Responsible for project management of all the data management services for the assigned projects. Ensures the contracted Data Management activities for projects are carried out by the Company in accordance with the executed contract and the Sponsor’s expectations.
Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
Coordinate the work of the assigned Data Management/Data Operations team
Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
Provides project specific training to internal and external audiences as required
Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
Plan, manages and requests resources for assigned projects
Develop and maintain project plans, specifications and documentation in line with SOP requirements
Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date
Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
Plans for and creates necessary documentation to support internal and external audits; participates in such audits
Trains and mentors data management staff
Prepares input for, and participates in proposal bid defense meetings
Maintains proficiency in Data Management systems and processes through regular training
Performs other work related duties as assigned. Minimal travel may be required (up to 25%)
BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
Clinical data management experience or an equivalent combination of education and experience.
Experience of Clinical Data Management practices and relational database management software systems.
Strong project management skills and knowledge of project management methodologies
Demonstrated staff leadership skills.
Contract Research Organization (CRO) experience preferred.
Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. Effective oral and written communication skills.
Strong presentation skills
Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
This Job Excludes CO Applicants
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
:North America - USA-Virginia-Home-Based
:North America - US Home-Based, North America - CAN-Home-Based
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