Job Description - Principal Project Data Manager (21008912)
Principal Project Data Manager-(21008912)
Responsible for project management of all the data management services for the assigned projects/program. Ensures the contracted Data Management for projects are carried out by the Company in accordance with the executed contract and the Sponsor’s expectations. The scope will include projects that are large and/or complex and/or with particular challenge. Likely to oversee program(s) of projects for same Sponsor. May supervise DM team members for a specific program of studies. Duties include primary liaison with customers, vendors and/or senior management.
On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project 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
May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM)
Development and adherence to standards across a program of projects
Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program
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/program 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
Supports the management of resources on assigned projects/programs
Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment
Develops and maintains project plans, specifications and documentation in line with SOP requirements
Maintains documentation on an ongoing basis and ensures that all TMF filing is correct 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
May participate in or lead Data Management/Operations process improvement initiatives
May supervise/line manage others
Participates in the development of departmental technologies, SOPs, processes, and procedures
Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training.
Prepares input for, and participates in proposal bid defense meetings
Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business
May represent Data Management/Data Operations in company-wide initiatives
Performs other work related duties as assigned. Minimal travel may be required (up to 25%)
Progressively responsible work experience in line with the expectations of the role.
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.
Years of experience required: Minimum of eight (8) years of data management experience, including minimum of four (4) years of managing data management projects.
Extensive Clinical data management experience or an equivalent combination of education and experience.
Extensive experience in 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.
Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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