What are the responsibilities and job description for the IT Implementation Project Manager position at Advanced Clinical?
OVERVIEW
We are currently searching for an IT Implementation Project Manager to join a well-known client’s team based in Waltham, MA. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
The Project Manager will play a key role in gathering requirements from subject matter experts (SMEs), translating business needs into structured IT requirements, and helping design and document business processes that align with system capabilities. This individual will serve as a bridge between business and IT teams, extracting operational knowledge from stakeholders and converting it into actionable technical documentation and implementation plans.
RESPONSIBILITIES
IT Implementation & Business Process Translation
• Lead project execution for technology implementation initiatives within TechOps, working closely with IT, Quality, QC, and other functional stakeholders
• Gather business requirements from subject matter experts across functional teams
• Translate business needs into structured IT requirements and technical documentation
• Extract operational knowledge from SMEs and convert it into system-ready specifications and workflows
• Support the design and documentation of future-state business processes aligned with system capabilities
• Coordinate closely with IT teams to ensure business requirements are accurately reflected in system configuration and implementation
• Build and maintain clear documentation of requirements, workflows, decisions, and deliverables
Project Management & Execution
• Develop and manage integrated project plans including timelines, milestones, dependencies, and deliverables
• Coordinate cross-functional project activities across Manufacturing, Quality, CMC, Supply Chain, and Regulatory teams
• Drive project execution by proactively identifying risks, removing roadblocks, and escalating issues when necessary
• Facilitate stakeholder meetings, working sessions, and governance reviews with project sponsors and leadership
• Manage project metrics, reporting, and dashboards to ensure transparency of progress and risks
• Support the RFP and vendor selection process when external partners or CDMOs are involved
Cross-Functional Collaboration & Stakeholder Engagement
• Partner closely with project sponsors and functional leaders to ensure alignment on project priorities and deliverables
• Work effectively in a matrixed organization across business, technical, and operational teams
• Identify appropriate SMEs to engage and facilitate collaboration between technical and business stakeholders
• Provide recommendations and guidance to project teams to support informed decision-making
Compliance & Quality Alignment
• Ensure project execution aligns with GxP compliance standards and regulatory expectations
• Support technology implementation projects that follow Computer System Validation (CSV) processes
• Collaborate with Quality teams to support change control processes, deviations, and CAPA where applicable
EXPERIENCE
• 10 years of project management experience in the pharmaceutical, biotech, or medical device industry
• Experience working with cross-functional teams including Manufacturing, CMC, Quality, Supply Chain, and Regulatory
• Prior experience supporting IT implementation or technology deployment projects in GxP environments preferred
• Experience participating in the implementation of GxP technology solutions following Computer System Validation (CSV) processes is strongly preferred
SKILLS, KNOWLEDGR & ABILITIES
• Strong project management and program coordination capabilities
• Demonstrated ability to gather requirements and translate business needs into technical solutions
• Experience documenting business processes and operational workflows
• Strong business change management experience supporting technology adoption
• Excellent written and verbal communication skills
• Exceptional attention to detail and documentation discipline
• Ability to proactively identify the right stakeholders and drive project progress
• Strong interpersonal skills with the ability to influence and collaborate across multiple teams
• Functional knowledge of GMP environments including:
• Analytical Development (AD)
• Supply Chain
• Quality event management (CAPA, Deviations, Change Controls) preferred
• Familiarity with GxP regulations, data integrity standards, and regulatory compliance requirements
• Experience with project management and collaboration tools such as Smartsheet, OneNote, and SharePoint
• Ability to manage competing priorities in a fast-paced and evolving environment
• Highly organized, proactive, and solution-oriented
EDUCATION
• Bachelor’s degree in science, engineering, healthcare, business administration, or related discipline
• Preferred: Project Management Professional (PMP) certification
#MSPTalent
35856
We are currently searching for an IT Implementation Project Manager to join a well-known client’s team based in Waltham, MA. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
The Project Manager will play a key role in gathering requirements from subject matter experts (SMEs), translating business needs into structured IT requirements, and helping design and document business processes that align with system capabilities. This individual will serve as a bridge between business and IT teams, extracting operational knowledge from stakeholders and converting it into actionable technical documentation and implementation plans.
RESPONSIBILITIES
IT Implementation & Business Process Translation
• Lead project execution for technology implementation initiatives within TechOps, working closely with IT, Quality, QC, and other functional stakeholders
• Gather business requirements from subject matter experts across functional teams
• Translate business needs into structured IT requirements and technical documentation
• Extract operational knowledge from SMEs and convert it into system-ready specifications and workflows
• Support the design and documentation of future-state business processes aligned with system capabilities
• Coordinate closely with IT teams to ensure business requirements are accurately reflected in system configuration and implementation
• Build and maintain clear documentation of requirements, workflows, decisions, and deliverables
Project Management & Execution
• Develop and manage integrated project plans including timelines, milestones, dependencies, and deliverables
• Coordinate cross-functional project activities across Manufacturing, Quality, CMC, Supply Chain, and Regulatory teams
• Drive project execution by proactively identifying risks, removing roadblocks, and escalating issues when necessary
• Facilitate stakeholder meetings, working sessions, and governance reviews with project sponsors and leadership
• Manage project metrics, reporting, and dashboards to ensure transparency of progress and risks
• Support the RFP and vendor selection process when external partners or CDMOs are involved
Cross-Functional Collaboration & Stakeholder Engagement
• Partner closely with project sponsors and functional leaders to ensure alignment on project priorities and deliverables
• Work effectively in a matrixed organization across business, technical, and operational teams
• Identify appropriate SMEs to engage and facilitate collaboration between technical and business stakeholders
• Provide recommendations and guidance to project teams to support informed decision-making
Compliance & Quality Alignment
• Ensure project execution aligns with GxP compliance standards and regulatory expectations
• Support technology implementation projects that follow Computer System Validation (CSV) processes
• Collaborate with Quality teams to support change control processes, deviations, and CAPA where applicable
EXPERIENCE
• 10 years of project management experience in the pharmaceutical, biotech, or medical device industry
• Experience working with cross-functional teams including Manufacturing, CMC, Quality, Supply Chain, and Regulatory
• Prior experience supporting IT implementation or technology deployment projects in GxP environments preferred
• Experience participating in the implementation of GxP technology solutions following Computer System Validation (CSV) processes is strongly preferred
SKILLS, KNOWLEDGR & ABILITIES
• Strong project management and program coordination capabilities
• Demonstrated ability to gather requirements and translate business needs into technical solutions
• Experience documenting business processes and operational workflows
• Strong business change management experience supporting technology adoption
• Excellent written and verbal communication skills
• Exceptional attention to detail and documentation discipline
• Ability to proactively identify the right stakeholders and drive project progress
• Strong interpersonal skills with the ability to influence and collaborate across multiple teams
• Functional knowledge of GMP environments including:
• Analytical Development (AD)
• Supply Chain
• Quality event management (CAPA, Deviations, Change Controls) preferred
• Familiarity with GxP regulations, data integrity standards, and regulatory compliance requirements
• Experience with project management and collaboration tools such as Smartsheet, OneNote, and SharePoint
• Ability to manage competing priorities in a fast-paced and evolving environment
• Highly organized, proactive, and solution-oriented
EDUCATION
• Bachelor’s degree in science, engineering, healthcare, business administration, or related discipline
• Preferred: Project Management Professional (PMP) certification
#MSPTalent
35856
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.