The Clinical Data Management Technical Project Management Specialist is responsible for developing program/project plans and estimates and for end to end program/project management, scoping and requirements through implementation and deployment. The Clinical Data Management Technical Project Management Specialist proactively monitors and manages execution of deliverables. They serve as a single point of contact for the MACH1 client at a study level, accountable for predictable, timely, high quality delivery management across all MACH1 functions.
Key Responsibilities:
Develop an end-to-end study project plan and estimates through collaborations with MACH1 study project team members and negotiations with the client from protocol approval to final archiving
Determine needed deliverables, overall project schedule/timeline, critical path by deliverable, productivity improvements, overall risks and planning assumptions
Drive/evaluate estimates by deliverable and work with teams to optimize overall estimates
Ensure that all study project team members as well as clients are well-informed of the plan and committed to support
Proactively manage and monitor execution of deliverables and status in an assertive manner
Closely monitor the project progress and proactively identify risks/issues an determine impact of risks/issues and coordinate necessary actions
Escalate issues to functional team leads/management which cannot be resolved at the study level
Ensure cross functional team project issue, risk, and/or conflict resolution is occurring
Manage critical path, dependencies, contingency, and scope/change requests
Eliminate road blocks, proactively, in the critical path to help ensure successful delivery of the solution
Ensure the customer expectations are understood and managed
As a single point of contact, report and manage overall study project status to the client
Ensure proper and regular communication across all functional team members for a study project
Liaise with other shared service teams (ie data vendors, forms production) to ensure all necessary components for accurate and complete study design are in order
Validate that proper deliverable and phase stage containment is occurring (e.g., signoffs are scheduled and completed, dependent deliverables are completed, necessary client approvals are obtained, a study member who takes the next course of action is properly informed/cued, etc.,)
Manage all Change Requests, validate all impacts, and ensure that all study project members are appropriately consulted and informed.
Ensure all quality activities are executed and findings are addressed
Ensure proactively that a study project team is in compliance with internal processes, quality reviews, SLAs, metrics, and timelines
Identify process issues and/or improvement opportunities and develop proposals to address improvement opportunities as needed
Work with all other onshore and offshore therapeutic area and shared service roles to promote consistent operations, efficient use of resources and sharing knowledge/best practices. Support management of Clinical Data Management (CDM) in achieving common goals.
Promote teamwork within assigned therapeutic areas. Find common ground, communicate and proactively share information.
Interact with Clinical/Clinical Data Management teams to understand and meet their needs.
Understand and work to the current divisional / departmental SOPs and SPIs, ensuring deviations are documented appropriately. Propose new and revise current procedures as appropriate.
Lead and serve on teams to optimize processes and use of CDM related technology to build a more efficient organization. Encourage practical applications of new ideas.
Maintain awareness of developments in technology external to unit in order to provide input to continuous improvement efforts (e.g. SCDM (Society for Clinical Data Management), CDISC activities).
May be accountable for leading software validation efforts and/or writing and executing scripts for software validation
May represent CDM on non-operational Client teams
Represent Accenture Services at all times in client interactions by maintaining professional demeanor and conduct consistent with Accenture Values and Code of Ethics.
Performs complex tasks and participates in complex cross-area/function activities.
Manages effective internal/external client relationships within own area of responsibility and builds client relationships in the wider group or unit.