Sr Data documentation Officer (study manager) Resume
Short RESUME
Name: Mrunmayee T. Samant
(Maiden: Mrunmayee R. Ajgaonkar)
SUMMARY OF EXPERIENCE:
Total work Experience years
• Since last years working as Sr. Data Documentation officer in Altana Pharma Pvt. Ltd (Now Nycomed Inc.).
• Lecturer in college for under graduates (Teaching) – year
JOB PROFILE IN DETAIL:
) 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.
) Job profile as “Data Documentation Officer”
• Worked on 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.
) 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.
