PCRU Process and Procedure Project Manager

4 weeks ago


Groton, Connecticut, United States Innova Solutions Full time

The PCRU Process and Procedure Project Manager is a critical role at Innova Solutions, responsible for the management of procedural documentation across both the New Haven and Brussels sites. This position requires a strong understanding of corporate compliance and inspection readiness objectives, as well as the ability to maintain procedural documentation in a manner that supports these goals.

This role is responsible for managing the lifecycle of procedural documents, including development, revision, harmonization, implementation, and maintenance. The PCRU Process and Procedure Project Manager will work closely with subject matter experts to identify changes or improvements required to procedural documentation based on regulatory changes, audit/inspection findings, business needs, or changes in industry standards.

The ideal candidate will have a Bachelor's Degree and 2+ years of experience in procedural document management. They will also have a strong enthusiasm for process improvement and document design, as well as the ability to collaborate with peers and work proactively with training representatives to support the roll-out of new and revised processes.

Key Responsibilities:

  • Manage the lifecycle of procedural documents across both the New Haven and Brussels sites.
  • Maintain procedural documentation in a manner that supports corporate compliance and inspection readiness objectives.
  • Work closely with subject matter experts to identify changes or improvements required to procedural documentation.
  • Collaborate with peers to ensure the PCRU CMCDs meet regulatory requirements and are designed with operational effectiveness in mind.
  • Manage the CMCD lifecycle, including the approval cycle, posting cycle, and training cycle.

Requirements:

  • Bachelor's Degree.
  • 2+ years of experience in procedural document management.
  • Enthusiasm for process improvement and document design.
  • Ability to collaborate with peers.
  • Knowledge of clinical trial operational processes and supporting systems and tools.
  • Familiarity with project management tools.
  • Strong written and verbal communication skills.
  • Experience working with 21 CFR part 11 (or equivalent) compliant document management/electronic signature software systems.

Benefits:

Innova Solutions offers a comprehensive benefits package, including medical and pharmacy coverage, dental and vision insurance, 401(k), health savings account (HSA), flexible spending account (FSA), life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick time, and other types of paid leaves (as required by law). We are an equal opportunity employer and prohibit any kind of unlawful discrimination and harassment.



  • Groton, Connecticut, United States Amtrak Full time

    Job Summary:We are seeking a highly skilled Project Controls Manager to join our team at Amtrak. As a key member of our project management team, you will be responsible for applying scheduling and progress measurement tools, systems, and work processes to drive effective schedule monitoring and control, project progress measurement, and associated...


  • Groton, Connecticut, United States General Dynamics Electric Boat Full time

    Program Representative IT Project Manager Job Summary General Dynamics Electric Boat is seeking a highly motivated Program Representative IT Project Manager to join the EBIT Project and Portfolio Management Office PMO team. The successful candidate will be responsible for budget schedule process and oversight for projects within the Application software...

  • Project Manager

    4 weeks ago


    Groton, Connecticut, United States Doncasters Group Full time

    At Doncasters Group, we're looking for a skilled Project Manager to join our team. As a Project Manager, you'll be responsible for planning and allocating resources, preparing budgets, and monitoring progress throughout the project lifecycle.The ideal candidate will have a degree in an engineering discipline or equivalent years of work experience in a...


  • Groton, Connecticut, United States National Guard Employment Network Full time

    Job DescriptionAt National Guard Employment Network, we are seeking a highly skilled Project Manager to join our team. As a Project Manager, you will be responsible for overseeing and managing operational aspects of ongoing improvement projects, acting as a liaison between Project Team and Line Management.Key ResponsibilitiesManage project budgets, track...


  • Groton, Connecticut, United States VetJobs Full time

    At VetJobs, we are committed to helping our nation's heroes find meaningful employment opportunities. As a valued member of our team, you will play a critical role in supporting our mission.The Head of Legal Project Management position is a unique opportunity to leverage your skills and experience in project management to drive success in our legal...


  • Groton, Connecticut, United States Lorven Technologies Full time

    The Data Center/Cloud Project Manager is responsible for leading the initial major stages in identifying alternatives and options for future computing needs, including sunset and migration strategy, architecture and capacity planning, and capital and operating expense planning.This role will bring forth a deep understanding and evaluation of the needs and...


  • Groton, Connecticut, United States LaBine and Associates Full time

    Job OverviewLaBine and Associates is seeking a highly skilled ISSO to join our dynamic team in Groton, CT. As an ISSO, you will play a critical role in ensuring the security and functionality of our systems.Key Responsibilities:Develop and process Risk Management Framework documentation to secure Approval to Operate for Collateral and SAP Information...


