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[QUOTE=Guest;171764]Curriculum Vitae
Name Full Syed. Habibullah
Designation Team Lead
Company Cognizant Technology Solutions, Hyderabad, 
 India.
[b]Email id [/b]: syedhabib26 AT gmail.com , syedhabib26 AT yahoo.in 
[b]Educational details  [/b]: 
Course Year of Passing Subject / Specialization Institution / University
 MSc. 2002 Applied Microbiology Periyaar University, Salem (T.N)
[b]Summary [/b]:
I am currently working with Cognizant Technology Solutions as a Team lead. 
I have 9 years of total professional experience. And I have 6.5 years of rich experience in Clinical Data Management. I have keen interest in exploring new technologies and implementing them for the best interest of the Organization. 
[b]Overall Therapeutic areas worked [/b]:
Worked on PhaseI-Phase 4 studies. I have overall project management experience. Worked on Therapeutic areas like Oncology, Women’s health, Endocrinology, Cardiology and Neuroscience.
I’m very good in planning and communicating with the team. I am self confident, self-learning and hard working. I possess strong leadership qualities, presentation skills Interpersonal skills. Positive attitude, Planning, Patience and Determination are my strengths.
[b]Work Experience  [/b]:
[b]1)Company [/b]: Cognizant technology solutions: (April 2011 till date)
[b]Designation [/b]: Team lead
 
[b]Job Role [/b]: 
- Lead and coordinate the day-to-day activities of the team (15 Nos)
- Perform data management activities for assigned projects and studies
[b]SCOPE OF CONTROL [/b]: 
- Junior Data Analyst.
- Data Analyst.
[b]OPERATIONAL RESPONSIBILITY [/b]: 
Technical
- Coordination of all the Data Management activities
- Review and provide inputs to study/project documents
- Perform data management activities on assigned projects
- Ensure timely and high quality delivery of data management deliverables
- Provide status reports to the client, internal management as required
- Participate in study team meetings, taking presentations.
- Archive all necessary information/documents for audit/inspections purpose
- Ensure compliance to applicable SOPs
- Support QC/QA processes on the project
 
 Supervisory responsibilities
- Tracking and approving leaves for team members
- Resignations / Abscond communication to Project Manager
- Ensuring timely submission of timesheets/ functional tracking spreadsheets by the team members.
- Timely Metrics capture and reporting
- Mentoring Team members. Taking presentations of project related activities.
- Contributing to the organization structure as and when required
- People management and resource/work allocation across projects.
- Provide regular feedback to team members and conduct appraisals
- Ensure completion of training records for all direct reports
- Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required
- Responsible for overall quality of deliverables from the team.
- Ensure compliance and Audit readiness among the team members
- Ensure appropriate distribution of work among direct reports 
- Help team members to enhance soft skills such as presentation skills, communication skills etc
- Participate in knowledge sharing sessions as an when applicable
- Handling team concerns, encouraging the team at work.
- Providing the feedback to the team members
- Maintaining study issues in issue tracker, attending study team meetings to provide updates to onshore DM team.
- Attending Video conferences with the leads to discuss team issues with Cognizant Project manager.
- Conducting regular team meetings to listen to team members concerns and providing resolutions and ideas to settle issues.
- Completing SOPs in time and ensuring team members to be compliant with all SOPs.
- Ensuring all the team members to attend scheduled trainings, maintaining training folders, and to ensure weekly Time sheet update.
[b]2)Company  [/b]: United Health Group Information Services - I3 statprobe (June 2009 to Apr 2011 )
[b]Designation [/b]: Clinical Data Manager
- Managing(mentoring and assigning various tasks on daily basis) a group of 20 members on a project as Lead and POC for the study for all DM activities handling all the onshore calls/meetings.
- Carry out validation procedure testing and provide feedback to the clinical database programmers.
- Working on Data Validation ie Discrepancy management in EDC studies (Inform) and Paper based studies (Clintrial).
- Responsible for 3 Studies(Oncology,Endocrinology and Neurology) for Data validation as Validation Lead.
- Worked on Lab data (as a Lab specialist) running different reports through I-review for 13 studies and sending issues to the Vendors for resolution and requesting for correct update of GLS (Generic Laboratory system) data maintained by the Third party.
- Creates , reviews and processes Data Clarification Forms and updates the database.
- Running Validation Log for errors. Sometimes running validation manually.
- Running Coding Log for uncoded terms.
- Performs other miscellaneous activities along with QC of database, Data Management processes and documentation as required.
- Regularly liaises with monitoring database programming, medical coding and statistical programming teams to ensure smooth functioning of a study.
- Performing SAE review and Manual review of CRF data (paper studies) and reconciliation of SAEs for both Inform(EDC ) and Clintrial (Paper) studies.
- Performing reconciliation of laboratory or any external (third party) vendor data.
- Proposes alternatives and solutions for improvement in quality of work.
- Sometimes providing trial progress reports to Clients.
- Involves in Interactive coding for Uncoded Medications. Running reports for uncoded Adverse events.
- Attended Client audits for many studies. Providing presentations to the Clients using MS excel and Powepoint.
- Received many times appreciations from Onshore team for my good performance and project management skills
- Received performance awards.
[b]3)Company [/b]: Reliance Clinical Research Services Pvt. Ltd. (3rd April 2007 to January 2009)
[b]Designation [/b]: Clinical Data Coordinator- 2
[b]Job Profile [/b]:
- All CDM activities like data validation, generating DCFs, Attending Telecons from Project managers to give study updates, preparing CRF filling guidelines, Global rulings,
- Discrepancy management.
- Preparing Edit checks .
- Preparing Annotated CRFs. 
- Preparing Dirty patients and clean patient for Testing of Edit checks.
- Performing SAE reconciliation between Oracle clinical database and Safety database maintained by Pharmacovigilance department to remove the inconsistency of data .
- Performing QC of data before database lock. 
- Lab data reconciliation.
- Medical Coding using MedDRA and WHO Drug dictionaries.
- Undergone Oracle clinical Training in RCRS for 1 Week. From DBMS Consulting corporation at Reliance.
[b]4)Company [/b]: Accenture Services (P) Ltd, Bangalore. ( 28th Mar 2005 to 30th Mar 2007) 
[b]Designation [/b]: Certified Data Validation Associate (CDVA)
[b]Job Profile [/b]:
- Ensures the completeness and validity of the Clinical trial data that has gone through
 data entry. 
 
