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- 4+ years working in a regulated pharmaceutical organization, CRO or FSP
- 10+ years as a project manager and business analyst
- Experience managing and implementing life sciences Compliance systems or projects such as:
- Experience with One Trust application
- Developing a Governance, Risk and Compliance (GRC) program (Lextegrity) Experience with transparency reporting (MediSpend)
- Risk Management including vendor / 3rd party risk management
- Global monitoring Investigator and incident management
- Consent Management Website Cookie Management
- Good Clinical Practice and Part 11
- Experience partnering with business leads to evaluate and document business requirements and use cases
- Experience managing successful projects including project dashboard/status updates, stakeholder management, vendor management, timeline management, and tracking of key risks, issues, activities, and deliverables
- Leadership of business capability development and IT system implementation projects
- Ability to communicate effectively with stakeholders at all levels of a matrix organization
- Ability to work in a collaborative team environment; willing to pitch in to achieve goals and maintain relationships with business leads, stakeholders, business users, technical team, validation, quality, and vendor resources
- Ability to work independently and with minimal supervision
- Demonstrated ability to establish and meet priorities and deadlines
- Experience with timeline management and resource / capacity management
- English as a first language or excellent written and spoken English fluency
- Minimum Degree Required: Bachelor's Degree
- Experience in Life Sciences Compliance
- Smartsheet experience
- Partner closely with client's Compliance Team and all key stakeholders to develop the strategy and assist in the gathering requirements for the strategy, developing a resource and overall plan to enable the strategy and help with the implementation of some of the key compliance projects in the Capabilities Portfolio.
- Activities will include but not limited to:
- Assist in the development of the overall compliance strategy
- Support change management activities related to the communication of this strategy
- Develop an overall resource and project plans for the overall portfolio
- Support develop of program requirements to support package selection efforts
- Support Client's PFI / RFP process as needed
- Develop, define and document business processes that align with Client's Compliance SOPs
- Develop, define and document operational model and requirements
- Facilitate and document IT architecture design Support IT security / infrastructure review for new IT systems
- Plan, manage, track and report on full system implementation lifecycle Implement organizational change management approach, capturing and rolling out end user training and communication
- Oversee and drive all project team management and controls in accordance with Client's Capabilities methodology (e.g., project planning, scope, issue and risk management, decisions tracking, meeting coordination and minutes, etc.)
- Establish post implementation support processes Ensuring long-term support models and roles are identified and trained (e.g., system administration, system owner, process owner, etc.)
- Bring expertise to bear in guiding business users through the capability build and managing to project success criteria through project dashboard/status updates, project plan management, stakeholder management, vendor management, schedule management, and tracking of key risks, issues, activities, and deliverables.
- Responsible for the creation business process maps, business procedure documentation that capture the business, technical and operational requirements of the project.
- Manage the development of end user training and communication materials required to evangelize the implementation the capability.
- ID: #23756336
- State: Massachusetts Cambridge 02138 Cambridge USA
- City: Cambridge
- Salary: USD TBD TBD
- Job type: Contract
- Showed: 2021-12-02
- Deadline: 2022-01-31
- Category: Et cetera