Pradeep Jacob
Clinical Data Science Leader
Hyderabad
Summary
Total 20 years of experience in Clinical Research Domain. Managed different business groups (FSP & FSO) and departments (CDM & PV). Proficient in all aspects of Clinical Data Management (Start-up to Close-Out). Highly organized and self-motivated professional experienced in project management, team development and process improvement. Skilled in developing and implementing strategies to increase efficiency and performance. Passionate about driving business growth and creating positive work environment.
Excellent interpersonal skills. Strong organizational and leadership skills.
Overview
21
21
years of professional experience
2
2
Certifications
4
4
Languages
Work History
Associate Director, CDM
Syneos Health Pvt Ltd
12.2020 - Current
- Performing Management Oversight from India for Global & India Led projects
- May serve as DM POC to Sponsor, External Vendors & Internal Stakeholders
- Responsible for the planning, execution & completion of study deliverables/ milestone, along with study LCDM, on the defined timeline with the defined quality
- Work with Study Leads & Project Managers on the project timelines, project progress, scope, budget, resource requirement, early detection of issues or any trend setting which may impact project timelines/deliverables & quality, initiation of necessary CAPA and Training Plans (if required)
- Collaborates with internal cross-functional teams and 3rd party vendor to define & execute the data integration process into Clinical CDMS
- May lead governance call between Sponsor & Syneos to provide Project Status updates, potential issues & risk and Sponsor expectation
- Involve in the Department Hiring Planning & Participate in interviews/ recruitment drive
- Support Study LCDMs (on need basis) in collating and presenting the Study/Program level Metrics/ data for the Clients Monthly Meeting
- On Monthly basis, collate metric data from Study LCDMs & represent to Senior Management the Study Health Index of the Oversight Studies
- Participate in internal or external audits (needed basis)
- Manage the resourcing & work allocation of direct associates and their relevant projects
- Also, manage their billable and non-billable time, and subsequently monitors their productivity / utilization
- Works on the Performance Reviews, Development Plans, Career aspiration, Appraisal and Promotion for the direct associates & daily administrative responsibility
- Ensure direct reportees are compliance with department SOPs/ WIs, company policies, project specific trainings
- Mentor DM staff on the DM processes, department SOPs, Work Instructions
- Recognizes & Rewards Staff on their achievement in timely manner through various Rewards and Recognition programs/ platforms, through emails & Townhall
- Responsible in maintaining company defined attrition level within team
- Provides inputs or work on the Project Proposals & Costing from department perspective on the received RFIs/ RFPs
- Lead & participate in process improvement/departmental strategic initiatives (likes UAT Initiative/ Start-up Team) to bring efficiency, expertly & quality to Database Build
- Act as a Departmental SME in SOP/ WI, Task-Wise Training development
- Support & Work on the company level broader initiatives like Employee Retention, India Development Strategics & Flexi/ Bench Resource.
Manager, CDM (FSP & FSO)
Syneos Health Pvt Ltd
07.2010 - 11.2020
- Managed Data Services in both the business unit (i.e
- FSP & FSO)
- Managed ~102 (direct & indirect) Management & Operational staffs from India
- Shared Responsibility of meeting the Study timelines, deliverables & their qualities
- Provided day to day managerial oversight to DM, SDTM & DB Programmer staff from India
- Served as an Oversight and Project Manager on India Lead Studies in Full Service business
- Served as an Oversight Manager for Global Studies/Projects (India Resourcing perspective) in Full Service Business
- Worked with PM, Operational Managers & Project LCDMs on Study Budgets and Scope of Work (SOW)
- Worked on Study Costing and Proposals from department perspective
- Worked on all quality issues/SQI/CAPA with Managers & Leads
- Accountable for maintaining the utilization of direct and indirect associates per company norms
- Involved in maintaining training records & compliance of all associates
- Involved in the Resource Management activities like Project Assignment, Resource Forecasting and Volume Projection
- Responsible in maintaining company defined attrition level within team
- Support Leads & Managers for collecting and providing Monthly Study/Program Metrics and SLA to client
- Collated & Represented the Monthly Study Health Index of Oversight Studies/Program to Senior Management
- Involved in Recruitment Strategics & Process
- Take care of on/ off-boarding process of resigned direct associates
- Involved in Annual Appraisal, Promotion cycle and Performance Review of direct associates
- Responsible in resolving administrative issues of direct associates
- Propose Team Members to various Rewards and Recognition program to accolades their efforts
- Actively involved in Process Improvement Initiatives set-up within Clinical Data Management department
- Involved in various company initiative and groups like SOP Knowledge, CIC & EAC Committee.
