Essential Functions Coordinate and oversee TMY study closure and archival actives Coordinate and support the TMF compliance team with TMF transfers and migrations. Develop integrated study management ...
Essential Functions Coordinate and oversee TMY study closure and archival actives Coordinate and support the TMF compliance team with TMF transfers and migrations. Develop integrated study management ...
Coordinate and support the TMF compliance team with TMF transfers and migrations. * Develop integrated study management plans with the core project team. * Support study teams with Investigator Site ...
New
Coordinate and support the TMF compliance team with TMF transfers and migrations. * Develop integrated study management plans with the core project team. * Support study teams with Investigator Site ...
New
... TMF transfers and migrations. • Develop integrated study management plans with the core project team. • Support study teams with Investigator Site File questions • Set objectives of the core ...
... TMF transfers and migrations. • Develop integrated study management plans with the core project team. • Support study teams with Investigator Site File questions • Set objectives of the core ...
Coordinate and support the TMF compliance team with TMF transfers and migrations. * Develop integrated study management plans with the core project team. * Support study teams with Investigator Site ...
Coordinate and support the TMF compliance team with TMF transfers and migrations. * Develop integrated study management plans with the core project team. * Support study teams with Investigator Site ...
Essential Functions Coordinate and oversee TMY study closure and archival actives Coordinate and support the TMF compliance team with TMF transfers and migrations. Develop integrated study management ...
Essential Functions Coordinate and oversee TMY study closure and archival actives Coordinate and support the TMF compliance team with TMF transfers and migrations. Develop integrated study management ...
Trial Master File (TMF) Management * Risk Management * Budget Tracking and Reconciliation * Cross-Functional Collaboration * Project Management * Stakeholder Management Why AstraZeneca: Here, your ...
New
Trial Master File (TMF) Management * Risk Management * Budget Tracking and Reconciliation * Cross-Functional Collaboration * Project Management * Stakeholder Management Why AstraZeneca: Here, your ...
New
Global Study Manager
Durham, NC · On-site
Trial Master File (TMF) Management * Risk Management * Budget Tracking and Reconciliation * Cross-Functional Collaboration * Project Management * Stakeholder Management Why AstraZeneca: Here, your ...
Global Study Manager
Durham, NC · On-site
Trial Master File (TMF) Management * Risk Management * Budget Tracking and Reconciliation * Cross-Functional Collaboration * Project Management * Stakeholder Management Why AstraZeneca: Here, your ...
Global Study Manager
Durham, NC · On-site
Trial Master File (TMF) Management * Risk Management * Budget Tracking and Reconciliation * Cross-Functional Collaboration * Project Management * Stakeholder Management Why AstraZeneca: Here, your ...
Global Study Manager
Durham, NC · On-site
Trial Master File (TMF) Management * Risk Management * Budget Tracking and Reconciliation * Cross-Functional Collaboration * Project Management * Stakeholder Management Why AstraZeneca: Here, your ...
Ensure study-related documentation within assigned scope is complete, accurate, and maintained in the Trial Master File (TMF). Support budget management activities, including invoice reconciliation ...
New
Ensure study-related documentation within assigned scope is complete, accurate, and maintained in the Trial Master File (TMF). Support budget management activities, including invoice reconciliation ...
New
Site Management Associate II
Durham, NC · On-site
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Site Management Associate II
Durham, NC · On-site
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Site Management Associate II
Durham, NC · On-site
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Site Management Associate II
Durham, NC · On-site
Manages records flow with sites and off-site facilities * Prepares regulatory and ethics committee ... Files trial records in the TMF and performs regular TMF checks on a site and country level
Senior Clinical Line Manager
Raleigh, NC · On-site
... TMF management. * Manages site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites. * May conduct ...
Senior Clinical Line Manager
Raleigh, NC · On-site
... TMF management. * Manages site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites. * May conduct ...
Study Activation Manager
Raleigh, NC · On-site
Promote Trial Master File (TMF) completeness, accuracy, and inspection readiness for study start-up ... Ability to manage multiple trials, priorities, and sponsor deliverables accurately and efficiently.
Study Activation Manager
Raleigh, NC · On-site
Promote Trial Master File (TMF) completeness, accuracy, and inspection readiness for study start-up ... Ability to manage multiple trials, priorities, and sponsor deliverables accurately and efficiently.
Promote Trial Master File (TMF) completeness, accuracy, and inspection readiness for study start-up ... Ability to manage multiple trials, priorities, and sponsor deliverables accurately and efficiently.
Promote Trial Master File (TMF) completeness, accuracy, and inspection readiness for study start-up ... Ability to manage multiple trials, priorities, and sponsor deliverables accurately and efficiently.
Project Manager I, RWE
Morrisville, NC · On-site
Routinely reviews the TMF to ensure quality, completeness and inspection readiness. * Coordinates ... Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep ...
Project Manager I, RWE
Morrisville, NC · On-site
Routinely reviews the TMF to ensure quality, completeness and inspection readiness. * Coordinates ... Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep ...
Project Manager - Future roles (US) Syneos Health is a leading fully integrated biopharmaceutical ... Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ...
Project Manager - Future roles (US) Syneos Health is a leading fully integrated biopharmaceutical ... Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ...
