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Data Management Lead I (based in Romania, Poland, Spain, UK)Job ID 69152BR Ireland - Any Region - Home Based
The Data Management Lead l provides leadership in all aspects of Data Management:
- Manages timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies.
- Data Management’s single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality.
- The Data Management Lead l works under the guidance of their Line Manager and may receive additional direction/support from an experienced Data Management Lead or Subject Matter Experts.
- They may work as a co-DML with an experienced DML or work independently on less complex trials.
- Bachelor’s degree as a minimum
- Written and oral fluency in English
- Data Management experience in clinical research industry (CRO/Pharma)
- Proven record of coordinating and supporting project teams
- Full understanding or willingness to learn and apply relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
- Basic understanding or willingness to learn and apply Parexel financial tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects
- Awareness of/or willingness to learn SDTM/CDISC/CDASH standards
- Prior experience in Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products.
- Ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
- Negotiation skills and ability to influence, in order to achieve mutually beneficial results
- Good interpersonal, oral and written communication skills, using concise phrasing tailored for the audience with a diplomatic approach
- Time management and prioritization skills, in order to meet objectives and timelines
- Evidence of strong problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
- Ability to travel as required
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