1. Irfan Mohammad CV +91 7406294706
1
Irfan Khan Mohammad
Pharmacology Graduate
Profile
Focussed, committed and determined Pharmacology graduate, with 2.4 years of Clinical Data Management
experience. Key strengths include excellent analytical and problem solving skills, as well as good organisational
and team leading skills. Looking for an opportunity to utilize my clinical knowledge and experience in impacting
the success and growth of clinical Data Management group.
Academic Qualifications
COURCES INSTITUTE YEAR SPECIALIZA TION GRADE
M. Pharmacy Bapatla college of pharmacy,
Guntur(D.T), A.P.
2011-2013 Pharmacology 76.6%
B. Pharmacy
Vikas college of Pharmacy,
Vissannapeta, A.P.
2006-2010 Pharmacy
70%
Intermediate
Ganghadhar junior college,
Visakhapatnam (D.T), A.P.
2003-2005 Bi.P.C 90.6%
S.S.C
The Sun School, Vizianagaram (D.T),
A.P.
2002-2003 - 89.3 %
Skills & Competencies
- Good understanding of drug development process, clinical trial methodology and medical terminology
- Understanding of ICH-GCP and applicable regulatory guidelines
- Proven mentoring skills
- Self-motivated with strong leadership and communication skills
- Demonstrated ability to function effectively autonomously or as part of a team
- Ability to demonstrate initiative and pro-activeness
Data Analysis & Reporting
- Experienced in statistical analysis using MS Excel
- Capable of following instructions and communicating effectively with colleagues and external agents
- Competent user of MS Office applications with basic knowledge of SAS software
- Proven ability to learn new technologies and techniques rapidly and effectively
Technical Skills:
SAS Tools: SAS/BASE.
Medidata Rave, InForm 4.6 & InForm 5.5
Operating Systems: Windows.
Bangalore
+91 7406294706 Irfan.khan@yahoo.com
2. Irfan Mohammad CV +91 7406294706
2
Employment History
CDC, Quintiles, Bangalore, India (From Apr2014 to till date)
Responsibilities:
Provide leadership in the role of the Data Operations Coordinator (DOC).
Serve as Data Operations Coordinator (DOC) for two global studies and as a resource in 3
studies.
Manage delivery of projects through full data management study life-cycle.
Provide inputs on designer activities for technologies not requiring extensive programming.
Provide professional DM input to Clinical Trial Team(s).
Updating Post Production Changes Form (PPCF) for the faulty edit checks and followed up with
the programmer and LDM till it’s implemented.
Communicate with Third Party Vendor (LABS, ECG, IVRS, and SAFETY) to get the status on
the external data load.
Freeze and lock data as appropriate in time for statistical review, blinded interim quality review,
interim and final database lock.
Perform comprehensive data management tasks including data review, writing and resolving
data clarifications.
Perform assigned data management activities with focus on quality and timelines as per trail
specific documentation
Creating and maintaining Quality Control plan as per the work instructions.
Serious Adverse event reconciliation.
Coordinate with the LDM and TDM to track and report status and progress of data management
for allocated trails and to ensure smooth and successful timely locking of database
Coordinate with the Lead Data Manager within team to ensure that assigned trial is managed
efficiently with high quality
Escalate issues and trends in database in a timely manner to the TDM/LDM
Responsible to provide oversight on data management activities in the absence/unavailability of
TDM
Ensure coding is being performed to Data Coding Guidelines.
Ensure Non-CRF Data imports are occurring as defined in the guidelines.
Ensure that all deviations to SOP's and planned procedures, whether significant or insignificant;
planned or unplanned are documented in the DHR.
Generate status reports and provide to CPM / Clinical, as appropriate.
Request data Transfer as per Bios request and provide clean datasets for Bios review.
Managing Local Lab Reference Ranges (Perform QC and update in database as required).
Knowledge on project finances on maintaining proper realisation for studies.
Certification
Certified in Barnett Internationals for Good Clinical Practice in Clinical Trials, 2015
Personal Information
Gender: Male
Nationality: Indian
Declaration
I declare that the above written particulars are true to the best of my knowledge and belief.
Place: Bangalore.
Date: Irfan Mohammad