Clinical Project Manager (Early Phase)
Morrisville, NC · On-site
$80K - $210K/yr
Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ... Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep ...
Clinical Project Manager (Early Phase)
Morrisville, NC · On-site
$80K - $210K/yr
Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ... Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep ...
Project Manager - Future roles (US) Syneos Health ® is a leading fully integrated ... Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ...
Project Manager - Future roles (US) Syneos Health ® is a leading fully integrated ... Routinely reviews the TMF to ensure quality, completeness and inspection readiness * Coordinates ...
Data Management, TMF Operations, etc.) * Oversee regional startup and feasibility activities. * Assist in vendor management activities as required per project. * Perform review of visit reports for ...
Data Management, TMF Operations, etc.) * Oversee regional startup and feasibility activities. * Assist in vendor management activities as required per project. * Perform review of visit reports for ...
Sr. Clinical Operations Lead (Clinical Trial Manager)
Raleigh, NC · Remote
$86K - $143K/yr
Data Management, TMF Operations, etc.) * Oversee regional startup and feasibility activities. * Assist in vendor management activities as required per project. * Perform review of visit reports for ...
Quick apply
Sr. Clinical Operations Lead (Clinical Trial Manager)
Raleigh, NC · Remote
$86K - $143K/yr
Data Management, TMF Operations, etc.) * Oversee regional startup and feasibility activities. * Assist in vendor management activities as required per project. * Perform review of visit reports for ...
Tmf Manager information
See Raleigh, NC salary details
$28.04 - $33.99
4% of jobs
$33.99 - $39.93
6% of jobs
$39.93 - $45.88
7% of jobs
$50.34 is the 25th percentile. Wages below this are outliers.
$45.88 - $51.83
9% of jobs
$51.83 - $57.78
15% of jobs
The median wage is $60.40 / hr.
$57.78 - $63.73
18% of jobs
$67.96 is the 75th percentile. Wages above this are outliers.
$63.73 - $69.67
21% of jobs
$69.67 - $75.62
7% of jobs
$75.62 - $81.57
6% of jobs
$81.57 - $87.52
3% of jobs
$87.52 - $93.46
2% of jobs
$28
$60
$93
How much do tmf manager jobs pay per hour?
What is a TMF Manager?
A TMF (Trial Master File) Manager is responsible for overseeing the management, maintenance, and compliance of clinical trial documentation. They ensure that the TMF is accurate, complete, and inspection-ready in accordance with regulatory requirements, such as ICH-GCP and FDA guidelines. TMF Managers collaborate with clinical teams, quality assurance, and regulatory authorities to support audit and inspection activities. Their role is critical in ensuring data integrity and regulatory compliance throughout the clinical trial lifecycle.
What are the key skills and qualifications needed to thrive as a TMF Manager?
To excel as a TMF Manager (Trial Master File Manager), you need a solid understanding of clinical trial documentation, GCP (Good Clinical Practice) guidelines, and regulatory requirements—typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management software, and relevant industry certifications such as RAC or DIA TMF certificates is important. Exceptional attention to detail, organizational skills, and the ability to communicate effectively across cross-functional teams distinguish top TMF Managers. These competencies are essential for ensuring the integrity, completeness, and audit-readiness of clinical trial documentation throughout the study lifecycle.
What are some typical challenges a TMF Manager might face in their role?
TMF Managers often encounter challenges such as ensuring consistent TMF document quality across multiple studies, meeting tight regulatory submission deadlines, and facilitating communication among global project teams. Keeping the TMF up to date and audit-ready requires strong organizational skills and proactive problem-solving, as studies can involve large volumes of documentation and frequent protocol amendments. Effective TMF Managers routinely collaborate with clinical, regulatory, and quality assurance teams to ensure document accuracy and regulatory compliance. Overcoming these challenges is key to maintaining smooth clinical trial operations and supporting successful regulatory inspections.
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Clinical Project Manager- TMF Archivist
Durham, NC
Full-time
Posted 4 days ago
IQVIA rating
8.1
Based on 53 frontline employees who took The Breakroom Quiz
Job description
Job Overview
Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.
Essential Functions
Coordinate and oversee TMY study closure and archival actives
Coordinate and support the TMF compliance team with TMF transfers and migrations.
Develop integrated study management plans with the core project team.
Support study teams with Investigator Site File questions
Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
May serve as primary or backup project contact with customer and would then own the relationship with the project's key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
Ensure the financial success of the project.
Forecast and identify opportunities to accelerate activities to bring revenue forward.
Identify changes in scope and manage change control process as necessary.
Identify lessons learned and implement best practices.
May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
Adopt corporate initiatives and changes and serve as a change advocate when necessary.
Provide input to line managers of their project team members' performance relative to project tasks.
Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;
Qualifications
Bachelor's Degree Life sciences or related field Req
5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience. Req
Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience. Req
Experience working within the Veeva Vault TMF
Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
Problem solving - Strong problem solving skills.
Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
Organization - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
Prioritization - Ability to handle conflicting priorities.
Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
Quality - Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.About IQVIA
Sourced by ZipRecruiter
At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.
Industry
Health care and social assistance
Company size
10,000+ Employees
Headquarters location
Durham, NC, US