Clinical Data Analyst
Syneos Health Pvt Ltd
08.2006 - 06.2010
- Act as Study POC from India on shared data management project(s)
- Assist LDM on their Project/studies activities to meet the study timelines
- Coordinated and assign the weekly work to Data Management staff assigned on the project
- Trained/Mentor new employees on project-related data management procedures and guidelines
- Create the data management plan for the study/project lead from India
- Annotate CRF and Prepare CRF Completion Guidelines
- Perform database/ Edit Check UAT created by Database Programmers
- Define and Write edit checks as required for the study/project
- Perform regular data review and query generation tasks
- Track study progress and update Line Manager periodically
- Discuss and finalize Study/Project Milestone Timelines with Project Manager from DM perspective
- Interact with Client/Internal Stakeholder over telecom on the periodic basis
- May assist in the creation and documentation of new or revised departmental procedures and guidelines
- Ensure the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor
- Worked exclusively on Oracle Clinical OC-RDC & OC Classic CDMS.
Data Documentation Officer
Altana Pharma Pvt LTD
05.2005 - 08.2006
- Worked in role of Data Documentation Officer
- Carried out Data Entry as per project specific Data Entry Guidelines and Clinical Data Management Specifications (CDMS)
- Removed the discrepancies within primary and secondary data-entries via compares program
- Tracked and filed Case Record Form (CRF)/Lab Reports/ECG/Clinical Data Clarification Forms (CDCF) as per project specific Data Tracking Guidelines
- Performed verification of updated database through Edit-checks program
- Created and resolved queries
- Performed Quality Control (QC) for critical items
- Filed study related documents
- Performed the duties delegated by Data Manager/Designate
- Attend project teleconferences with study team
- Mentoring and assisting new joiners in their daily activities.
Data Analyst
D&O Clinical Research Organization
02.2004 - 05.2005
- Worked in role of Data Analyst
- Carried out Data Entry as per project specific Data Entry Guidelines and Clinical Data Management Specifications (CDMS)
- Removed the discrepancies within primary and secondary data-entries via compares program
- Tracked and filed Case Record Form (CRF)/Lab Reports/ECG/Clinical Data Clarification Forms (CDCF) as per project specific Data Tracking Guidelines
- Performed verification of updated database through Edit-checks program
- Created and resolved queries
- Performed Quality Control (QC) for critical items
- Filed study related documents
- Performed the duties delegated by Data Manager/Designate
- Attend project teleconferences with study team
- Mentoring and assisting new joiners in their daily activities.
Medical Representative
Warren Pharmaceuticals
10.2003 - 01.2004
- Worked as a Medical Representative.
Customer Support Executive
Wipro E-Peripherals
05.2003 - 09.2003
- Worked as a Customer Support Executive.
Education
Master of Science - Mathematics
Alagappa University
Tamilnadu 04.2001 -
Skills
- Team Collaboration and Leadership
- Organizational Development
- Decision-Making
- Analytical Thinking
- Coaching and Mentoring
- Administrative Support
- Onboarding and training
- Resources Allocation
- Work Planning and Prioritization
- Hiring and Training
- Performance Evaluations
- Project Management
Previousroles
- Manager, CDM (FSP & FSO), 07/2010 to 11/2020, Managed Data Services in both the business unit (i.e. FSP & FSO)., Managed ~102 (direct & indirect) Management & Operational staffs from India., Shared Responsibility of meeting the Study timelines, deliverables & their qualities., Provided day to day managerial oversight to DM, SDTM & DB Programmer staff from India., Served as an Oversight and Project Manager on India Lead Studies in Full Service business., Served as an Oversight Manager for Global Studies/Projects (India Resourcing perspective) in Full Service Business., Worked with PM, Operational Managers & Project LCDMs on Study Budgets and Scope of Work (SOW)., Worked on Study Costing and Proposals from department perspective., Worked on all quality issues/SQI/CAPA with Managers & Leads., Accountable for maintaining the utilization of direct and indirect associates per company norms., Involved in maintaining training records & compliance of all associates., Involved in the Resource Management activities like Project Assignment, Resource Forecasting and Volume Projection., Responsible in maintaining company defined attrition level within team., Support Leads & Managers for collecting and providing Monthly Study/Program Metrics and SLA to client., Collated & Represented the Monthly Study Health Index of Oversight Studies/Program to Senior Management., Involved in Recruitment Strategics & Process., Take care of on/ off-boarding process of resigned direct associates., Involved in Annual Appraisal, Promotion cycle and Performance Review of direct associates., Responsible in resolving administrative issues of direct associates., Propose Team Members to various Rewards and Recognition program to accolades their efforts., Actively involved in Process Improvement Initiatives set-up within Clinical Data Management department., Involved in various company initiative and groups like SOP Knowledge, CIC & EAC Committee.
