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CDM Sample Resume 1

This document summarizes the experience and qualifications of a Senior Clinical Data Manager. It outlines over 7 years of experience in clinical data management across various clinical trial phases. Key responsibilities included developing data management plans, designing case report forms, performing data quality checks, ensuring regulatory compliance, and managing vendor relationships and teams. Proficient with various clinical databases and data standards. Educational background includes an MBA and clinical data management certification.

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Rahul S
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423 views4 pages

CDM Sample Resume 1

This document summarizes the experience and qualifications of a Senior Clinical Data Manager. It outlines over 7 years of experience in clinical data management across various clinical trial phases. Key responsibilities included developing data management plans, designing case report forms, performing data quality checks, ensuring regulatory compliance, and managing vendor relationships and teams. Proficient with various clinical databases and data standards. Educational background includes an MBA and clinical data management certification.

Uploaded by

Rahul S
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Senior Clinical Data Manager

Name
@gmail.com
000-000-0000

SUMMARY

 Having 7+ years of experience in the clinical data management by working on a


variety of studies and phase (Phase I, II and III) of clinical trials
 Outstanding ability to plan, analyze and accomplish the CDM objective in a timely
manner.
 Proficient in paper and EDC trials.
 Strong and comprehensive CDM skills spanning from study startup, study conduct,
closeout, and medical coding activities.
 Proficient in e-CRF design specification, Edit check creation, data cleaning and
query process, SAE reconciliation and lab data reconciliation.
 Efficient experience in managing CRO’s work, study start up, study conduct, and
study close out activities of clinical trials to deliver clean and quality data.
 Excellent experience in working with CRO- oversight/ vendors to ensure smooth
study set up and smooth study conduct, close-out, reviewing the performance,
protocol deviation and maintaining awareness of issues raised.
 Experience in working with various EDC databases like Oracle Clinical, Inform,
Medidata Rave.
 Excellent knowledge of ICH, GCP, and US FDA safety reporting and guidelines and CDM
standards like CDISC, CDASH & 21 CFR Part 11.
 Developed Case Report Forms (CRF’s), Data management plans (DMP’s), User
Acceptance testing (UAT) for multiple clinical projects in accordance to protocol
specifications
 Expertise in CRF tracking, database QC and database audit.
 Experience in working with EDC databases like oracle clinical RDC, inform and
Medidata Rave.
 Therapeutic experience in Cardiovascular disease, Respiratory disease,
Oncology, Parkinson’s Disease, Rheumatoid Arthritis
 Expertise in working with vendor management, team management and client
interaction and communicating with various other departments within the clinical
research domain.
 Good interpersonal and communication skills.

EDUCATION

MBA
Certification
Bachelor’s
SKILLS
Database / EDC Systems Oracle Clinical, Medidata Rave, inform.
Operating Systems MS Office Word, Excel, PowerPoint, Access, Outlook.
Programming SQL, SAS, SPSS, Python.
Activities Query Management, Data Entry, and Data Analysis;
Database testing, CRF &DC tracking & reports, CCI/CCG,
UAT, Quality Control and locking databases.
Guidelines CDISC/CDASH, SDTM, MedDRA, WHODD, GCP/ICH
and 21 CFR part 11.

EXPERIENCE

Confidential MMM YYYY - Present


Sr. Clinical Data Manager

 Reviewed clinical research study protocols.


 Participated as data management representative at study meetings.
 Developed and maintained project documents like DMP, Data validation documents,
CRF completion guidelines and Data transfer agreements.
 Created annotate CRF’s based on the protocol specifics.
 Knowledge of clinical study setup process and randomizations.
 Performed clinical trial data management activities for phases (1 to 4).
 Involved in the trainings of internal team, CRA’S and CRO and vendors based on
the project requirements.
 Participated in study setup, validation, and implementation of clinical databases.
 Involved in creating edit check specification and performing UAT on different
Medidata rave bases.
 Reviewed clinical trial and Medidata rave data to ensure data integrity, consistency,
and accuracy throughout the study.
 Assist in the development of Vaccines clinical-specific guidance documents.
 Performed and reviewed reports for SAE, Lab reconciliation.
 Reviewed query status reports and coordinated with different departments for
unresolved queries. Testing for Oncology studies.
 Responsible for the day-to-day maintenance of the application systems in operation,
including tasks related to identifying and troubleshooting application issues.
 Performed QC of data for several trails.
 Created SQL queries for cleaning and analysis of clinical data.
 Authored data management documents- Data management plan, CCG, DTA.

