Associate Data Management Lead

Job Description

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 electronic source data capture systems (e.g. ClinBase) Thorough knowledge of the eClinical suite and additional tools and systems that can be integratedwith 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. Hold team meetings on a regular basis. Participate in client, investigator and team meetings.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. 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.QualificationsLeadership -0 Building and leading global (virtual) teamso Ability to work effectively with and motivate virtual teamso Ability to negotiate and influence in order to achieve mutually beneficial resultso Proven problem solving skillso Strong communication skills with a diplomatic approacho Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detailo Effective time management in order to meet objectivesPersonal skills that include:o Excellent interpersonal, oral and written communication skillso Ability to gain trust and confidence with a variety of clients as well as within PAREXELo Excellent learning abilityo Managerial courage, resilience, and ability to adjust to a rapidly changing environmento Excellent presentation skillso Work with integrityo Ability to travel as requiredBusiness / Operational skills that include:o Strong customer focus, ability to interact professionally within a client organizationo 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 Commitment to qualityo Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standardso Sound awareness of relevant regulations, including ICH-GCP, 21CRF11o Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRSo Basic knowledge of SASBachelor s degree and / or other qualifications in a science or industry related disciplineCompetent in written and oral English.,

Keyskills :
data managementproblem solvingcustomer focusquality controltechnical skillstime managementenvironmental impact assessmentrisk mitigationproject teams