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CDM Sample Resume 2

This clinical data manager has over 8 years of experience developing case report forms, data management plans, and user acceptance testing for clinical projects. They are proficient in clinical data management according to GCP, ICH, FDA, and CDISC standards. Their experience includes activities such as data validation, discrepancy management, coding, safety reporting, and laboratory data reconciliation. They have worked with multiple CROs and databases such as Oracle Clinical RDC and Phase Forward Inform.

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Rahul S
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77 views4 pages

CDM Sample Resume 2

This clinical data manager has over 8 years of experience developing case report forms, data management plans, and user acceptance testing for clinical projects. They are proficient in clinical data management according to GCP, ICH, FDA, and CDISC standards. Their experience includes activities such as data validation, discrepancy management, coding, safety reporting, and laboratory data reconciliation. They have worked with multiple CROs and databases such as Oracle Clinical RDC and Phase Forward Inform.

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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SR CLINICAL DATA MANAGER

NAME
Email : @gmail.com
Phone: 000-000-0000
_____________________________________________________________________________________

PROFESSIONAL SUMMARY
Diligent professional with 8+ years of experience in Clinical Data Manager adept at managing
databases and ensuring proper collection of key information. Proficient who has been recognized
for superior communication, technical, and analytical skills. Resourceful, tenacious problem
solver with proven ability to bring quick, innovative resolution to challenges.

 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 working with study start-up, conduct and close-out activities.
 Detailed Knowledge and data management experience in accordance with GCP, ICH
guidelines and FDA regulations and CDM standards like CDISH, CDASH & 21 CFR
Part 11.
 Extensive knowledge on study start-up activities like SDR, DVS, UAT and coauthored
DMP, DTA and CCG, Data Handling Plan (DHP) and Data Review Plan (DRP).
 Worked on study conduct activities like Data Validation, Discrepancy management,
Coding, SAE reconciliation and Lab reconciliation.
 Served as a Subject Matter Expert for data management activities for different studies.
 Worked closely with multiple CRO’s and conducted monthly data review meeting to
lead the projects.
 Developed Pre-locking Checklist for database Review and Lock.
 Overseas and/or provides technical support to Data management and /or CRO.
 Expertise in working with EDC databases like Oracle Clinical RDC, Phase Forward
Inform and Mediate Rave.
 Efficient under tight timelines and strict deliverables, ability to resolve issues and meet
deadlines.
 Therapeutic experience in Cardiovascular diseases, Respiratory disease, Oncology,
Parkinson’s Disease, Rheumatoid Arthritis.

EDUCATION
 Bachelor’s in Computer Science
PROFESSIONAL EXPERIENCE
Sr. Clinical Data Manager
Confidential Date

Responsibilities:
 Participated in review of clinical protocols and amendments to coordinate the design and
testing of data capture systems.
 Tracked data queries to ensure the integrity of the clinical data with respect to data
guidelines and protocol specifications.
 Collaborated with the Clinical Data Scientist, ensured operational excellence across all
deliverables.
 Reviewed creation and maintenance of all essential data management documentation
including CRF specifications, eCRF, annotated eCRF, eCRF completion guidelines,
Data Management Plans (detailing complete data management processes throughout
clinical studies), Data Transfer specifications and Data Review Guidelines, in
accordance with the protocol.
 Managed data management projects provided leadership to the corresponding data
management teams.
 Represented the company in all dealings with Sponsors with respect to the Data
Management aspects of the projects.
 Reviewed electronically processed medical records received from sites, external third-
party datasets, and other healthcare related data.
 Responsible for timely and high-quality data management deliverables. Established asset
and study level strategies and services, including excellence in the application of
standards.
 Reviewed query status reports and coordinated with different departments for
unresolved queries.
 Coordinated in completion of various duties, including data transfers and quality reviews
of the database, database lock and release, archival of data management documentation
and files and coordination of coding for the adverse event and medication.
 Liaise with Biostatisticians regarding data validation and lock of the database, including
management of discrepancies.

Sr. Clinical Data Manager


Confidential Date
Responsibilities:
 Created and reviewed project specific documentation Data Management Plan (DMP)
and the Data Management File for trials.
 Ensured launch, delivery, and completion of all Data Management Activities according to
contractual agreement and relevant Stand Operating Procedures (SOPs)
 Monitored and communicated project progress to the Sponsor and project team including
use of project status reports and tracking tools/metrics to enable in stream data collection
and query management.
 Performed verification and User Acceptance Testing of configured databases.
 Worked on specifications for the set-up and modification of database and Edit Check
Specifications.
 Responsible for all phases, including preparation, set-up, initiation, conduct, database
lock.
 Design and review CRF’s design according to the final protocol to ensure consistency.
 Worked extensively with CRO’s during study conduct on Cleaning the data,
Discrepancy management, Lab Reconciliation and SAE Reconciliation and study closing
activities including Data Review, Data freezing and Study Lock for Oncology,
Cardiovascular etc.
 Performed database locking activities to ensure data accuracy.
 Coordinated all activities of Data Management operations, manage project timelines and
resource plans across all projects to meet project milestones and ensuring high quality on
every deliverable.
 Handled communication and interactions between CRO’s and vendors (local or central
labs) for collection, transfer of the study specific data collections.

Sr. Clinical Data Manager


Confidential Date
Responsibilities:
 Developed and maintained project plans, specifications, and documentation in line with
SOP requirements.
 Responsible for Reconciliation and performed reconciliation of data from external
sources e.g., Serious Adverse Events, IVRS, Central Laboratory.
 Assisted in developing data management plan, data transfer agreements.
 Performed UAT testing to validate the database by using the test scripts.
 Served as a primary point of contact for sponsor, vendors, clinical operations team,
database programmers, medical monitor, and SAS programmers for the execution of
CDM deliverables.
 Work with team members via matrix relationships (internally or at CROs) by directing
work, resolving problems, or providing guidance.
 Lead the team to meet timelines by going split live to facilitate protocol design and
amendments.
 Support the study set up, conduct, close out (data base lock) as per quality timelines.
 Performed data review for SAE reconciliation, Lab reconciliation and Discrepancy
management periodically.
 Tracked study progress and insisted associates and coordinator for data precision.
 Accomplished quality control measures which are mandatory for the freezing and
locking of the database.
Clinical Data Coordinator
Confidential Date
Responsibilities:
 Collaborated with CRO, External Vendors for internal and external data management
activities.
 Identified and resolved data management issues, in coordination with other departments
and contract data management groups, as appropriate.
 Responsible for discrepancy management, SAE reconciliation, and Lab reconciliation
 Perform checks on the clinical data in accordance with the study specific guidelines to
ensure its validity.
 Reviewed the protocols and created CRF specifications, eCRF, eCRF completion
guidelines, Data Management Plans
 Performed UAT testing to ensure the database is defect free.
 Created test cases to validate the database for correct Edits Check.
 Collaborates with CRO and study team members to identify and resolve issues impacting
goal attainment.
 Supported clinical trials for Contract Research Organizations by providing accurate data.
 Strategized standard process for data collection, data entry, integration, monitoring,
review (edit check specifications), and reporting to align with regulatory compliance.
 Provide input into the development of data management SOPs and processes. Write or
review Data Management work instructions and SOPs.

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