Data Management Lead II, based in Poland or Romania
- Employer
- Parexel
- Location
- Romania;Homeworking
- Salary
- Competitive
- Start date
- 22 Jul 2024
- Closing date
- 17 Aug 2024
View moreView less
- Discipline
- Data Management / Statistics, Clinical Data Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Picture Yourself At Parexel:
The Data Management Lead ll works with minimal guidance from their Line Manager and/or Subject Matter Experts. DMLs may act as a mentor for ADMLs or other DML peers. May act as Project Leader for projects involving only Global Data Operations services.
What You'll Do At Parexel:
- Manage and coordinate the integration and utilization of all ancillary systems as appropriate
- Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan
- Review and analyze metrics to derive meaningful summary of study health and trends
- Review of the Master Services/Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators
- Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs
- Portray Parexel's technical and operational expertise and capabilities, and tailor to meet sponsor's specific needs
- Create relevant slides with cross-functional Global Data Operations input as appropriate
- Maintain inspection-ready Trial Master File
- Identification of quality issues, ensuring they are raised in relevant system and closed according to requirements
- Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies
- Drive and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate - share lessons learned across multiple projects within a program or therapeutic area
- Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools
- Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope
Ideal candidate will possess:
- Written and oral fluency in English
- Proven data management experience in clinical research industry (CRO/Pharma)
- Proven record of leading project and program teams
- Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
- Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
- Awareness of SDTM/CDISC/CDASH standards
- Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data
- Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products
- Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
- Proficient presentation skills
- Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust
- Proven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
#LI-REMOTE
Company
When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.
How to describe Parexel’s culture in one word:
Working With Heart™ - Christina's perspective:
Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.
- Website
- http://www.parexel.com/
- Telephone
- +44 1895 238000
- Location
-
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert