Dr.

Suresh Kumar
Mobile: 9177771038
Email: suresh.1577@gmail.com
Flat 202, RLR Sapthapadi Towers, HUDA colony, Chanda Nagar,
Hyderabad-50
Accomplished Operational Management overseeing the cross functional
teams and Project Management responsibilities and now with a strong
penchant for senior leadership; recognised for exemplary performance
on this role.
OBJECTIVE
To Identify and secure a senior leadership position in Clinical
Research industry where I could implement my diverse experience in
clinical data management and cross functional operations including
project management and line management and align my practical
experience in managing clinical trails across diverse therapeutic
areas to the values and vision of the organization.

WORK EXPERIENCE
Manager (Global Technical Services, PAREXEL International Ltd)
Hyderabad Nov-2008-till date.
Responsibilities:
* Manage and oversee departmental activities including appropriate
resourcing of staff, staff assignments, and quality control of
project deliverables and timely delivery of project deliverables.
* Responsible to coordinate with client or account activities for
department/function.
* Participate in or contribute to project bids, including client
presentations.
* Ensure client and business needs are met and that all projects are
optimally resourced with suitably experienced staff.
* Ensure direct reports meet departmental and project productivity
and quality metrics by efficient execution of their project in
line with project plan and yet in assigned budget.
* Produce accurate resourcing plans in conjunction with appropriate
Project Team Members.
* Provide expertise and consultation, facilitate metrics collection
and develop action plans in conjunction with Project Leader/Lead
to keep projects on time and within budget.
* Drive team members to improve their efficiency and effectiveness
at prioritizing work and improving performance evidenced by the
work produced, client feedback, audit results and QC measures.
* Take appropriate action following regular feedback sessions from
internal client and external client through project management
teams.
* Implement process improvements, in conjunction with Management
team and Quality Management Group, in response to client and team
 feedback and quality audits.
* Evaluate departmental metrics, drive team members to meet
departmental goals
* Demonstrate excellent leadership skills within department. This
includes taking an active role in departmental, functional or
client specific activities (e.g., management meetings, SME
representation from the GTS group during organizational change and
SME representation on client specific process and procedures),
ensuring employees adhere to corporate policies and following up
with management as appropriate.
* Train and mentor new managers
* Undertake the full range of duties relevant to the leadership,
management and development of the team to ensure their performance
meets and or exceeds both the business and their own personal
goals/objectives
* Maintain a positive, results orientated work environment, building
partnerships and modelling teamwork, communicating to the team in
an open, balanced and objective manner
* Participate in formal staff review processes e.g. performance and
salary reviews to corporate standards and timescales.
* Procure the tools and technologies required for delivering the
projects.
Achievements:
* Successful in deploying a new global department from the stage of
defining the Job description of the roles to full scope
implementation across technologies (OC, OCRDC, RAVE, INFRORM and
DATALABS) The department will cater the start-up requirements in
the set-up phase of the project. The scope includes specifications
set-up for Database, DVS, export programs, mapping programs
especially to client/CDISC standards, reports and conduct the
functional testing of the all the activities including integration
testing of EDC system with IVRS/IMPACT/CTMS/ e-Data vendors.
* Billability rate of 85% was achieved within the first 3 months of
deployment, with the just in time training approach which has
fetched applause from the senior leadership team.
* Implemented the strategies as defined in the global framework for
the TA department within the first 6 months.
* Delivered the complete scope as defined in the JD with consistent
quality on 8 strategic client programs in the first 1 year after
the department was set-up.
* Nominated and Held responsible as change agent and SME for
facilitating the biggest organizational restructuring initiative.
* Nominated and held responsible as a TA work stream SME for Asia
region with one of the strategic partnership client accounts
(D-MDL).
Data Management Lead, PAREXEL International Ltd
Hyderabad Feb-2007-Nov-2008
Responsibilities
* Accounted to plan, manage and close the projects within the
timelines and budget and yet with the expected quality ensuring
the client KPI's are met.
* Provide inputs to project tools, project plan, and Quality Plan &
process improvements within the project.
 * Coordinate with global teams to set-up the project systems and
tools.
* Ensure the project has adequate resource for the complete duration
of the project and to ensure the required tools, trainings and
access is provided/granted.
* Organise and Participate in project initiation meetings with the
clients.
* Provide documented resolution to the project team issues/queries
through communication/interaction with sponsors.
* Participate/organize client, investigator, vendor, and project
team meetings during the entire course of project and coordinate
with external vendors to follow-up on the requirements.
* Communicate to team members the scope of work, timeline and
project goals, technical information, and input from Sponsor
throughout the project
* Prepare Project Plans, project status and other administrative
reports and submit to internal and external clients as per the
contractual obligation.
* Ensure to have audit ready project files/documents maintained
through out the project duration as per the document management
plan.
* Manage the project pro-actively, anticipating problems and
providing resolutions in a timely manner
* Responsible to forecast the project deliverables and monitor their
progress closely to ensure the timelines are met.
* Forecast revenues and recognize the forecasted revenues on the
project and report the variance, if any with explanation to the
project analysts (financial).
* Provide proactive solutions with the sense of urgency and client
focused approach to the client requirements thereby building trust
and strong client relationship.
* Generate business object reports to determine the actual against
the budget time and ask for explanation for the overruns and take
required actions.
* Identify changes in scope and liaise with Project Leader
* Responsible to address the audit findings, if any on the project
being audited and take corrective and preventive measures and
report to the auditors within the timeframe.
* Manage access control of project team on the project tools
(grant/revoke).
* Conduct lessons learnt meeting and take effective measures to
implement the lessons on current or future projects by publishing
the lessons in central repository (lesson learnt database).
*

