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Study Data Lead

Introduction

Would you like the opportunity to work in a dynamic, young environment? Are you interested in your personal growth, as well as your career’s?


Tata Consultancy Services (TCS) is an IT services, consulting, and business solutions provider that has been partnering with the world’s largest businesses in their transformation journeys.

Function

    Primary Responsibilities
  • Provides support and training on the Clinical data management activities to TCS Data Managers for the relevant functional processes/work statements/projects – be trained and perform as back up where required
  • Maintains & builds awareness of internal and external clinical Data Management practices to enhance domain expertise
  • Single point of contact for clientStudy Data Manager / designee
  • Overall in-charge of all Data Management activities for a study/ies including Study Set up, Conduct and Close Out.
  • Primary point of contact for CDM and works are liaison for CP, DAS and CCS activities too
  • Monitors and evaluates overall study progress, identify the potential risk / challenges faced during the course of the study
  • Conducts regular team meetings for study updates and provides guidance on study related issues to clientas well TCS internal teams
  • Monitor, maintain & report KPI / SLAs /metrics on the study
  • Performs tasks/activities as communicated by the TCS Group Leader (GL) and / or Project Manager (PM) and clientStudy Data Manager (SDM)
  • Ensures adequate resource for the Study throughout its lifecycle in collaboration with Group leader and informs client (SDM and/or Alliance Manager (AM) as applicable) contact of any changes in staff
  • Keeps TCS Group Lead & Project Manager fully informed about the need for the resources so the resource requests can be finalized with clientAM and TCS PM
  • Keeps record of all activities to ensure the smooth flow of the study throughout its lifecycle
  • Set priorities and targets of the study within the CP, DM, CCS, DAS teams
  • Responsible for recruitment, selection, training of team members & managing attrition
  • Works as mentor for DM staff assigned on the study/ies

Additional Responsibilities

  • Provide regular status reports to TCS Group Lead and clientStudy Data Manager (SDM)
  • Proactively communicate / escalate the identified unresolved issues/challenges to TCS Group Lead and / or Project Manager and clientAlliance manager / Study Data Manager (SDM)
  • Communicate between different stakeholders and clientStudy Data Manager (SDM)
  • Identify training needs for team members and maintains documents of staff training assessments including updates.
  • Actively contributing in creation of Investigator Meeting slides and attending the SMT meetings
  • Responsible for ongoing monitoring & development of study team at functional level

  • Assist Group lead in recruitment and selection of the team members from a domain technical evaluation perspective
  • Responsible for assessing the performance of Data Managers and reporting the progress to TCS Group Lead
  • Ability to work on multiple database set-up, locks, data review, cleaning, coding, SAE reconciliation, and some CRO or vendor interface
  • Person filling the position shall perform any other task given by her/his supervisor, which belongs to this position by its nature or her/his experience or education meets the requirements to perform.

Quality Related Job Accountabilities

  • Follows regulations and company policies, and complies with all clientStandard Operating Procedures
  • Demonstrates a continuous improvement mindset, by identifying and recommending opportunities to streamline or improve processes
  • Completes all assigned mandatory training by the designated due date
  • Provides support as needed for internal and external audits/inspections
  • Ensure the team members deliver high quality work and follow effective Data Management processes within the function

Ensures compliance of the team with all relevant client and TCS SOPs and all documentation requirement of staff training / assessments


Requirements


· Computer Literate (good knowledge of MS Office)

· Excellent Technical skills, start-up knowledge is must

· Excellent verbal and written skills, good organizational, interpersonal, and team skills

· Project management & result orientation

· Excellent Planning and Organizing skills

· Strong knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology

· Knowledge of PL/SQL is not required, but will serve as a recommendation

· Ability to work across scientific and technical disciplines

Offer

WHAT DO WE OFFER?

In our Shared Service Center you can taste the world by working together with more than 90 nationalities. As part of the Tata Group, India’s largest multinational business group, TCS has over 450,000 of the world’s best-trained consultants in 46 countries.


This position belongs to the BPS (Business Process Solutions) unit. This unit is helping enterprises achieve significant and sustained business outcomes by leveraging our deep domain expertise and operations.

As a future TCSer, you will be provided with:

  • A career path that will allow you to become a Subject Matter ExperGet trained on various competencies and skills
  • A great diversity of cultures
  • Language courses and training
  • On-site relax & gym rooms
  • Volunteering, sport and employee events

Information

Andrea Ignatakova

andrea.ignatakova@tcs.com

+36 30 448 3561

Application

Andrea Ignatakova

andrea.ignatakova@tcs.com

+36 30 448 3561