1. Deepu Joseph
Clinical Data Management Professional with
7 years of experience
Current: Associate Manager, Quintiles India
2. My Family
Virtues that drive a strong family
also creates a great professional as I
believe that organizations are made
of people and strong relationships
make great organizations….
Sherin… my love , is a professional
with over 5 years experience in
CDM
Eva…..Our all in all…happiness of
our life !!!!!! Just turned one..!
3. Summary
With an overall CDM experience of over 7 years, I started the journey as a validation team
member and played significant roles in the data cleaning activities. Moving ahead with more
responsibilities of leading two trials as a SPOC (Single Point of Contact) for the customer,
successfully earned customer delight and confidence. In the role of a DOC (Data Operations
Coordinator), handled 7 protocols with around 15 study team resources with commendable
achievements and customer satisfaction. Always keen on Quality, understands the knowledge
requirements to meet the same and realizes that knowledge brings confidence. Currently
handling a team of 14 data managers and overseeing 10 trials under Immunology and
Infectious Diseases in the role of a Therapeutic Area Manager.
4. Experience- Current
Associate Manager, CDM, Quintiles Transnational 01 April 2010 – Present
Duration 1 Year 11 Months
• Leads a team of 14 Data Managers within an FSP team
• Responsible for the teams’ utilization, productivity, quality and compliance.
• Responsible for grooming the team and coaching them on professional development
• Responsible for engagement of the team thereby ensuring retention.
• Process Owner: Operational Work Streams
▫ QC processes and Metrics for the FSP unit, on trials with multiple business models with
different processes.
▫ Project Management Tools: Project specific business documentation with customer,
Responsible for compliance & maintanence across trials.
▫ Productivity: Lead the initiative of bringing accuracy to the data collection for productivity
calculations on different activities in the process.
• TAM (Therapuetic Area manager): Immunology (Phase1) & Infectious Diseases
▫ Handling customer relationships for 10 trials in the TA.
▫ Escalation point for the customer/ internal team incase of risks/issues.
▫ Accountable for delivery as per customer expectations in all the trials under my perview.
▫ Functionally engaging trial teams, sharing learning across the TA.
▫ Regular updates to the customer on the TA: face to face.
• Trainer:
▫ Trainer for the FSP unit on different DM processes and tools
▫ SME for customer tools used in the process. (Was trained and certified in the US- Customer
site)
5. Experience- Previous
Assistant Manager , CDM, Quintiles Transnational 01 April 2009 – 31 March 2010
Duration 1 Year
• Lead a team of 9 Data Managers
• Handled 7 trials as a Data Operations Coordinator (DOC), (Phase 2 & 3)
• Lead the development of metrics definitions and inturn collection of data and
• creation of operational metrics on the compliance of two processes for the
• FSP unit.
• Lead the revamping of data collection tool for operational metrics.
Sr.CDC- April 2008 to March 2009, (Duration1 year)
CDC- Oct 2006 – March 2008, (Duration 1 Year 6 Months)
ACDC-Dec 2004-Aug 2006, (Duration 1 year 8 Months)
Quintiles Transnational
• Data Operations Coordinator for 4 trials
• Data manager in several Phase 2 and Phase 3 trials across CVS, Hematology and Infectious diseases TA
• Worked in EDC and paper based clinical trials.
• Performed Discrepancy Management, database QC, edit check validation, data listing review, final QC for
paper trials etc.
6. Skills
Communication
Right communication is the key for any relationship. My interactions with the customer has
made me develop strong relationships with them. Proactively understanding the customer
expectations by asking right questions always build confidence on my leadership and trust within
customer’s minds. During issues or crisis, communicating the urgency and exclusivity of our
actions with transparency on what we do, really has made a difference and has avoided escalations
in situations where there was panic all around. Collecting maximum information on the topic
before communicating to anyone, helps provide details of the issue as per the need
As a Manager, constant connection with the people in the team is a vital part of creating a highly
engaged team. Regular one on one sessions and appreciation of work at the right time has always
created a loyal team for me, additionally was an effective coach in making my team professionally
strong.
Trainer
My technical expertise and vast experience in data management in different TAs, DM activities
and phases improves the interactions and enhances my ability to give practical examples to
simplify the understanding of the concept.
7. Skills
Operational Metrics
Defined and implemented metrics for Quality, Productivity and Compliance for the FSP operation. Sucssessfully
published metrics for the operations in the dashboard on monthly basis which is inturn shared with the customer
regularly.
Process Development
Lead the process development for QC process for the FSP operations, cascaded the same to different target
groups. Lead the implementation and monitored the compliance and generated metrics as per the defenitions for
the dashboard.
Was also involved in streamlining activities across different customer sites to have a single process to be followed
across different trials which was overseen by different customer sites. Liased between experts from different
customer sites and called discussions to review the process on a regular basis during the progress of this special
project.
People Management
I have been handling people fuctionallly over a period of 4.5 years now in my role as a DOC and TAM. Handling
line reports from last 2.5 years and have been able to maintain a good retention rates for the team over this period.
As a Line Manager, I am responsible for their engagement and takes care of their well being in the organization.
8. Skills
Project management
I have been involved in project management from last 4 years. As a Therapuetic Area Manager, I
am involved in planning and managing the delivery of the trials under my TAs. The project plans
from Data Team Leads are done with my supervision. Actively involved in making projections
monthly and annual projections for the resourcing team on the TA. Working with the trial teams
to make sure that all the risks have been identified and mitigations are planned. Helps the team
to bring in expert support from the larger organization as and when needed. Communicates to
customer with the project plans to avoid surprises. My experience as a DOC in several protocols
have helped me to contribute at the root level of details of the trial which inturn brings in
efficiency to the management of the deliverables.
Data Management
Thorough understanding and hands on experience on DM activities in start up, conduct and close
out phases of clinical trials. Have successfully driven trials through start up for Phase I, II and III
trials, well experienced in conduct activities like Discrepancy Management, SAE reconciliation,
ESP reconciliations, Adjudication data reconciliation and cleaning for CVS trials etc, also have
been part of many interim locks and final locks of databases for different trials.
Recruitment
Was a part of the interview panel (for DM-FSP) from last 1.5 years and was able to bring in lot of
good talents to the team.
Software skills
MS Word, Excel, Project Plan, Visio, Power Point. Medidata Rave, Clintrial, OC
Six Sigma
Trained on SIX SIGMA methodologies (from KPMG-internally) as a green belt (not certified).
10. Contact Me
• +91 9886735138
• deepjos@gmail.com
• Languages:
Malayalam is my mother tongue. I speak and write English brilliantly and
fluently. I know to write, read and speak Hindi.