TMF Implementation Specialist
King of Prussia, PA
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Hybrid
Brand: Joulé
Job ID: 351006
Date Posted: 05/19/2026
Shortcut: http://jobs.systemone.com/pdISuG
Job Title: TMF Implementation Specialist
Location: King of Prussia, PA
Type: Contract - 1 year
Contractor Work Model: Hybrid – onsite and remote
Joule is seeking an experienced TMF Implementation Specialist to lead the setup and management of a paper-based Trial Master File (TMF). This contract role will play a critical part in building a compliant TMF from the ground up, organizing and maintaining essential study documentation in accordance with ICH-GCP and regulatory standards. The ideal candidate will bring hands-on experience with paper TMF systems, strong organizational skills, and the ability to work onsite in King of Prussia to support document handling, filing, and audit readiness activities.
Responsibilities
- Lead the implementation and maintenance of a paper-based TMF system for clinical studies.
- Develop and standardize TMF filing structures, indexing conventions, and document control procedures.
- Ensure TMF completeness, accuracy, quality, and inspection readiness throughout the lifecycle of clinical trials.
- File, organize, track, archive, and retrieve essential clinical documents in accordance with company SOPs and regulatory guidelines.
- Perform routine TMF quality reviews, reconciliation activities, and gap analyses to identify missing or incomplete documents.
- Create and maintain TMF-related plans, indexes, SOPs, work instructions, logs, and tracking tools
- Bachelor’s degree or equivalent combination of education and experience
- TMF management or clinical document management experience within the pharmaceutical, biotechnology, or CRO industry
- Hands-on experience implementing or managing paper TMF systems
- Familiarity with TMF Reference Model and inspection readiness standards
- Proficiency with Microsoft Office applications and TMF tracking tools
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
#LI- LI-EL1
-
Temporary Senior Manager Compliance
Alameda, CA
Job Title: Senior Manager, RA Quality, Standards & Training Location: Alameda, CA Type: 6-month contract (renewable) Compensation: $80-100/hour (dependent on experience) Contractor Work Model: Remote or Hybrid for local candidates Hours: 40.0 Responsib...
Date Posted: 05/12/2026 Recommended
-
Compliance Specialist III
Sunnyvale, California
Job Title: Compliance Specialist III Location: Sunnyvale, California Type: 6 month contract Compensation: $25/HOUR Contractor Work Model: Onsite Hours: 40.0 Overview This role supports quality and regulatory compliance activities within a medical devic...
Date Posted: 04/27/2026 Recommended
-
Senior Computer System Validation Consultant
San Diego, CA
Job Title: Senior Computer System Validation Consultant Location: San Diego, CA Type: 6 month contract Compensation: $78-84.50/hour, depending on qualifications Contractor Work Model: Onsite – onsite Hours: 40.0 Overview We are seeking an experienced S...
Date Posted: 05/18/2026 Recommended
-
Senior Clinical Research Associate
Calgary, Alberta
Job Title: Senior Clinical Research Associate Location: Calgary, Alberta or Edmonton, Alberta Type: SALARIED Compensation: $130,000.00 - $150,000.00 CAD based years of experience and education Hours: 40.0 Responsibilities Provide site management and su...
Date Posted: 05/06/2026 Recommended
-
Director, Project QA Compliance (PERM)
Lake Forest, Illinois
Job Title: Director, Project QA Compliance (PERM) Location: Lake Forest, Illinois Type: Direct Hire Full Time permanent direct with client Compensation: $150,000 - $190,000 Work Model: Hybrid – onsite Tues and Thursday Hours: 40.0 This is an opportunit...
Date Posted: 05/18/2026 Recommended
-
Document Controller
Indianapolis, IN
Job Title: Document Controller Location: Indianapolis, IN Hours: Mon - Fri 8am - 5pm, onsite Compensation: $34.94 - $41.11/hr Type: Contract, Potential for extension or conversion to permanent Responsibilities Owns and manages the end-to-end document c...
