SUMMARY:

• Nearly 6 years of experience as Clinical Data manager in various reputed Contracting research Organizations (CROs) with hands on experience in Trial Start up, Conduct and Close out activities for Clinical trials and registry studies.
• Experienced in building the studies from the start - up.
• Competent in preparing e-Case Report Forms (eCRFs)
• Well versed in performing User Acceptance Testing (UAT) and data capture/entry screens.
• Extensively worked on developing the edit checks, various reconciliation specifications guidelines, eCRF filling guidelines and writing the test scenarios.
• Very well versed in performing data validation, process reviews, dataset reviews, maintaining various issue logs.
• Performed Query trend analysis.
• Well versed in performing QC.
• Experienced in handling data transfers and Post live changes.
• Presented Investigator meetings.
• Performed study close out activities.
• Maintained Trial Master File (TMF) / study documentation files.
• Efficient team player and multi-tasker with mentoring and supervising experience which includes maintaining coordination between cross-functional departments.

SKILLS:

Therapeutic Area Experience: Oncology, Cardiology, Gastro Intestinal Tract, Respiratory diseases, Dermatology and Medical devices.

CTMS Tool Experience: Hands on experience with CTMS Tools - RAVE, InForm, DataLabs, OC RDC, PheedIt, Clintrail, Oracle Clinical and proficient in BASE SAS.

Reporting Tools: I-review and J-review

EMPLOYMENT HISTORY:

Clinical Data Manager

Confidential, Atlanta

Responsibilities:

• Provide general oversight for data management activities performed as required to Sponsor to ensure quality for phase studies
• Review and manage key data management documents and specifications, including eCRF completion guidelines, dictionary coding specification, and data management plans
• Oversee eCRF and data validation specification development and manage internal, cross-functional review
• Perform user acceptance testing (UAT) of eCRF screens and programmed edit checks
• Perform periodic data and coding review to identify quality issues and general data trends
• Manage CRO timelines and coordinate cross-functional feedback to achieve timely delivery of data extracts in support of deliverables
• Liaise with laboratory and safety vendors to ensure appropriate data transfer agreements in place and for data transfers reconciliation between external and clinical databases
• Review study statement of work to ensure appropriate scope and cost based on study requirements

Clinical Data Manager

Confidential

Responsibilities:

• Effectively managed the team and also acted as Point of Contact between Onshore and Offshore teams.
• Plan, manage, control and performs data processing and management activities for assigned projects.
• Led assigned data processing and management projects. Managed timelines and coordinate activities for assigned projects.
• Specified database validation checks for assigned studies. Led efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules.
• Led efforts in building a standard query library for common database modules as well as for therapeutic/drug area specific modules.
• Validated and distributed study progress status reports to internal and external study team members.
• Cooperated and assisted, when required, data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema and databases for assigned studies.
• Effectively communicated project status and timelines with the project team, study lead, project lead, project manager and other cross functional groups.
• Prepared Sponsor metrics on a weekly basis.
• CTMS tools worked Inform, RAVE.

Clinical Data Manager

Confidential

Responsibilities:

• Wrote, read, implemented and assisted in training on clinical data management SOP's, templates and forms, (i.e. including but not limited to: data management plan SOP and template, data audit plan SOP and template, and edit specification plan and template)
• Created and maintained CDISC-CDASH-compliant metadata structure in all required dataset domains during CRF development and database design.
• Coordinated and worked with clinical programmer to ensure standard eCRF library is consistent with CDASH/ Standard Data tabulation Model (SDTM) metadata structure.
• Identified and assisted to implement and execute new clinical data management procedures with the clinical data management team to plan resources and timelines for projects.
• Presented Investigator meetings.
• Trained and supervised Data Entry personnel and junior data management personnel on study procedures, study specific handling and management of trial data.
• Defined and monitor clinical trial dataflow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines. Performed clinical trial site monitors' training on dataflow and quality control processes.
• Employed PheedIt to capture, review, clean, update, reconcile, and control quality of data in clinical databases.
• Interfaced with both internal and external study team on different study projects.
• Assisted with budgeting.
• Reviewed clinical study datasets and documentation for completeness, accuracy, and consistency.
• Performed review, editing and modification of clinical study data documentation and SOPs on Clinical data management processes.
• CTMS tools worked Inform, PheedIt, OC RDC.

Clinical Data Manager

Confidential

Responsibilities:

• Reviewed electronic edit check prior loading into clinical databases during database testing (UAT). Performed Data validation.
• Performed review of clinical events and medications coding, document tracking, and file maintenance.
• Interfaced with safety department representative for the review and reconciliation of safety data issues
• Performed review of clinical coding of all clinical trial adverse events and medications, and worked with clinical coders and statistician on coding based on MATCH and MISMATCH criteria.
• Provided feedback to project leads regarding project status, data quality, and any data issues.
• Effectively managed team.
• Identified and reported protocol violations and maintained Protocol Deviations tracker.
• CTMS tools worked RAVE, Inform and OC RDC.

Associate Clinical Data Manager

Confidential

Responsibilities:

• Performed discrepancy management.
• Involved in CRF designing, data validation, query management, safety data management to produce the desired AE/SAE report and managed the clinical data as per regulations.
• Trained in base SAS, pharmacovigilance and biostatistics.
• CTMS tools worked Oracle Clinica, Clintrail.

Trainee

Confidential

Responsibilities:

• Estimated the Quality of PAR-4 (Pharmaceutical Intermediate) at different production stages using H.P.L.C. and G.C.
• Learning how to investigate or report questionable test results.
• Learning how to interpret results, compare them to established specifications and control limits.