Summary of the profile
With total of 10+ years of clinical data management experience, I have progressively managed complex & large data management projects. Exposure to different client standards and processes provided me significant experience and capability to deliver high quality databases. I have coordinated large CDM teams and mentored & trained new team members.
Protocol review for DM section, CRF designing using MS-word, DMP, eCRF completion guidelines creation, Edit check creation, Lab Data Transfer Specification document creation, Creation of Annotated CRF, eCRF specification, Discrepancies Management, Reconciliation of external data (Lab, ECG, MRI, CTMS and IVRS/IWRS), SAE reconciliation, Quality review, Study status reporting, Database locks Procedure, Resource Forecast/ Management, Mentoring/Coaching new Joiners
Application/ Tool: IReview/JReview, Toad, Eclipse, Oracle Discoverer, iDART
CDMS: ClinTrial 4.5, OC/OC-RDC 4.5.3, DataFax, InForm 4.5, RAVE 5.6.4
Strategic roles performed:
· Handled roles like Project Manager and Lead Data Manager
· Responsible for operational delivery for Overseas Client projects in Data Management
· Resource management
· Line Management with a Span of control of 6-10 employees
· Process management and experience in all aspects of clinical data management.
· Process streamlining. Responsibilities encompass activities of project account, delivery and operations management, client relationship management in the Life Science sector.
A] Tata Consultancy Services Ltd. [August 2014 – Till date: Assistant Manager]
· Provide coordination, leadership and support to upper and lower management to ensure consistent performance leading to successful completion of the projects according to applicable quality standards.
· Ensure that the project status is followed regularly and provide reliable data to upper management and client
· Directly responsible for utilization of staff and ensure proper resource is maintained for successful completion of the project.
· Collect, analyze and interpret important information about ongoing projects on regular basis, set up and develop effective tools and procedures for data collection and data capture.
· Resource management and Process streamlining
· Responsibilities encompass activities of project account, delivery and operations management
· Process management and experience in all aspects of clinical trial operations and data management.
· Plan, communicate, drive and track CDM study activities to meet client timelines, milestones and agreed upon SLAs.
· Review protocol and provide comments to the Protocol Author prior to finalization.
· Define resource requirements and work with supervisor to prioritize resource assignments across projects.
· Participate in the implementation of new processes and technology.
· To communicate with Clients as a single point of contact
· Assisting in the development of Project plan as per company/client standards and providing feedback to team
B] PAREXEL International India Pvt Ltd. [December 2011 – August 2014: CDA III]
· Effectively communicating with all the stakeholders of projects including internal and external clients, vendors.
· Training/Mentoring the resources on various assigned task for the project and oversees the Quality of work performed.
· Identifying the Data trends during the Data review and providing relevant feedback for training needs of sites to clients.
· Implementing the feedback provided by the cross function teams on provided specifications and to ensure best practice is followed.
· Development of Data Validation Specifications (Edit Check), eCRF completion Guidelines, Data review guidelines as per the company/sponsor requirements and standards.
· Working on change requests as per changes in guidelines or protocol amendments.
C] Cognizant Technology Solution [May 2010 – December 2011: Data Analyst]
· Ensure that the DMP documents are prepared and updated as per requirement.
· Track metrics specified in the data management plan (DMP).
· Perform data management activities as defined on the assigned project in a timely and efficient manner.
· Provide ad-hoc data listings to the study team as per requirement.
· Provide inputs if any proactively to improve the process and or quality.
· Perform database audit as part of Quality Control.
· Perform Device data reconciliation
D] Lambda Therapeutic Research Pvt. Ltd. [June 2007 – May2010: Sr. Data Coordinator]
· Database designing using Clintrial 4.5, Database testing.
· Designing and review of study specific CRF’s.
· Preparation/Review of Data Management Plan.
· Acquisition and management of external data like Lab Data and ECG data
· Validation and review of clinical data using ‘ClinTrial’ Data Management System.
· Graphical report generation using I-Review.
· Data retrieval for statistical analysis.
· Handling of CRF’s at Data Management Center.
E] Mphasis India (Pvt) Ltd. [Sep 2006 – May 2007: Sr. Executive]
· As a Customer Care Executive, handling of calls of Customer. Listen the query carefully and answer the same.
· Resolve the query of customer according to their Request/Complaint. Maintain the standard quality record as per client need.
· Bachelor’s Degree in Science from Gujarat University
Year: 2006, Main Subject: Biochemistry
Other courses and Training
· Attended training workshop on Advanced Good Clinical Practice conducted by Lambda Therapeutic Research Limited, Ahmedabad
· Trained on CDISC Implementation in CDM by Phase-Forward, Germany (Jan 2008)
· Attended first annual conference of ISCR, Mumbai (Jan 2008)
Awards and Extracurricular activities
· Awarded with prestigious ‘Good Job’ award 2 times which was recommended by Head Clinical Data Management for valuable contribution as Project leader, keeping project confidentiality consistently.
· Awarded 2 times with ‘Good Team work’ this was recommended by Head Clinical Data Management for completing 4 projects in given timeline.
· Awarded with ‘Opel Award (Employee of the month)’ 3 times, this was recommended by Project Manager-CDM, for executing the projects as per the SLA.
· Green belt certified: completed project on Clean Patient Tracker automation
· Address : G-201, Devnandan Residency, B/H Gangotri Bungalow, Nikol, Ahmedabad Gujarat- 382350, India
· Date of Birth: 15/04/1986
· Marital Status: Married
· Nationality: Indian
· I hereby declare the above details are true and correct to the best of my knowledge. It would be pleasure to work with your firm.
Date: (Kalpesh Patel)