PURPOSE
Lead assigned
Digital Patient Unit project(s) of varying complexity, department
responsibilities and company-wide initiatives. Ensure all work is
conducted in accordance with SOPs, policies and practices, ICH/GCP,
patient privacy protection and applicable regulatory requirements.
RESPONSIBILITIES
Lead
in the establishment and maintenance of all project documentation
including all files, records and reports according to the scope of work
and Quintiles/customer SOPs
Lead the development, programming and
quality control (QC) of surveys/questionnaires (as required) using
Digital Patient Unit survey software tools
Lead the coordination
and tracking of all data, department metrics, communications, documents,
materials and supplies for assigned projects
Support the updating
and maintenance of internal systems, databases, tracking tools,
timelines and project plans with project specific information
Prepare presentation materials and coordinate logistics for meetings (internal/external)
Complete required corporate training courses/initiatives and department administration items on schedule with high quality
Lead
the management of Digital Patient Unit project deliverables by ensuring
quality completion of project milestones on schedule within defined
study scope-of-work and budget
Lead project specific communications
effectively with customers, internal project teams, study sites and
patients (when appropriate)
Lead project plan development,
generation of study specific materials, risk mitigation planning, study
kick-off and team meetings, and issue escalation to Sr. Oversight. May
also act as a back up contact for internal project team members to
ensure communication is maintained and reporting schedules are adhered
to.
Identify and escalate discrepancies with defined solutions for resolution in project tracking data
Rapidly and accurately access the viability of Digital Patient Unit solutions for addition into Quintiles proposal strategies
Participate
and contribute to Digital Patient Unit proposal and request for
information responses. May also participate in bid defense processes.
May
triage responsibilities/tasks to other project staff and be accountable
for Digital Patient Unit team members assigned to support project
outputs.
Advocate for Digital Patient Unit solutions and the
patient perspective for inclusion within strategy discussions for
customers (internal and external). May include presentation on Digital
Patient Unit capabilities, training, etc.
Coordinate and lead
opportunities with other departments outside of Digital Patient Unit to
identify and consolidate processes in support of project delivery and
DPU departmental initiatives
Responsible to train more junior project support staff. May also be assigned as a project support staff mentor.
May perform other tasks as assigned by the Digital Patient Unit team in support of project delivery or departmental efforts
May also be assigned to perform the following technical responsibilities in support of delivery projects and IT systems/tools:
Lead the development of
the technical requirements and conduct programming (or source this
capability from an external vendor) in support of delivery
Coordinate technical development efforts with vendors (including sourcing vendors, if needed)
Develop
technical specifications, technical program management plans and
requirements for completion of program design and setup
Serve as primary technical contact for delivery team with accountability for clear communication and milestone adherence
Lead
technical problem solving and resolution efforts to include risk
mitigation, rapid IT solutions and contingency planning in conjunction
with the delivery team to ensure timelines are met
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