Data Management Opportunities at Parexel
Discover Parexel, a premier service provider for the global pharmaceutical industry that can offer you the opportunity to make a profound difference in millions of lives. You'll be immersed in diverse projects that keep you challenged every day, as well as surrounded by colleagues who share your passion and dedication. Bring life-saving treatments to the world with a Data Management job at Parexel. You'll collaborate with a diverse multi-functional team and use an array of technologies on global projects. In addition, our fast-paced environment will give you an opportunity to learn something new every day while you support the accurate collection, organization and analysis of clinical data on small and large studies. Achieve your personal and professional goals with a career in Data Management at Parexel. Our advancement opportunities, individual development and professional growth programs will inspire you to be your best each and every day. If you're a motivated team player, eager to make an impact within Parexel and in the world, join us.
(Senior) Data Management Lead (UK, Poland, Romania, Ireland)Job ID 54144BR Poland - Any Region - Home Based
The Data Management Lead provides leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming. The Data Management Lead manages the delivery of all relevant data operations activities from database setup through database lock and data transfers.
General areas of responsibility include: coordination of the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.
May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned.
- 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.
o Building and leading global (virtual) teams.
o Ability to work effectively with and motivate virtual teams.
o Ability to negotiate and influence in order to achieve mutually beneficial results.
o Proven problem solving skills.
o Strong communication skills with a diplomatic approach.
o Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail.Personal skills that include:
o Excellent interpersonal, oral and written communication skills.
o Ability to gain trust and confidence with a variety of clients as well as within Parexel.
o Excellent learning ability.
o Excellent presentation skills.
o Ability to travel as required.
Business / Operational skills that include:
o Strong customer focus, ability to interact professionally within a client organization.
o Understanding of Parexel project 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.
o Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.
o Sound awareness of relevant regulations, including ICH-GCP, 21CRF11.
o Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS.
o Basic knowledge of SAS.
Knowledge and Experience:
- Substantial experience in clinical research
- Proven record of leading project and program teams in a technical/programming or data processing environment
- Strong understanding of cross functional activities
- Strong customer service focus
- Robust knowledge of ICH-GCP Guidelines and local regulatory requirements
- Bachelor’s degree and / or other qualifications in a science or industry related discipline
- Competent in written and oral English
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