Time for something new

Study Data Lead

Have you managed study start up? Are you experienced in clinical data management? As a member of a multicultural team you will have the opportunity to coordinate them with programming and clinical data review and manage clinical studies.

Responsibilities:

  • Overall in-charge of all Data Management activities for a study including Study Set up, Conduct and Close Out.
  • Single point of contact for client Study Data Manager / designee
  • Works as mentor for DM staff assigned on the study
  • Maintains & builds awareness of internal and external clinical Data Management practices to enhance domain expertise
  • 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
  • Identify training needs for team members and maintains documents of staff training assessments
  • 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
  • Follows regulations and company policies, and complies with all client Standard Operating Procedures
  • Provides support as needed for internal and external audits/inspections

Requirements:

  • Fluent English
  • Excellent technical skills, start-up knowledge is must
  • Project management & result orientation
  • Experience in Clinical Data Management
  • Strong knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology

We offer:

  • Being part of the Top 10 Pharma company partner
  • Working in an international, young and dynamic team
  • Competitive salary and benefit package
  • Internal trainings and career path
  • Remote work (home office)

Sector (s):

  • Healthcare, Pharmaceutical Industry
  • Healthcare Specialist
  • Pharmacist

Experience required:

  • 1-5 years’ professional experience

Required Qualification:

  • University degree

Required language level:

  • English (higher advanced/fit for negotiation)

Employment type:

  • Full time

If you are interested, send your English CV to

Álláshirdető

Sagáth Zita

szenior recruiter

zita.sagath@foxhr.hu

Zita elsősorban olyan pozíciókkal foglalkozik, ahol a szakmai tapasztalat mellett a kiváló nyelvtudás is fontos szerepet kap, legyen az IT vagy akár jogi terület. Munkapszichológus tudásával és öt év interjúztatásban szerzett tapasztalattal várja a jelentkezőket.