Sr Data documentation Officer (study manager)

Posted on: 2007-11-20

[email protected] Short RESUME Name: Mrunmayee T. Samant (Maiden: Mrunmayee R. Ajgaonkar) SUMMARY OF EXPERIENCE: Total work Experience 3 years • Since last 2 years working as Sr. Data Documentation officer in Altana Pharma Pvt. Ltd (Now Nycomed Inc.). • Lecturer in college for under graduates (Teaching) – 1 year JOB PROFILE IN DETAIL: 1) Sr. Data Documentation Officer (Clinical Research/Data Management) A) Appointed as Study Manager for respiratory studies: • Leading a group on respiratory studies. • Guiding and training the team on the study. • Preparing DE conventions to maintain the standard at the LOC. • Reviewing of Protocol, Data Check Manual, Case Record Form (CRF), Annotated- Case Record Form and all study related documents. • Keeping check and reporting of the work done by the team members within the study. • To carry out data validation checks for correcting inconsistencies in data. • Tracking and filing of CRF/Lab Reports/ECG/Clinical Data Clarification Forms (CDCF) as per project specific Data Tracking Guidelines. • To perform verification of updated database through Plausibility-check program. • To perform quality checks of CRF. • Creating and resolving of Queries. • To perform DE form validation checks. B) Appointed as a Trainer: • For Guidelines and Standard Operating Procedures of Altana Pharma. • For new employees on the software and the working tools, procedures and Data management activities. C) Appointed as a SOP co-ordinator: • Have prepared a matrix for the SOP and Guideline training for LOC India. • SOP coordinator for Data management activities. 2) Job profile as “Data Documentation Officer” • Worked on 4 different studies on almost all the Data management activities. • Keeping track of the incoming CRF’s. • To carry out Data Entry as per project specific Data Entry Guidelines and Clinical Data Management Specifications (CDMS). • Removal of the discrepancies within primary and secondary data-entries via Compares program. • Tracking and filing of CRF/Lab Reports/ECG/CDCF as per project specific Data Tracking Guidelines. • Filing of Study related Documents Other activities: a) Internal presentations in the company on - • Electronic Data Capture • Coding • Data Loading • Change Request • Data Management and its activities • Route of administration b) Represented LOC-India for an International Data Management conference for Altana Pharma in Germany and gave a presentation on the ‘Standard Operating Procedures’ of LOC. 3) Previous Job Profile: Lecturer in college for under graduates: Worked as a Lecturer for One Academic year in the department of Zoology for Degree College (under graduates) in subject of - Physiology and Anatomy - Theory and Physiology and Biotechnology - Practical Have taken many data management associated trainning from different professionls. E.g. ICH-GCP(Good Clinical Practice)-from Dr arun Bhatt-Clin invent, DE Form building, Medical Coding and many many more. Have a recommendation letter from immediate boss Ms Vindu Seal as well as a word of recommendation from MD Altana Pharma. Dr. Antal Hajos. detailed resume will be provided in word formate during the interview.