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Sr. Clinical Data Manager Resume

SUMMARY

  • More than 7 years of extensive experience in the field of clinical data management
  • Excellent analytical and planning capabilities with commitment to achieve clinical data management objectives in timely manner
  • Clinical research professional with thorough knowledge in research study start - up, quality assurance, data review, data analysis, database clean-up and database finalization using clinical data management systems
  • Performed clinical tasks in the therapeutic areas including oncology, central nervous system and infectious diseases
  • Experience in clinical trial phases I-IV, from early phase development exploring safety and efficacy to late phase clinical development and post-marketing
  • Proficient in Paper&EDC trials
  • Strong and comprehensive CDM skills spanning from study start-up, study conduct, close out and Medical Coding activities
  • Extensive knowledge of CRF design, Edit checks creation, data cleaning and query process, Lab Data Reconciliation, SAE Reconciliation.
  • Expertise in CRF tracking, Database QC, Database Audit.
  • Experience in Oracle Clinical RDC, InForm, Rave, CRFTrack.
  • Excellent understanding of ICH GCP knowledge, GCDMP & 21 CFR Part 11
  • Experience in Vendor Management, Team management, Client Interaction and communicating with different departments within the clinical research domain.

TECHNICAL SKILLS

  • Data analysis eCRF design
  • UAT execution
  • Discrepancy management
  • SAE reconciliation
  • External vendor data reconciliation
  • Data locking
  • 21 CFR part 11
  • INFORM
  • Clintrial
  • CDISC
  • Medidata Rave
  • Oracle clinical
  • GCP
  • DCF (Data Clarification Form)
  • SEC (Self Evident Correction)

PROFESSIONAL EXPERIENCE

Confidential

Sr. Clinical Data Manager

Responsibilities:

  • Involved in writing and reviewing CRF completion guidelines
  • Review data management plans and data validation plans
  • Performed clinical trial data management activities for Phases I to IV
  • Participated in database designs and forms development
  • Reviewed and tested eCRF screen design and written data management plans for EDC and paper based trials
  • Involved in creating Edit check specification and performing UAT using Phase forward INFORM
  • Performed QC of data for several trials
  • Interacted with the sites and CRA to coordinate error resolution using data clarification forms
  • Worked with external CRO
  • Generated and resolved queries via Oracle Clinical and INFORM
  • Executed SAE reconciliation and external vendor data reconciliation for several clinical trials
  • Responsible for supporting database locking activities, including planning and executing listing reviews and identifying remaining clinical and monitoring tasks
  • Responsible for aiding in the closing of a database for a deliverable to the FDA
  • Ensured FDA regulatory standards compliance (particularly 21 CFR part 11), performing quality assurance on electronic data capture tools

Confidential

Clinical Data Manager

Responsibilities:

  • Vendor Management
  • Providing feedback to the clinical team on protocol and CRF design.
  • CRF designing
  • Developing of study documents like Data Validation Plan, CRF Filling Guidelines and Data Entry Guidelines etc.
  • UAT Testing: Testing and executing Validation procedures.
  • Generating queries to clarify and improve the quality of the data, resolve them or initiate their resolution either via research associate or directly with the investigational site.
  • Performing the database testing and database audit as part of Quality Control.
  • SAE Reconciliation
  • Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
  • Team Management: Ensure appropriate distribution of work among direct reports, supervise and co-ordinate all the data management activities for the studies assigned to the group. Daily monitoring of DM activities carried out by internal and FSP direct reports.
  • Contributed towards developing guidelines/checklist that aids in streamlining of activities for Data Management (DM) during study close-out.
  • Imparting training along with coaching and mentoring of new personnel in the organization.
  • Provide inputs to the Manager on resources, scheduling and timelines as required.
  • Client Interaction: Point of Contact of 3 studies for the client, giving study related presentations to the clients.
  • Contributed towards fine-tuning of standard DM processes, in collaboration with global colleagues. Identifying and implementation of best practices for DM.
  • Participated in company task forces and initiatives.
  • Liaised with monitor, database programming, medical coding and statistical programming teams to ensure smooth functioning of studies.

Confidential

Clinical Data Coordinator

Responsibilities:

  • Perform/review SAE reconciliation
  • Performed discrepancy management (both automatic and manual)
  • Review data through listings and autoqueries.
  • Creating edit check document for given protocol
  • Issued and resolved DCFs
  • GenerateDataClarification Forms (DCFs) ifdatais incomplete, unclear or discrepant according to the validation specifications of theDataManagement Plan (DMP).
  • Develop and test databases and edit specifications
  • Ensured the studies are conducted as per the protocol requirements, SOPs, ICH GCP and standard guidelines
  • Leadership role in a specific area or process on a large study with guidance
  • Serve in the role of back-up to a Data Operations Coordinator and Data Team Lead.
  • Providing feedback to programming team in regards to the programmed listings and edits
  • Map the data trends with respect to the site and provide them to Clinical team.
  • Singly handling the CSSRS data for 4 studies.
  • Responsible for cleaning the CM and CMRA data for extension studies.
  • Manual review of the CRF data and data-dump listing

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