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