Date Posted: 03/25/2026 Recommended
-
Manufacturing Technician I
Fremont, CA
Job Title: Manufacturing Technician I Location: Fremont, CA Type: Contract Compensation: $20.66 Contractor Work Model: Onsite Hours: Sun-Wed Days - 38 Hours/week Sun-Tues 3PM-1:30AM Wed 3PM-11:30PM Overview Leading pharmaceutical company looking for an...
Date Posted: 04/28/2026 Recommended
-
Technical Documentation Specialist
Branchburg, NJ
Job Title: Technical Documentation Specialist Location: Branchburg NJ Type: Contract Compensation: $25-$28.17/hr Work Model: Hybrid – onsite and remote Responsibilities Lead the end-to-end development, writing, and rigorous editing of Instructions for ...
Date Posted: 05/12/2026 Recommended
-
Infrastructure & Clean Utilities Maintenance Technician III
Athens, GA
Job Title: Infrastructure & Clean Utilities Maintenance Technician III Location: Athens, GA Type: Contract Compensation: $30.67 Contractor Work Model: onsite Hours: Tuesday–Saturday, 4:00 PM–12:30 AM Overview Leading pharmaceutical company looking for ...
Date Posted: 05/19/2026 Recommended
-
Senior Quality Control Specialist
Gainesville, GA
Job Title: Senior Quality Control Specialist Location: Gainesville, GA Type: Contract Compensation: $30-$36.66 Contractor Work Model: Onsite – onsite Hours: 8AM-4:30PM, 40 hours/week Overview Leading pharmaceutical manufacturing and animal health compa...
Date Posted: 05/14/2026 Recommended
-
Manufacturing Associate
Rockville, MD
Job Title: Manufacturing Associate Location: Rockville, MD Type: Contract Compensation: $18 - $25/hour Overview Biopharmaceutical Company is seeking a Manufacturing Associate to join their team in support of the development and production of therapies ...
Date Posted: 05/15/2026 Recommended
-
Procurement Specialist
Alameda, CA
Job Title: Procurement Specialist Location: Alameda, CA Type: Contract Compensation: $40.00 per hour Contractor Work Model: Onsite Hours: 40.0 hours per week Overview Temporary Procurement Specialist to support the Strategic Sourcing & Procurement team...
Date Posted: 04/06/2026 Recommended
-
Central Weight Lab Tech - 2nd Shift
Branchburg, NJ
Job Title: Central Weight Lab Tech - 2nd Shift Location: Branchburg, NJ Type: Contract Compensation: $24.00/hr Contractor Work Model: Onsite Responsibilities Perform weighing and dispensing of raw materials for process orders, inventory management, and...
Date Posted: 05/19/2026 Recommended
-
Food Safety & QA Specialist
Monroe, NJ
Job Title: Food Safety & QA Specialist Location: Monroe, NJ Type: Direct Hire Compensation: $50000 - $60000 annually Contractor Work Model: Onsite Hours: 8 AM- 5 Pm M-F Responsibilities: Primarily focus on the implementation and maintenance of food saf...
Date Posted: 05/06/2026 Recommended
-
Environmental, Health and Safety Specialist
Mahwah, NJ
Job Title: Environmental, Health and Safety Specialist Location: Mahwah, NJ Type: Contract Compensation: $60.00 - $75.00 per hour Hours: 40 hours per week Responsibilities Provide technical support and EHS leadership to the Mahwah site, acting as a sub...
Date Posted: 04/02/2026 Recommended
-
Electro-Mechanical Assembler
Perkasie, PA
Job Title: Electro-Mechanical Assembler Location: Perkasie, PA (Onsite) Type: Contract Compensation: $18-$23/hour (depending on experience) Hours: Monday-Friday, 7:00am-3:30pm Overview A growing manufacturing team is hiring Electro-Mechanical Assembler...
Date Posted: 05/04/2026 Recommended
-
Customer Service Representative
Lenexa, Kansas
Job Title: Customer Service Representative Location: Lenexa, KS Type: Contract Contractor Work Model: Onsite – onsite Hours: M-F 8:30 am - 5:00 pm CT Responsibilities Handle day-to-day interactions between the company and customers to ensure a consiste...
