Study Data Lead

ES-13463

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Location:

Budapest

Primary Responsibilities

  • Provides support and training on the Clinical data management activities to 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 client as well internal teams
  • Monitor, maintain & report KPI / SLAs /metrics on the study
  • Performs tasks/activities as communicated by the 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 Group Lead & Project Manager fully informed about the need for the resources so the resource requests can be finalized with clientAM and 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 Group Lead and clientStudy Data Manager (SDM)
  • Proactively communicate / escalate the identified unresolved issues/challenges to 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 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

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
  • Experience in Clinical Data Management is required
  • 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

WHAT DOES OUR PARTNER OFFER?

  • 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

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