- Review and Resolve discrepancies identified by the system or through manual checks as per guidelines.
- Generate and review Case Report Form summary report and track missing CRFs.
- Issue Data Clarification Forms to clinical trial sites.
- Perform database quality reviews documenting findings for use in assessing the quality index.
- Review, perform checks on the lab data
- Review all discrepancies set to Lab review and provide solutions.
- Collaborate with validation team to raise awareness and skill of the team in
 handling Lab data & provide support to update guidelines used to edit lab data.
- Ensure accurate application of validation guidelines referencing
 Global Thesaurus Management Team (GTMT) guidelines.
- Review the handling of uncoded terms edited by DVAs across therapeutic areas. This includes terms set to TMS evaluation, queries written and integration of
 DCFs for coding.
- Provide feedback to Leads for quality and efficiency improvement
 and ensure necessary corrective measures are taken.
- Accountable for providing updates to the Therapeutic lead and for 
 assisting the Therapeutic lead in making changes in the way in which
 study work is performed. Ensure efficiency of operations.
- Responsible for attaining and maintaining high quality
 (client acceptance) deliverables with efficient application of resource.
- Ensure timelines set by the client are met.
- Received many times performance awards.
 
[b]4)Company [/b]: Immunoshop Diagnostics Private Limited, CBD Belapur, Navi Mumbai. (July 2003 to December 2004)
[b]Designation [/b]: Marketing executive, Exp: 1.5 yrs
[b]Job Location [/b]: Bangalore.
[b]Job profile [/b]: 
- Selling/marketing the research /laboratory diagnostic kits like all kinds of proteins for assays, laboratory chemicals, monoclonal, polyclonal antibodies, enzymes to research labs like Aurigene, Biocon, SAMI labs and hospitals. 
- Meeting the doctors/pathologists at hospitals like Sagar Apollo, Manipal hospital, Wockhardt hospitals and convincing them about the quality of the products and explaining them about the kits that can be used to diagnose/analyse the protein levels in serum with high precision and accuracy.
- Giving live demonstrations about how a diagnostic kit works and running the assay if necessary on Semi autoanalysers, ELISA readers, Gamma counters(Radio immuno assays) and explaining about how to interprete the results accurately as per Instruction booklet provided with the kits.
[b]5). Company [/b]: Institute of Transfusion Medicine and Research (ITMR), Hyderabad worked from May 2002 to June 2003.
[b]Designation [/b]: Microbiologist
[b]Job profile [/b]: 
- Preparation of all kinds of Laboratory Medias for Bacterial and Fungal cultures.
- Handling blood cultures, fungal cultures, bacterial cultures performing sensitivity tests to identify bacteria in different specimens like blood, sputum, pus, urine, csf etc.
- Trained on blood drawing techniques.
- Performing all kinds of bacterial/fungal staining and identification techniques.
- Worked on Semi autoanalysers and ELISA readers for analyzing different protein/hormone(like anti HBs Ag, anti TB etc) levels in serum.
- Got well trained in performing HIV lab tests- CD4/CD8 cell estimation in whole blood samples in active AIDS patients who are under treatment.
- Performing all kinds of biochemical techniques like hormonal assays(like T3,T4,TSH etc) on BIOTRON Semi autoanalysers..
Skills & Knowledge:
- Pharma Basics: Research 
- Pharma Basics: Pre Clinical 
- Pharma Basics: Clinical Development and Regulatory act. 
- Standard operating procedures for Clinical Data Management
- Basic knowledge of Good Clinical Practice & International Conference
 on Harmonization.
- Basic knowledge of Pharma Regulatory Affairs in Clinical Research.
- Good technical knowledge of the process of Clinical Data Management.
- Strong interpersonal skills within the team.
- Proactive.
- Analytical approach.
 
Software Skills : 
Oracle Clinical 4.5.1
CDRS (Clinical data review system)
Discrepancy Tool set
RDC(Remote data capture) platform 
EDC (Electronic data capture)studies :
Tool: Inform ver 4.5 and Clintrial systems. 
I-review( Integrated Review system) 
J review.
Ms-Office ,
C programming Language.
Typing speed: 40 words/minute[/QUOTE]

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