Phase II & III global and domestic studies

  • Administered user database for an Inform (including LNMT) trial
  • Communicated study metrics to clients, vendors, and internal team members
  • Documented clinical data management processes and procedures
  • Reconciled discrepancies between CTMS and external data sources
  • Wrote Change Orders & UAT scripts for one EDC (InForm) trial, perform UAT for other studies
  • Studies are in the areas of Oncology, Renal and Hepatic
Candidate Info
15
years in
workforce
2
years
at this job
HS
Cra Professional Development Program
C
Practical Project Management
BA
Psychology
8

Sr. Clinical Data Manager/data Management

Data Management team leader of multiple projects (phase II, III and IV) for a global, full service Contract Research Organization. Implementation: Oracle Clinical Data Base Management System. Therapeutic areas: Hepatitis B, Acute Coronary Syndrome and Acute Myeloid Leukemia.

  • Liaison with clinical team and clients to effect successful project outcomes
  • Supervised and trained project personnel; organized and oversaw all quality control work done
  • Developed and maintained project files (including DM Plan, Edit Checks and Entry Guidelines)
  • Directed all DM activities and quality of work done; monitored actual time against contract time allocated
  • Hands on project work: discrepancy reconciliation and SAS datasets review plus Serious Adverse Event reconciliation
  • Received Spot Award in 2004 and an employee exemplification bonus in 2005
Candidate Info
9
years in
workforce
2
years
at this job
BS
Biology
9

Clinical Data Manager

Acted as a Lead Clinical Data Manager for one or more projects, provided support to the Lead Clinical Data Manager.

  • Worked on 2 phase 3 studies (endocrinology - diabetes)
  • Supervised a team of data entry operators and clinical data coordinators.
  • Liaised with clients and colleagues in other functional groups as required.
  • Projected delivery responsibility; meeting timelines and deliverables of the projects.
  • Prepared and maintained DMP (Data Management Plan) and project status reports.
  • Designed & prepared Case Report Forms (CRFs).
Candidate Info
9
years in
workforce
9
months
at this job
BS
Business Administration
BS
Computer Science
MA
Business Administration
10

Clinical Data Manager

Managed and analyzed clinical drug development data for Phase III global cardiovascular trials

  • Set-up. Audited and maintained data in INQUIRE Databases, on the IBM
  • Programmed in SAS, on the IBM 3090, under VM/CMS and MVS and on the HP 3000, under the MPE operating system
  • Prepared oral and written communications to clinical task force
  • Supervised and instructed data management specialist and data entry personnel
Candidate Info
34
years in
workforce
23
years
at this job
BS
Biology And Psychology
MS
Computer Science
Mis Program

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