Data Management Lead II (Poland, UK, Romania, Hungary, Spain)
Parexel International Corporation
The role can be based in Poland, UK, Romania, Hungary, Spain
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.
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.
Knowledge and Experience:
Substantial experience in clinical research (CRO/Pharma/Biotech)
Proven record of leading project and program teams in a technical/programming or data processing environment.
Strong understanding of cross functional activities.
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.
Leadership skills that include:
Building and leading global (virtual) teams.
Ability to negotiate and influence in order to achieve mutually beneficial results.
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.
Business / Operational skills that include:
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.
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