MillenniumSoft Inc

Clinical Operations

• Working within the Global Clinical Development (GCD) organization, the Clinical Project Manager is responsible for clinical trial management of multiple studies and may be subject matter expert for group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by GCD or Contract Research Organizations (CRO).
• This role serves as the project lead for studies of moderate to high complexity from protocol development through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National and Local Regulations.
• Reports to and collaborates with Clinical Portfolio Management to review business requests and evaluate or develop early plans and concepts for optimal study execution.
• Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
• Serves as a Clinical Project Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team
• Oversees/leads study-specific study management resources
• Develops and manages group of studies for an entire business unit or large development program
• Provides critical thinking and leadership when issues arise during execution of clinical studies.
• Leads or contributes to continuous improvement activities/initiatives.
• Manages relationships with sites/PIs. other study related vendors, including CRO’s.
• Intermediate knowledge, of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed.
• Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path, and other key deliverables including efficiency and effectiveness of plans and staff.
• Adapts work package deliverables based on study scale and complexity.
• Creates aggressive but achievable resource and budget forecasts and timelines.
• Interacts with both Internal and External contacts, providing direction to the GCD cross functional team members and vendors (if applicable) regarding the technical, protocol-specific, and operational aspects of assigned studies.
• Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost effective timely delivery of the project including escalation if needed
• Plans and maintains high quality standards to meet compliance requirements.
• Ability to travel approximately 30% of the time, US and Internationally. All other duties as assigned.

Clinical Project Manager – East Coast Hours

Software Engineer

• Follows company software development lifecycle to design, code, configure, test, debug, and document system and application programs
• Assists in preparing technical design specifications based on functional requirements and analysis documents
• Reviews functional requirements, analysis and design documents and provides feedback
• Collaborates with other development staff to achieve quality and consistency
• Participates in architecture, design and code reviews
• Develops and maintains operational and system level documentation

Cherwell Developer

Consultant

• Assess the impact of the change on stakeholders, including identifying and addressing potential resistance to change
• Manage the change process to ensure a successful implementation, including developing and executing a change management plan, tracking progress, and identifying and mitigating any risks or challenges
• Ensure new systems, processes, and technologies are successfully adopted by the organization through developing and delivering training and communication plans
• Monitor and evaluate the effectiveness of change management initiatives, including collaboration with other departments to ensure successful change management
• Facilitate change management workshops and meetings, including training new team members

Change Management Consultant – Healthcare Industry

Salesforce Consultant

• Set and implement change management strategy
• Work with stakeholders to assess the impact of the change
• Develop a communication and training plan
• Manage the change process to ensure successful implementations
• Monitor and evaluate the effectiveness of change management initiatives
• Facilitate change management workshops and meetings

Change Management Consultant – Salesforce, Change Management Certification Required

Communications

• Create and maintain audience-based messaging and presentations for a large portfolio of transformation initiatives, translating key takeaways and connecting dots to formulate a compelling story for executive audiences
• Lead, shape and manage change management strategy planning and execution at both strategic and tactical levels
• Ability to shape and indirectly lead networks of change champions to execute change and communications plans
• Define metrics for success, revisit them regularly, and evaluate progress
• Establish rapport with internal and external stakeholders
• Quickly adapt and maintain focus in a rapidly changing environment, producing flexible plans to meet changing business needs
• Serve as an experienced change agent, influencing, building consensus, and fostering trust across teams to accelerate outcomes
• Create and implement communication strategies that align with the organization’s goals and values, ensuring consistent messaging across various channels
• Create content (e.g., presentations, emails, talking points, FAQs, intranet pages, etc.) for internal audiences, ensuring the message is clear, accurate and engaging
• Possess an outcome-driven mindset, converting strategic change and communications plans into actions, driving projects to completion, and paying attention to details to deliver outcomes
• Excel as a communicator with strong presentation skills and compelling storytelling abilities, able to explain complex topics and convince all levels of stakeholders to take action
• Exhibit well-rounded interpersonal skills, working in a highly cross-functional environment, developing strong relationships, and influencing stakeholders
• Create and deliver stakeholder and executive-level initiative updates, reviews, and impact analyses presentations
• Timely completion of internal company documentation
• Timely completion of any Company or Department required training
• Mentor others on best practices
• Performs other duties as assigned

Clinical Project Manager – East Coast Hours

Cherwell Developer

Change Management Consultant – Healthcare Industry

Change Management Consultant – Salesforce, Change Management Certification Required

Change Management, Strategic Communications Transformation Manager