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Deepu Joseph
Clinical Data Management Professional with
7 years of experience

Current: Associate Manager, Quintiles India
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..!
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.
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)
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.
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.
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.
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).
Education
• 2002 – 2004 ( CMRIMS, Bangalore University)
Master of Science in Biochemistry

• 1999 – 2002 S.B. College, Changanacherry, Kerala. (M.G University)
Bachelor of Science in Zoology ( Subsidiary Subjects ; Botany, Chemistry )

• 1997 – 1999 S.B. College, Changanacherry, Kerala.
Pre- Degree Course (M.G University)

• 1996 – 1997    Baselious English School, Kerala.
SSLC
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.

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Deepu Joseph

  • 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).
  • 9. Education • 2002 – 2004 ( CMRIMS, Bangalore University) Master of Science in Biochemistry • 1999 – 2002 S.B. College, Changanacherry, Kerala. (M.G University) Bachelor of Science in Zoology ( Subsidiary Subjects ; Botany, Chemistry ) • 1997 – 1999 S.B. College, Changanacherry, Kerala. Pre- Degree Course (M.G University) • 1996 – 1997 Baselious English School, Kerala. SSLC
  • 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.