Clinical Data Manager Resume Examples

clinical data manager

  • Project level coordination and day to day oversight of Data Management tasks.
  • Experienced in database set up, CRF design, and data cleaning to efficiently ensure high quality data
  • Managing vendors, and ensure appropriate resources are available to meet the demands of the assigned clinical trials
  • Managing CDM deliverables in coordination with internal and external cross functional teams.
  • Collaborate with Statistical Programming to create internal data quality checks in support of Data Management activities
  • Review clinical data on an ongoing basis to ensure quality data
  • Provide guidance to study teams and external vendors regarding the technical aspects of clinical database structure and programming

senior clinical data manager

  • Creation and review of key study documents – Data management plan, eCRF completion guidelines, Validation documents (BRD, validation plan, PQ Script, UAT and Val summary report), SAE Reconciliation plan.
  • Creation of external data transfer agreement and plan.
  • Led multiple studies as the key point of contact.
  • Timelines and deliverable management for multiple studies.
  • Led an automation project on safety reporting that help in real time reporting of the safety events efficiently to the PV database.
  • Manage relationship with customer.
  • Develop Data Management binder structure as per TMF standards for CDM.

clinical data manager

  • Develop study documents, draft master ICF, clinical protocol, feasibility questionnaires, case report forms and CRF completion guidelines.
  • Contribute to site activation process, Site/Investigator identification, evaluation and selection, tracking of study start-up metrics, and ensuring that study information are accurately reported within relevant systems.
  • Define and implement the data review plan for assigned trials, as appropriate, participating in data review activities to support blinded data review meetings (BDRMs) and database locks
  • Contribute to the global cross-functional clinical project team, participate and report study progress.

clinical data manager

  • Presenting the Clinical data according to the standards (CDSIC) mentioned by FDA. 
  • Produce analysis datasets, listings, tables, and figures for research projects, according to specifications, while maintaining documentation and complying with pre-defined project / study standards. 
  • Program, according to specifications, analysis datasets, listings, tables, and figures for research projects. 
  • Ensure that study documentation and specifications are consistent and comply with company standards by providing input into pooled datasets, data structures, and specifications of analysis datasets, listings, summaries, figures and tables for observational studies.
  • Maintain records for all assigned studies including archiving of data analysis and associated documentation.
  • Doing Interim analysis of Data using the SAS.
  • Database testing (Screen UAT).

clinical data manager

  • Perform trial level oversight controls as described in the oversight plan, Quality Control (QC) process and work instructions with minimal Data Delivery Lead (DDL) direction.
  • Review clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
  • Ensure real-time inspection readiness of all Data Delivery (DD) deliverables for the trial; Participate in Regulatory Agency and J&J internal audits as necessary.
  • Plan and track content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. 
  • Take leadership role with the assigned clinical working group(s) to ensure that DD and TA trial needs and deliverables are met.
  • Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
  • Identify and participate in process, system, and tool improvement initiatives within DD.

clinical data manager

  • Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
  • Co-ordinate the Standardization of UAT process for the internal teams.
  • Lead data manager for various studies (Phase II, PhaseIII, Phase IV and registry studies)
  • Risk based discrepancy management and reporting for registry studies.
  • A good knowledge on GCDMP and ICH GCP.
  • Database designer experience DataTrak and Viedoc 4.
  • Data management in Rave, Viedoc and Datatrak.