- Clinical Data Analyst, 08/2006 to 06/2010, Act as Study POC from India on shared data management project(s)., Assist LDM on their Project/studies activities to meet the study timelines, Coordinated and assign the weekly work to Data Management staff assigned on the project., Trained/Mentor new employees on project-related data management procedures and guidelines., Create the data management plan for the study/project lead from India., Annotate CRF and Prepare CRF Completion Guidelines., Perform database/ Edit Check UAT created by Database Programmers., Define and Write edit checks as required for the study/project., Perform regular data review and query generation tasks., Track study progress and update Line Manager periodically., Discuss and finalize Study/Project Milestone Timelines with Project Manager from DM perspective., Interact with Client/Internal Stakeholder over telecom on the periodic basis., May assist in the creation and documentation of new or revised departmental procedures and guidelines., Ensure the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor., Worked exclusively on Oracle Clinical OC-RDC & OC Classic CDMS.
Certification
Certified Lean Six Sigma: Green Belt Professional
Previousemployers
- Altana Pharma Pvt LTD, 05/2005 to 08/2006, Data Documentation Officer
- D&O Clinical Research Organization, 02/2004 to 05/2005, Data Analyst
Previousworkexperience
- Warren Pharmaceuticals, 10/2003 to 01/2004, Medical Representative
- Wipro E-Peripherals, 05/2003 to 09/2003, Customer Support Executive
Therapeuticexperience
- Oncology
- Dermatology
- Endocrinology
- Cardiovascular
- Respiratory
- General Medicine
Educationalqualification
Mathematics, Statistics, Computer hardware and Networking
Currentemployer
Syneos Health Pvt Ltd, 08/2006 to present (15 + years), Associate Director, CDM, 12/2020 to present, Performing Management Oversight from India for Global & India Led projects., May serve as DM POC to Sponsor, External Vendors & Internal Stakeholders., Responsible for the planning, execution & completion of study deliverables/ milestone, along with study LCDM, on the defined timeline with the defined quality., Work with Study Leads & Project Managers on the project timelines, project progress, scope, budget, resource requirement, early detection of issues or any trend setting which may impact project timelines/deliverables & quality, initiation of necessary CAPA and Training Plans (if required)., Collaborates with internal cross-functional teams and 3rd party vendor to define & execute the data integration process into Clinical CDMS., May lead governance call between Sponsor & Syneos to provide Project Status updates, potential issues & risk and Sponsor expectation., Involve in the Department Hiring Planning & Participate in interviews/ recruitment drive., Support Study LCDMs (on need basis) in collating and presenting the Study/Program level Metrics/ data for the Clients Monthly Meeting., On Monthly basis, collate metric data from Study LCDMs & represent to Senior Management the Study Health Index of the Oversight Studies., Participate in internal or external audits (needed basis)., Manage the resourcing & work allocation of direct associates and their relevant projects. Also, manage their billable and non-billable time, and subsequently monitors their productivity / utilization., Works on the Performance Reviews, Development Plans, Career aspiration, Appraisal and Promotion for the direct associates & daily administrative responsibility., Ensure direct reportees are compliance with department SOPs/ WIs, company policies, project specific trainings., Mentor DM staff on the DM processes, department SOPs, Work Instructions., Recognizes & Rewards Staff on their achievement in timely manner through various Rewards and Recognition programs/ platforms, through emails & Townhall., Responsible in maintaining company defined attrition level within team., Provides inputs or work on the Project Proposals & Costing from department perspective on the received RFIs/ RFPs., Lead & participate in process improvement/departmental strategic initiatives (likes UAT Initiative/ Start-up Team) to bring efficiency, expertly & quality to Database Build., Act as a Departmental SME in SOP/ WI, Task-Wise Training development., Support & Work on the company level broader initiatives like Employee Retention, India Development Strategics & Flexi/ Bench Resource.
Personal Information
- Date of Birth: 07/11/80
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Associate Director, CDM
Syneos Health Pvt Ltd
12.2020 - Current
Manager, CDM (FSP & FSO)
Syneos Health Pvt Ltd
07.2010 - 11.2020
Clinical Data Analyst
Syneos Health Pvt Ltd
08.2006 - 06.2010
Data Documentation Officer
Altana Pharma Pvt LTD
05.2005 - 08.2006
Data Analyst
D&O Clinical Research Organization
02.2004 - 05.2005
Medical Representative
Warren Pharmaceuticals
10.2003 - 01.2004
Customer Support Executive
Wipro E-Peripherals
05.2003 - 09.2003
Master of Science - Mathematics
Alagappa University
04.2001 -
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