Clinical Data Management Project Manager
- Philadelphia, PA
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People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.
The Clinical Data Management Project Manager is responsible for developing program/project plans, estimates and for end-to-end program/project management, scoping and requirements through implementation and deployment of clinical trial systems in a highly regulated, standardized environment. Technical Project Manager proactively monitors and manages execution of deliverables and serves as a single point of contact for the client at a study level, accountable for predictable, timely, high quality delivery management across all functions.
- Determine needed deliverables, overall project schedule/timeline, critical path by deliverable, productivity improvements, overall risks and planning assumptions from study start through final archiving, including all change request management, ensuring documented processes are followed and customer expectations are understood and managed throughout.
- Ensure that all study project team members, as well as clients, are well-informed of the plan and committed; negotiate timelines, prioritization and resourcing as necessary. Regularly communicate across all functional areas and liaise with other shared service teams. Proactively manage/mitigate risks/issues, facilitating resolution and escalation if needed.
- 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.,).
- Proactively ensure that study project team complies with internal processes, quality reviews, SLAs, metrics, and timelines; Ensure all quality activities are executed and findings are addressed; Understand and work to the current SOPs and SPIs, ensuring deviations are documented appropriately.
- Work with all 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 CDM in achieving common goals. Identify process issues and/or improvement opportunities and propose plans to address.
- Act as internal advisor to peers and Managers related to performance, best practices and overall service delivery; Mentor new Project Managers; Identify efficiencies in process/technology, influence direction of group or project by leveraging own specialist knowledge; 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.
- Lead and serve on teams to optimize processes and use of CDM related technology to build a more efficient organization. Propose new and revise current procedures as appropriate Encourage practical applications of new ideas.
- Maintain awareness of developments in technology external to unit in order to identify areas for opportunity and or provide input to continuous improvement efforts (e.g. SCDM, CDISC, InForm activities).
- Minimum of 2 years of project management experience in clinical data management, regulatory and/or pharmacovigilance using project management software/enterprise system
- Bachelor's degree
- Experience performing hands on tasks or providing oversight for EDC development activities (InForm preferred, other platforms acceptable ie RAVE, Home grown)
- Client relationship management experience in a drug development process (includes understanding and adherence to GCP/ICH and other regulatory guidance as appropriate)
- Experience with Microsoft Project or Microsoft Project Server
- Working knowledge of software development life cycle, and relational database concepts
Professional Skill Requirements
- Excellent communication (written and oral,) organizational, interpersonal and time-management skills
- Proven ability to build, manage and foster a team-oriented environment using leadership and management skills
- Proven ability to work creatively and analytically in a problem-solving environment
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture.
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Requesting An Accommodation
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Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
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