Key achievements:
* Managed an entire suite of 7 complex phase 2 and 3 long term
studies (ranging from 15-22 years) that were run by 3 different
clients (due to multiple acquisition) and the challenge was to
set-up all the CRF versions, due to multiple clients managing
them, into one database. It was accomplished through a unique
dataset and re-entry strategy as some of the visits were 100%
clean.
* Accomplished global DVS Task Lead role for one of the strategic
client programs; completed DVS writing/review for more then 100
studies for the client.
* Delivered training in Tokyo on DVS and aspects of database design
to be considered in DVS set-up.
Assistant Manager (DM, QA/QC)/Clinical Data Manager, Asian Clinical
Trials, (a division of Suven Life Science's)
Hyderabad, 2005-Feb 2007.
Responsibilities:
* Ensure that the projects are conducted as per the SOPs, ICH GCP
and standard guidelines.
* Implement project ensuring timely deliverables without
compromising on the quality.
* In-charge of project initiation and planning:
1. Partake in the budget specification development process, scope of
work plan meetings and in the statistical analysis plan
development and approval process.
2. Evolve data management plan and explore key landmarks in project.
3. Chart, assess and approve Case Report Form (CRF) and source
document in collaboration with development team.
4. Undertake vendor assessment/selection and management for CRF
printing.
5. Validate database against the database design specifications and
development of data entry guidelines.
6. Evolve project specific data handling plan.
7. Impart training on Standard Operating Procedures (SOPs) and
project specific documents to the study team.
8. Partake in technical meetings with the client and vendors
regularly.
4. Contribute to the data management functional group objectives
through launch of best practices and procedures at work.
5. Account for project execution and control including conduct of
discrepancy management tasks, query management, and complete
processing of Non CRF data.
6. Handle the entire gamut of project close out including resolution
of clinical and statistical queries, supervision of database
quality control audit, formulation of quality manual and reports,
and ensuring timely deliverables.
Achievements:
* Handled several Clinical Data Management projects of Phase II, and
Medical Device products effectively using applications from Oracle
Pharmaceutical Application Suite.
* Gained cross functional exposure and was also involved in RFP's
for 12 proposals.
* Awarded 1^st rank in internal training quiz conducted as part of
annual training in CDM aspects and ICH Good Clinical Practices.
Process Analyst/Project Lead/ Certified Data Validation Associate,
Project ACE, Accenture Life sciences, Bangalore, 2003-2005
Responsibilities:
* Allocation of work to the project members and attend to their
concerns with respect to project and get the resolution for the
unattended concerns from the onshore leads.
* Assessed database and data quality at all the stages of data
management process to ensure completeness and authenticity of the
data at each stage.
 * Validated, drafted and locked data.
* Oversaw functioning of the CDM team and addressed their queries.
* Organised project review meetings, explored and resolved problems.
* Maintained study metrics and ensured timely project delivery.
Achievements:
* Conferred the Certified Data Validation Associate (CDVA
certificate) by Alliance of Clinical Excellence (ACE), Accenture
life sciences.
* Recipient of `Alliance Award' presented twice by Accenture in the
financial year 2004 for excellent performance.
* Recognised by Wyeth for exhibiting dedication and commitment in
NDA submission of a protocol.
* Conferred appreciation mails from data management liaison and
therapeutic Area Managers for draft and lock of database with QI
above the Service Level Agreement (SLA) with Wyeth
* Bagged the `Blue Ribbon Award' presented by Accenture for
exceeding the target with 46% with 100 % quality.

Previous Work Experience

* Medical Transcription (QC), HealthScribe India Ltd., Bangalore,
2001-2003
EDUCATION
* Bachelor of Dental Sciences, Kuvempu University (Davangere),
India, 2000
Professional Affiliations
* Member of Indian Dental Council (IDC)
* Drug Information Association (DIA)
ADDITIONAL INFORMATION
Training
* Training on OC, Data Labs, Rave, Inform, CTMS (Impact) and CDISC
standards.
* 2 Months extensive training on Data Management Project Manager
activities in South Africa office.
* Delivered training on DVS in Japan office.
* Internal training at Asian Clinical Trials on ICH-GCP, 21 CFR Part
11, 50, 54, 56, 312, ICMR guidelines, GCDMP, Schedule-Y
* Six weeks of intensive training by offshore CDM executives on CDM
principles, Oracle Clinical (OC) and externally reengineered and
integrated applications like Discrepancy Toolset (DT), Clinical
Data Review System (CDRS), Page Level Tracking (PLT), Status
Tracking Utility (STU), Source Document Clarification form
Unexpected pages and Data clarification Form Tracking System
(SUDS) and Thesaurus Management System (TMS)
Technical Skills
Operating Systems : Windows 2000, XP, Windows NT
Oracle Applications from OPA suite : Oracle Pharmaceutical
Applications (Oracle Clinical,
Thesaurus Management System)
E-Clinical technology : Inform, Rave, Data Labs, OC, OCRDC, IVRS, CTMS
Packages : MS-Office 2000, Adobe Acrobat
PERSONAL
Date of Birth: June 15, 1977
Marital Status: Married
Languages Known: English, Hindi, Telugu, Kannada and Tamil
Reference:
Reference will be provided upon request
Place: Hyderabad

Date: 2-Nov-2010
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