Document Management Specialist

1 month ago


Cambridge, Cambridgeshire, United Kingdom Alimentiv Full time
Job Title: TMF Operations Manager

Alimentiv is seeking a highly skilled TMF Operations Manager to join our team. As a key member of our operations team, you will be responsible for ensuring the smooth delivery of TMF services, collaborating with internal and external customers, and driving staff performance and development.

Key Responsibilities:
  • Ensure TMF deliverables meet/exceed project/study team expectations regarding quality, timeliness, and completeness.
  • Provide input and guidance on escalated TMF issues, considering the applicable level of risk.
  • Collaborate with other clinical teams and functional leadership to manage project-related challenges and achieve exemplary customer service.
  • Partner with internal and external stakeholders to address procedural gaps and optimize TMF Management technology, processes, and standards.
  • Serve as a subject matter expert on TMF Management Best Practices to ensure management of TMFs in a consistent and standardized manner.
  • Provide education, feedback, and support to study teams to build knowledge and awareness of good document management practices and apply lessons learned across studies.
  • Support Revenue Management during change orders that require adjustments to TMF hours due to a change in study scope/services.
Staff Management & Engagement:
  • Monitor and review performance management of direct reports, conducting regular one-to-one meetings to discuss performance, employing coaching and mentoring skills, constructive criticism, and help with goal setting and management through empowerment and motivation techniques.
  • Hiring and oversight of staff onboarding plan.
  • Study resource allocation (primarily within product line) in accordance with study scope and milestones.
  • Evaluate training needs for assigned staff.
  • Establish and track performance metrics by role.
  • Assist staff with establishing priorities and timelines across multiple projects.
Corporate Operational Management:
  • Create a positive working environment oriented to trust, open communication, and creative thinking.
  • Propose and collaborate on department goals, initiatives, and strategies.
  • Facilitate TMF oversight discussions to create solutions to address business and operational challenges.
  • Ensure operational efficiency and excellence by facilitating review cycles on current processes for continuous improvement.
  • Support with project costing and management of expected versus actual budgets.
  • Consult on the department budget and determine staff needs for training and travel.
Qualifications:
  • A minimum of a college diploma/degree and 7-9 years of relevant experience.
  • Familiarity with the Trial Master File Reference Model, comprehensive understanding of management of TMF content within an electronic platform, good document practices, and knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
  • Previous coaching/mentorship and supervisory/line management experience is preferred.
Working Conditions:
  • Home-based.

Salary: £49,000 - £82,000 a year + bonus



  • Cambridge, Cambridgeshire, United Kingdom ELITS Full time

    ELITS Canada Inc is a subsidiary of Accelerate at Iver, a leading technology company with a strong focus on digitization and transformation projects. As a SharePoint Document Management Specialist, you will play a key role in enhancing our organization's management system structure and document control processes.Key Responsibilities:Management System...


  • Cambridge, Cambridgeshire, United Kingdom ELITS Full time

    ELITS Canada Inc is a subsidiary of Accelerate at Iver, a leading technology company with a strong focus on digitization and transformation projects. As a SharePoint Document Management Specialist, you will play a key role in enhancing our organization's management system structure and document control processes.Key Responsibilities:Management System...


  • Cambridge, Cambridgeshire, United Kingdom ARM Full time

    Join Arm's Team of Technical WritersWe are seeking a highly motivated and detail-oriented undergraduate to join our team of Technical Writers at Arm's Cambridge offices. As a Technical Writer, you will play a crucial role in documenting the next-generation technology and working alongside some of the world's best engineers.Key Responsibilities:Craft and...


  • Cambridge, Cambridgeshire, United Kingdom ARM Full time

    Join Arm's Team of Technical WritersWe are seeking a highly motivated and detail-oriented undergraduate to join our team of Technical Writers at Arm's Cambridge offices. As a Technical Writer, you will play a crucial role in documenting the next-generation technology and working alongside some of the world's best engineers.Key Responsibilities:Craft and...


  • Cambridge, Cambridgeshire, United Kingdom AVEVA Full time

    A global leader in industrial software, AVEVA is shaping the future of innovation.As a key member of our global technical writing team, you will collaborate with skilled software engineers to write and publish high-quality technical documentation for our products and solutions.Your primary responsibilities will include:Transforming complex technical concepts...


  • Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full time

    About the RoleHays Specialist Recruitment Limited is seeking a skilled Quantity Surveyor to join their commercial team in East Anglia. As a key member of the team, you will be responsible for managing multiple projects, ranging from £1m to £5m, and collaborating with clients to deliver successful outcomes.Key ResponsibilitiesProcurement of suppliers and...


  • Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full time

    About the RoleHays Specialist Recruitment Limited is seeking a skilled Quantity Surveyor to join their commercial team in East Anglia. As a key member of the team, you will be responsible for managing multiple projects, ranging from £1m to £5m, and collaborating with clients to deliver successful outcomes.Key ResponsibilitiesProcurement of suppliers and...


  • Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full time

    About the RoleHays Specialist Recruitment Limited is seeking a skilled Quantity Surveyor to join their commercial team in East Anglia. As a key member of the team, you will be responsible for managing multiple projects, ranging from £1m to £5m, and collaborating with clients to deliver successful outcomes.Key ResponsibilitiesProcure and manage suppliers...


  • Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full time

    About the RoleHays Specialist Recruitment Limited is seeking a skilled Quantity Surveyor to join their commercial team in East Anglia. As a key member of the team, you will be responsible for managing multiple projects, ranging from £1m to £5m, and collaborating with clients to deliver successful outcomes.Key ResponsibilitiesProcure and manage suppliers...


  • Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    About the RoleThe University of Cambridge is seeking a highly skilled Collections Documentation and Access Assistant to join its esteemed Collections team. This exciting opportunity will enable the successful candidate to work closely with a small team dedicated to supporting world-class teaching and research by caring for and providing access to the...


  • Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    About the RoleThe University of Cambridge is seeking a highly skilled Collections Documentation and Access Assistant to join its esteemed Collections team. This exciting opportunity will enable the successful candidate to work closely with a small team dedicated to supporting world-class teaching and research by caring for and providing access to the...


  • Cambridge, Cambridgeshire, United Kingdom Encore Estate Management Full time

    Estate Management Resourcing SpecialistWe are seeking a highly organized and proactive Estate Management Resourcing Specialist to join our team at Encore Estate Management. In this role, you will be responsible for assisting in the recruitment of employees across the Group, including attracting talent through advertising, social media, referrals, and other...


  • Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    About the RoleThe University of Cambridge is seeking a highly skilled Collections Documentation and Access Assistant to join its esteemed Collections team. This exciting opportunity will enable the successful candidate to work closely with a small team dedicated to supporting world-class teaching and research by caring for and providing access to the...


  • Cambridge, Cambridgeshire, United Kingdom University of Cambridge Full time

    About the RoleThe University of Cambridge is seeking a highly skilled Collections Documentation and Access Assistant to join its esteemed Collections team. This exciting opportunity will enable the successful candidate to work closely with a small team dedicated to supporting world-class teaching and research by caring for and providing access to the...


  • Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full time

    About the RoleWe are seeking a highly skilled Transformational Change Project Manager to join our team at Hays Specialist Recruitment Limited. As a key member of our Value Delivery Office, you will play a critical role in driving organizational agility and facilitating business growth.Key ResponsibilitiesDevelop and implement change management strategies to...


  • Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full time

    About the RoleWe are seeking a highly skilled Transformational Change Project Manager to join our team at Hays Specialist Recruitment Limited. As a key member of our Value Delivery Office, you will play a critical role in driving organizational agility and facilitating business growth.Key ResponsibilitiesDevelop and implement change management strategies to...


  • Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full time

    **Job Summary**Hays Specialist Recruitment Limited is seeking a highly skilled Senior Project Manager to lead a commercial project in Cambridge. As a Senior Project Manager, you will be responsible for the following:Understanding of the contract requirements as contained within the tender documentation and an understanding of the key aspects of the project...


  • Cambridge, Cambridgeshire, United Kingdom Streamline Services Consultancy Limited Full time

    Document Controller Opportunity in CambridgeWe are seeking a skilled Document Controller to join our team at Streamline Services Consultancy Limited in Cambridge. As a Document Controller, you will play a crucial role in ensuring the smooth operation of our M&E projects.Key Responsibilities:Manage and maintain accurate and up-to-date documentation for M&E...


  • Cambridge, Cambridgeshire, United Kingdom Hays Specialist Recruitment Limited Full time

    About the Role:We are seeking a skilled Project Manager to lead our transformational change initiatives. The successful candidate will have a proven track record of delivering complex projects and will be responsible for developing and implementing change management strategies to support our transformation program.Key Responsibilities:Develop and implement...


  • Cambridge, Cambridgeshire, United Kingdom Streamline Services Consultancy Limited Full time

    Document Controller Opportunity in M&E SectorWe are seeking a skilled Document Controller to join our team at Streamline Services Consultancy Limited in Cambridge. As a Document Controller, you will play a crucial role in managing documents for our M&E projects.Key Responsibilities:Manage and maintain accurate and up-to-date documentation for M&E...