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).
Must manage time, and understand financials, maintain focus on quality, balancing deadlines with ensuring high quality output
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.
Ensure interdependencies are understood, anticipate potential barriers or issues, and put plan in place with appropriate countermeasures
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.
Prepare, participate in and follow up on audits / inspections.
Participate 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.
4-5 years of DM experiences.