Manager Data

Rama Yelekar

Clinical Data Manager

Summary:

• More than 2.5 years of experience in Clinical data management involving reviewing the

inconsistent clinical data, querying sites and updating database.

• Involved in performing SAE reconciliation, external lab reconciliation and query

management and in all data management activities i.e. UAT testing.

• Ability to work independently as well as in a team environment.

• Thorough understating of Clinical Research process, FDA regulations, MedDRA, Medidata

Rave & Oracle clinical RDC.

• Good understanding of GCP, ICH and 21 CRF PART 11 regulations.

• Excellent Information Technology skills (MS Word, MS Excel, MS PowerPoint, MS

Access, MS Outlook, Windows XP, Windows Vista, Windows 7).

• Strong presentation and communication skills.

PROFESSIONAL EXPERIENCE:

Novartis, Florham Park, NJ

Clinical Data Manager II - Oncology Aug 2010 – till date

Duties and Responsibilities:

• Provide professional Data Management input on Clinical Trial Team.

• Input to and review of clinical trial database design including User Acceptance

Testing (UAT).

• Perform User Acceptance Testing of databases and procedures and produce mock data for

testing.

• Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical

trial, which includes participate in the meeting, writing the study specific validation

checks and necessary reports to ensure high quality and consistent data.

• Identify errors/inconsistencies and resolve them or initiate their resolution to ensure high

quality and timely database locks.

• Produce summaries and listings of safety and efficacy data in I-review and J-review.

• Support Assistant Data Managers and other Data Managers for allocated trials.

• Generate open queries reports and summary in oracle clinical database for CRA and site

review.

• Perform data management activities for assigned clinical trials including SAE

reconciliation.

• Review Case Report Forms (CRFs).

• Participate in development and review of policies, SOPs and associated documents for

CDM.

• Assign tasks of providing study specific instructions to investigators and external parties.

• Participate in freezing and locking the data as appropriate in time for statistical review,

interim and final database lock.

Clininvent Research, Andheri (E), Mumbai

Clinical Data Manager – Oncology Dec 2006 – July 2008

Duties and Responsibilities:

• Compared the protocol with CRF design for consistencies.

• Involved in data review and data cleaning activities.

• Conducted periodic reconciliation of SAEs.

• Participated in discrepancy management.

• Involved in developing edit check specifications and data validation reports.

• Participated in study start-up activities involving UAT testing using EDC tools.

• Performed test data entry and run batch validations to identify errors in the database.

• Created and arranged data listings and report the same for use in CRF review.

• Queried the sites by generating DCFs to resolve discrepant data.

• Performed QC based on reviewing updated CRFs and DCF responses and fixed the errors.

• Worked on both paper based and EDC studies.

• Assisted the data managers in the preparation of the standard reports.

• Participated in project meetings with clinical team discussing data discrepancy issues.

• Tracked discrepancies and resolutions while maintaining proper documentation in

accordance with SOPs and GCPs.

• Interacted with clients and clinical study sites.

THERAPEUTIC AREAS:

Oncology, Cardiovascular diseases and Infectious Diseases

EDUCATION:

Master of Science in Biotechnology (University of Houston, TX) Dec 2009

Bachelor of Engineering in Biotechnology (Shivaji University, India) May 2007

TECHNICAL SKILLS:

MS Word, MS Excel, MS PowerPoint, MS Access, MS Outlook

EDC tools- Medidata Rave

RDC tools – Oracle Clinical

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