Dr. Latha Padiyar

Maple Grove, MN Cell: 612-***-****

Email: ad4ckf@r.postjobfree.com

Experience in Clinical Research industry including review of clinical trial documents

Experience in ELVIS, GDMS, EDMS, e-TMF

●Essential documents required during all the phases of clinical trials and regarding all the regulatory submissions.

●Clinical Research fundamentals

●ICH GCP, Indian GCP, ICMR Guidelines

●Drug and Cosmetic act-Schedule Y, USFDA, European Union rules and regulations

●Principles of Pharmacology & Drug Discovery & Development

●Experience as PCA

Quintiles

Records Management Associate

Roles and Responsibilities:

●Managing client records/documents as per pre-defined SOPs.

●Quality Check of electronic trial master files.

●Review of client documents (including all documents related to clinical research worldwide.)

●Periodic project status report to the client, Pfizer.

Indegene LifeSystems

Clinical Trial Analyst

Roles and Responsibilities:

●Review of various clinical trial protocols and source documents.

●Clinical trial data analysis, tagging and updating the database.

●Advise data management staff on trial parameters, database designs, and validation of critical data.

●Progress reports and changes in clinical trials.

●Statistical analysis and competitive analysis of trial results.

●Development and maintenance of an Analytical, Competitive and Dynamic Clinical Trial interface Platform for General therapeutic indications clinical trials.

●Developed interface for therapeutic areas like Schizophrenia, Anxiety Disorders, Pain.

●Analyzing the clinical trial protocols registered in public domains like Clinicaltrial.gov, ANZ clinical trial registry, ISRCTN registry, Pub med, Journals.

●Analysis of clinical trial protocols for the Patient segment involved Inclusion, Exclusion criteria, safety and efficacy end points in the trials.

●Mapping results for completed and terminated trials by secondary research that describes safety and efficacy outcomes of the trials.

●Charting the Adverse events, Adverse drug reactions and SAE’s related to the clinical trials.

●Building indication and non-indication specific detailing for specific disease trials through secondary research.

●Qualitative and quantitative analysis of various trial results published in abstracts of various conferences.

●Contribution to the Clinical Trial interface by development of parameters related to the therapeutic area.

PCA

Experience in and as certified PCA

Educational Qualification:

Certification in PCA

Post Graduate Diploma in Clinical Trial Management from Cliniminds, Bangalore, India.

Bachelor of Dental Surgery from K.V.G Dental College, Sullia, India

P.U.C from S.D.M College, Ujire, India

Soft Skills :

M.S. Word, Excel, PowerPoint, Internet and all basic computer use.

Hobbies:

I play Volleyball and Badminton

I love to paint and I learn music.

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