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 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. 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) 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 o Effective time management in order to meet objectives 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 Managerial courage, resilience, and ability to adjust to a rapidly changing environment o Excellent presentation skills o Work with integrity 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 Commitment to quality 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 Bachelors degree and / or other qualifications in a science or industry related discipline Competent in written and oral English.