  • Groton, Connecticut, United States General Dynamics Full time

    Job Summary:The Operations Supervisor - Electrical Division will be responsible for managing the daily activities of a team of hourly Outside Electricians and Electronics Mechanics. This includes providing daily direction and technical assistance, managing crew safety, quality, cost, and schedule performance within established goals, and promoting and...


  • Groton, Connecticut, United States General Dynamics Full time

    Job Summary: We are seeking a highly skilled and experienced Senior Construction Manager to join our team at General Dynamics Electric Boat. The successful candidate will be responsible for managing the daily activities of 2-4 supervisors, providing daily direction and technical assistance, and ensuring that all nuclear procedures and safety requirements are...


  • Groton, Connecticut, United States Henny Penny Full time

    Job SummaryWe are seeking a highly motivated and experienced Store Operations Manager to join our team at Henny Penny. As a key member of our store management team, you will be responsible for leading the day-to-day operations of our store, ensuring exceptional customer service, and driving sales growth.Key Responsibilities:Lead and manage the store team to...


  • Groton, Connecticut, United States Trexon Full time

    Job SummaryWe are seeking a highly skilled Design and Manufacturing Engineer to join our team at Trexon. As a key member of our USA region, you will play a pivotal role in leading our endeavors in designing, manufacturing, and deploying customized subsea connectivity assemblies.About the RoleAs our Design and Manufacturing Engineer, you will be responsible...


  • Groton, Connecticut, United States General Dynamics Electric Boat Full time

    Job SummaryWe are seeking a highly skilled Logistics Program Representative to join our team at General Dynamics Electric Boat.Key ResponsibilitiesCoordinate and track logistics products, including maintenance planning, supply support, and configuration management.Develop and implement logistics strategies to support program objectives.Collaborate with...


  • Groton, Connecticut, United States GP Strategies Full time

    GP Strategies is seeking a skilled Training Development Specialist to support a large client in Groton, CT. This full-time, benefitted role involves building effective working relationships with Operations Management and client Subject Matter Experts to gather content information and feedback.The ideal candidate will have a solid understanding of ISD and...

  • Store Manager

    4 weeks ago


    Groton, Connecticut, United States Henny Penny Full time

    Job DescriptionAt Henny Penny, we are seeking a highly skilled and experienced General Manager to lead our Groton Store 24 location. As a key member of our team, you will be responsible for maximizing store profitability through effective team development, operational excellence, sales building, and financial performance management.Key...

  • Store Manager

    4 weeks ago


    Groton, Connecticut, United States Dollar General Full time

    Job SummaryAs a Store Manager at Dollar General, you will be responsible for the overall management of the store, including employee supervision, inventory management, and customer service. This is a leadership role that requires strong communication and problem-solving skills.Key ResponsibilitiesRecruit, train, and develop a team of sales associates to...


  • Groton, Connecticut, United States Henny Penny Full time

    Job DescriptionAt Henny Penny, we are seeking a highly skilled Store Operations Manager to join our team. As an Assistant Retail Manager, you will be responsible for leading the day-to-day operations of our store in the absence of the General Manager.The ideal candidate will have experience in managing and directing others, with a strong focus on customer...


  • Groton, Connecticut, United States TPG Hotels Resorts and Marinas Full time

    Job Summary:TPG Hotels, Resorts & Marina is seeking a highly motivated and customer-focused Marina Service Associate to join our team. As a Marina Service Associate, you will be the first point of contact for our guests and will be responsible for providing exceptional customer service, ensuring a positive experience for all visitors to our marina.Key...

  • Store Manager

    4 weeks ago


    Groton, Connecticut, United States Henny Penny Full time

    Job Title: General ManagerJob Summary:We are seeking a highly experienced and motivated General Manager to lead our Groton Store 36 team. The ideal candidate will have a proven track record in management and leadership in the retail/convenience field, with a strong focus on customer satisfaction and team development.Key Responsibilities:Lead and manage a...

  • Security Specialist

    4 weeks ago


    Groton, Connecticut, United States Naval Education and Training Command Full time

    Job SummaryAs a Security Specialist with the Naval Education and Training Command, you will play a critical role in ensuring the security and integrity of our operations. This position requires a highly skilled and experienced professional who can develop and implement effective security policies and procedures to protect our personnel, assets, and...


  • Groton, Connecticut, United States Henny Penny Full time

    Job DescriptionAt Henny Penny, we are seeking a highly skilled General Manager to lead our retail convenience store operations. As a key member of our team, you will be responsible for maximizing store profitability through effective team development, operational excellence, sales building, and financial performance management.Key Responsibilities:Ensure a...