Project Manager/Business Analyst

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Job description

Project Manager/Business Analyst

THIRD PARTY AGENCIES, SUBCONTRACTORS, AND RECRUITERS NEED NOT APPLY. Applicants received from firms will not be considered. Subcontracting is not available for this position.

TITLE : Project Manager / Business Analyst (PM/BA)

Project Manager / Business Analyst for Capabilities will be responsible for planning, managing, tracking and reporting of all project activities related to key capability builds. In this role, the PM/BA will be assisting with aiding the compliance department develop and augmenting / improving the existing the overall compliance program. The position will work with key compliance 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. The position will also work with the ePMO to follow and meet key project management processes and reporting requirements.

REQUIRED SKILLS :

• 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

DESIRED SKILLS :

• Experience in Life Sciences Compliance


• Smartsheet experience

RESPONSIBILITIES :

• 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.

- provided by Dice