UnitedHealth Group is an innovative leader in the health and well-being industry, serving more than 55 million Americans.

Through our family of companies, we contribute outstanding clinical insight with consumer-friendly services and advanced technology to help people achieve optimal health.

i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research.

The company demonstrates leadership and innovation by leveraging world-class process design and six-sigma quality, affording clients the ability to maximize efficiencies and exceed customer expectations.

As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Statprobe can provide.

i3 Statprobe currently has an immediate need for a Sr. Clinical Data Manager to work in our Indianapolis, IN office.

The Sr. Clinical Data Manager leads data management activities for projects involving multiple and/or complex clinical studies, including global studies.

They are able to work without close supervision and can coordinate the activities of other junior staff members.

Responsibilities: Assumes overall responsibility for the successful execution of the data management projects assigned to themLead DM with minimal supervision for several midsize to complex projects/partnershipsWrites, updates/reviews and approves all required trial data management documentation, documents and presents CRF completion guidelines at investigator meetingsPerforms any data management activities related to projects, as neededProvides leadership and may supervise/train Data Management staff assigned to work on their projects, including Clinical Data Coordinators and other Data Mangers, supports training of project staffMonitors the progress of all data management activities for the project to ensure that project timelines are metDirects activities associated with data integration and dataMonitors the quality and coordinates all data management QC activities for the projectEstablishes and coordinates the timely completion of the database lock proceduresUnderstands and follows the process if the database needs to be unlockedMonitors the data management process for the project to ensure that work is proceeding in an efficient mannerEstablishes timelines to perform an audit and oversees activities of audit teamEnsures adequate preparation for internal and external database and data management audits, can respond knowledgeably and confidently to issues or questions that arise during auditsServes as Data Management contact with sponsor managing their expectations, noting and responding to out-of-scope workLiaise with clients on limited basis and produce trial progress reportsSome business development work may be required, such as input to proposals and client presentationsRemain informed of new developments in data management that are relevant to the industryParticipate in the development of Standard Operating Procedures (SOPs) and guidelinesProvide feedback to team members and supervisors (if applicable) on individual performance and contributions to the overall team effort in a constructive mannerSome line management activities may be required with the ability to guide and counsel direct reports/mentees on their career developmentWork effectively with international peers and sponsors, as neededAssist in directing global data management projects to ensure the seamless provision of servicesHave thorough understanding of data management budgets and can communicate out of scope requests to the project manager Qualifications BA / BS Degree in life sciences, or an equivalent combination of education and work experienceExtensive experience in leading data management activities for multiple mid size to large/complex studiesPrevious team leadership experience or strong leadership skillsThorough knowledge of applicable regulatory rules and guidelines; eg ICH, GCPDemonstrated proficiency in the data management processExcellent interpersonal and communication skills (written and verbal) together with presentation skillsStrong attention to detail and problem solving skillsAbility to work in a fast-paced, teamoriented environmentProficient in the use of the clinical data management systems used at i3 Statprobe, understands the structure of an electronic medical dictionary and how auto encoding worksPossesses a positive attitude and works well within onsite teams and off site teams Basic Programming Knowledge (for example SQL) Diversity creates a healthier atmosphere: equal opportunity employer M/F/D/VUnitedHealth Group is a drug-free workplace.

Candidates are required to pass a drug test before beginning employment.

In addition, employees in certain positions are subject to random drug testing.

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