Clinical Data Management Technical Project Management Specialist

Accenture • Philadelphia, PA

4d

About The Position

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.

Requirements

• Minimum of 3 years of Project Management experience in the life sciences industry

Nice To Haves

• Bachelor’s Degree
• Clinical Data Management experience
• Experience performing hands on tasks or providing oversight for electronic data capture (EDC) development activities
• Experience using Microsoft Project/Project Server
• Pharmaceutical/Life Sciences industry experience
• Client Relationship Management experience in a drug development process (includes understanding and adherence to GCP/ICH and other regulatory guidance as appropriate)

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.

Benefits

• Accenture offers a market competitive suite of benefits including medical, dental, vision, life, and long-term disability coverage, a 401(k) plan, bonus opportunities, paid holidays, and paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level