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Senior Data Management Lead - based in Poland, Romania, Hungary, UK

Employer
Parexel
Location
United Kingdom;Homeworking
Salary
Competitive
Start date
19 Jul 2024
Closing date
17 Aug 2024
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Job Details

The role can be based in Poland, UK, Romania, Hungary

Picture Yourself At Parexel:

The Senior Data Management Lead provides leadership and expertise in all aspects of Data Management. Develop and manage 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 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 Senior Data Management Lead can competently and independently lead large, complex projects and/or programs with little to no guidance from their Line Manager and/or Subject Matter Experts. Senior DMLs may act as a mentor for ADMLs, DMLs and other Senior DML peers.
May act as Project Leader for projects, involving only Global Data Operations services.

What You'll Do At Parexel:
  • Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications. Ensure the project/program is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill regulations (including oversight and maintenance of relevant data operations project documentation).
  • Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave).
  • Thorough knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system ( MyTrials, IVRS etc ) and Reporting functionality within the EDC system).
  • Thorough knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation.
  • Thorough knowledge of all activities during Study Maintenance and Database Lock. Review of metrics to determine risks and risk mitigation plans as required.
  • Effectively communicate to and manage internal project teams, external customers and third party vendors.
  • Effectively manage contracted project delivery. Highlight issues/risks to delivery and mitigate risks for both Parexel and the client, developing contingency plans for the project (or providing input to PL). Accountable for quality control of project deliverables and timely delivery of projects.
  • Ensure information entered into management systems is accurate and updated on a regular basis.
  • Review metrics reports regularly, determine the cause of any project overruns, track scope of ongoing work to identify and raise CIS in a timely manner.
  • Participate in cross functional meetings and drive initiatives, participate in Business Development and BID Defense meetings as required.
  • Prepare, participate in and follow up on audits/inspections.


Required skills, experience, and education:
  • Substantial data management experience in clinical research (CRO/Pharma/Biotech).
  • Proven record of leading project and program teams in a technical/programming or data processing environment.
  • Building and leading global (virtual) teams.
  • Strong understanding of cross functional activities.
  • Robust knowledge of ICH-GCP Guidelines and local regulatory requirements.
  • Bachelor’s degree in a science or industry related discipline.
  • Competent in written and oral English.
  • Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail.
  • Excellent interpersonal, oral and written communication skills.
  • Excellent presentation skills.
  • Strong customer focus, ability to interact professionally within a client organization.
  • Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.
  • Sound awareness of relevant regulations, including ICH-GCP, 21CFR11.
  • Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS.
  • Basic knowledge of SAS.

#LI-REMOTE

Company

parexel

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: 

Henry

 

 

Working With Heart™ - Christina's perspective:

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. 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
 Uxbridge
Middx
UB8 1LZ
GB
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