2
Confidential MMM YYYY - MMM YYYY
Sr. Clinical Data Manager

 Responsible for maintaining the global library and implementation of


CDISC/SDTM/CDASH standards to study objects.
 Involved in writing and execute test scripts for database user acceptance testing.
 Performed documentation and archival as per Trail Master file (TMF) and supported
implementation of SOP’s.
 Client relationship management in partnership with infrastructure service support
team members.
 PK/PD data/ external data reconciliations and report creation using e-clinical smart
reporter of SAS Analytics.
 Responsible for timely initiation and completion of data management activities for
ongoing studies.
 Participated in developing CRFs and CRF completion guidelines.
 Ensure the completeness and validity of clinical trial Medidata Rave entered the
database & provide delivery of clean data for analysis and review by client/
regulatory bodies.
 If applicable helps to maintain consistency between MDR and rave libraries and
other standards.
 Created and met project specific timelines an performed the out of range checks for
lab data.
 Assisted in study setup, validation, and implementation of clinical databases
 Identified, developed, and raised queries in clinical databases.
 Conducted quality control of data for several clinical trials.
 Reviewed and developed data management plans for EDC and paper-based trails.
 Coordinates the quality control review of Medidata rave prior to database lock.
 Assisted with entering patient data into EDC database, answer queries and work
with other monitors to resolve issues.
 Communicated with monitor, database programming, medical coding, and statistical
programming teams to ensure smooth functioning of studies.

Confidential MMM YYYY - MMM YYYY


Clinical Data Manager

 Discuss study protocols with patients and verify the informed consent
documentation. 
 Provide patient with written communication of their participation (i.e. copy of the
signed informed consent).
 Assist the Investigator in Screening patients, study document preparation,
counselling the patients, dispensing the prescribed medicine, as per protocol.
 Schedule all patient research visits and maintain accessibility to discuss any
questions/concerns regarding the study.
 Collect data as required by the protocol.  Update CRF form. Maintains study
timelines.
 Record adverse event, side effect data, serious adverse events discuss with
investigators and report the events. 

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 Designed essential clinical documents (ICF, protocols, CRF, study reports)
 Entered the data in the clinical database using 1st and 2nd pass data entry.
 Supported in the role of back up for data team lead in managing the day today CDM
operations.
 Experienced in coding of medical terms and drugs in dictionaries like Med DRA,
WHO drugs in OC TMS.
 Performed, reviewed SAE reconciliation, lab reconciliation.

Confidential MMM YYYY - MMM YYYY


Clinical Data Manager

 Performed the review of clinical data using SAS programming. Coordinate and
participate in the data lock process.
 Data Management experience on multiple projects simultaneously in various Phases
and therapeutic areas of clinical trials including Oncology, Respiratory and
Cardiology.
 Conducted Snapshot/interim analysis (J review) to check study accuracy and
reliability through data cut points.
 Responsible for ensuring data management documents are inspection ready.
 Tracked and addressed issues associated with data management metrics such as
clinical report form and query backlogs.
 Assisted in the design and development of clinical trial documents such as case
report forms, case report from instructions, field edit descriptions, paper flow, and
data validation plan.
 Provided a clean, locked, quality database on time and within budget.
 Participated in database audits, peer reviews, and database quality reviews.
 Created, ran, and reviewed data reports to ensure database consistency and quality.
 Prepared case report forms according to data entry guidelines.
 Maintained timeframe logic statements and ensured accuracy in databases.
 Performed review on all data capture systems.

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