Data Management Lead I, FSP (South Africa)

Parexel International Corporation

South Africa - Any Region - Home Based

Job Purpose:

The Data Management Lead I (FSP) has overall accountability for the execution of the Data Management FSP project strategy from database setup through database lock and the Data Management technology set-up for the project.

Can competently and independently lead large, complex projects and/or programs.

Provides leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming.

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. May cover for the Clinical Operations Lead, if appropriately trained in the corresponding tasks.

Main responsibilities: 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, SOP's, ICH and/or other guidelines to fulfill regulations. Must manage time, and understand financials, maintain focus on quality, balancing deadlines with ensuring high quality output maintenance of relevant data operations project documentation. Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave). In-Depth knowledge of electronic source data capture systems (e.g. ClinBase). 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. Comprehensive 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. Hold team meetings on a regular basis. Participate in client, investigator and team meetings. Ensure interdependencies are understood, anticipate potential barriers or issues, and put plan in place with appropriate countermeasures. Oversee 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. Manage appropriate project level resourcing of staff and staff assignments. Identify and request staff necessary for the project team. 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. Engage in meeting with Business Development / PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client. Collaboration with the Clinical team to review the ClinBase setup performed by the pharmacy, safety Laboratory team and Clinical Database Designer. QualificationsIdeal candidate will possess: Bachelor’s degree and / or other qualifications in a science or industry related discipline. Competent in written and oral English. Substantial experience in clinical research. Proven record of leading project and program teams in a technical/programming or data processing environment. Substantial understanding of cross functional activities. Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOP's and study specific procedures. Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards. Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS. Basic knowledge of SAS. Building and leading global (virtual) teams. Ability to work effectively with and motivate virtual teams. Strong communication skills with a diplomatic approach. Ability to conduct root cause analysis in business problem solving and process improvement development. Exemplary presentation skills. Strong customer focus, ability to interact professionally within a client organization. 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.


2022-04-14 00:05:29


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