Location: New York, NY
Duration: 4 Months +
Basic Qualifications:
• 4 year college degree in Business, MIS or biological sciences
• 7-10+ years of experience working with clinical trials in a data management-related role, or equivalent combination of education and experience
• 3-4+ years of experience working understanding of data management plans / customer specifications for data entry screens, edit checks, custom reports and data integrations
Additional Preferred Skill Requirements:
• Knowledge of computer usage in a web-based environment
• Ability to think logically to solve complex problems
• Excellent verbal and written communication skills
• Project management skills
• Operational Excellence or Six Sigma experience
• Solid analytical and technical skills
• Excellent organizational and time management skills
• Ability to handle multiple projects with rapidly changing priorities and deadlines
• Self-motivated, able to assume responsibility and work autonomously in a professional manner
• Commitment to quality and attention to detail
• Strong collaboration and team building skills
Responsibilities:
• Manage the day to day relationship with the Therapeutic Area and respective Data management teams.
Manage the overall status of CDM, SDTM, and DBP study statuses (e.g. study build, data entry, data cleaning) for assigned studies (paper and / or EDC) in coordination with Project Data Manager and forecasted studies
• Work closely with Therapeutic Area Project Data Manager(s) to ensure tight collaboration of the activities completed by the Accenture team during Study Design offshore and onshore
• Facilitate communications between offshore and onshore delivery teams and offshore Therapeutic Project leads.
• Assist Therapeutic Area Project Data Manager(s) in resolving questions, issues, risks raised by the offshore team during the operations phase of the trial
• Support day-to-day interaction with third party vendors such as CROs and central labs to enable tight integration and timely delivery of data in the appropriate format
• Work closely with Therapeutic Area to manage and assign work to Accenture offshore staff and closely tie workload forecasts to workforce requirements.
• Proactively communicate outstanding issues to Therapeutic Data Management teams in Portfolio and Project Review meetings on an ongoing basis and especially as the team approaches database lock or key deliverables
• Work closely with the offshore team to obtain status, manage timelines, resolve issues, and mitigate risk
• Support communication and integration between onshore and offshore activities, including support (e.g. tracking and management ) of relevant service levels in ongoing interactions with the Delivery leads
• Create and distribute study level and overall status reports to support governance model(s).
• Support Therapeutic Area through work initiation process (Work Orders) by understanding business scope, protocol, and demands for resource management planning.
