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:
Required language level:
- English (higher advanced/fit for negotiation)
Employment type:
If you are interested, send your English CV to info@foxhr.hu