Date Posted: 05/20/2026 Recommended
-
Project Engineer III
Fremont, CA
Job Title: Project Engineer III Location: Fremont, CA Type: Contract Compensation: $90-100/hr Contractor Work Model: Onsite Hours: 40.0 Overview A leading pharmaceutical company is seeking an experienced Project Engineer III to support engineering init...
Date Posted: 05/14/2026 Recommended
-
Sr Research Associate II
Novato, CA
Job Title: Sr Research Associate II Location: Novato, CA Type: Contract Compensation: $40-$47.10/hr Contractor Work Model: Onsite with occasional evening or weekend hours expected Hours: Monday-Friday 8am to 5pm Overview Leading pharmaceutical company ...
Date Posted: 05/14/2026 Recommended
-
Manufacturing Associate
Novato, CA
Job Title: Manufacturing Associate Location: Novato, CA Type: Contract Compensation: $28.00 Contractor Work Model: Onsite – onsite Hours: Thursday - Saturday with Alternating Wednesdays (6am to 7pm) / Rotating 12hour shift Overview Leading biotechnolog...
Date Posted: 05/13/2026 Recommended
-
Metrology/Incoming Inspection Supervisor
Orangeburg, NY
Job Title: Metrology / Incoming Inspection Supervisor Location: Blauvelt, NY Employment Type: Contract, 6 months+ Opportunity to convert to direct hire Work Model: Onsite Hours: 7:30 am-4 pm Monday-Friday Compensation: $50.00 – $55.00 per hour Overview...
Date Posted: 05/19/2026 Recommended
-
Sr Manager Standards & Systems
Plainsboro, NJ
Job Title: Sr Manager Standards & Systems Location: REMOTE Hours: 40.0 Overview Responsibilities Serve as the primary point of contact for activities related to “Rave Safety Gateway” implementation, developing, testing, and implementing complex edit ch...
Date Posted: 04/28/2026 Recommended
-
Manufacturing Associate
Novato, CA
Job Title: Manufacturing Associate Location: Novato, CA Type: Contract Compensation: $28.00 + shift differential Contractor Work Model: Onsite – onsite Hours: Sunday- Tuesday, alternating Wednesdays from 6am-7pm Overview Leading biotechnology company l...
Date Posted: 05/14/2026 Recommended
-
Facility Maintenance Mechanic
Cranbury, NJ
Job Title: Facility Maintenance Mechanic Location: Cranbury, NJ Hours / Schedule: Monday–Friday (8:00 AM – 5:00 PM), some flexibility for early / late shifts and occasional weekends as needed Type: Contract To Hire Compensation: $34.50 per hour pending...
Date Posted: 05/12/2026 Recommended
-
Manufacturing Associate
Novato, CA
Job Title: Manufacturing Associate Location: Novato, CA Type: Contract Compensation: $28.00/hr + shift differential Contractor Work Model: Onsite – onsite Hours: Alternating Saturdays /Sundays to Tuesdays from 6pm to 7 am Overview Leading biotechnology...
Date Posted: 05/13/2026 Recommended
-
Warehouse Associate
Savannah, GA
Job Title: Warehouse Associate Location: Garden City, GA 31408 Type: Contract Compensation: $21.00 Contractor Work Model: Onsite – onsite Overview We are seeking a reliable and safety-focused Warehouse Associate to join our team in Garden City, GA. Thi...
Date Posted: 05/14/2026 Recommended
-
Manufacturing Associate (Downstream)
Pennington, New Jersey
Job Title: Manufacturing Associate (Upstream & Downstream) Location: Pennington, New Jersey Type: Contract Compensation: $25.00–$32.00 per hour Contractor Work Model: Onsite Hours: 40.0 hours per week 8a-5p Responsibilities Support both Upstream and Do...
Date Posted: 05/13/2026 Recommended
-
Product Data & Documentation Associate
Princeton, New Jersey
Job Title: Product Data & Documentation Associate Location: Princeton, New Jersey (Hybrid) Type: Contract Compensation: $24.00 per hour Responsibilities Assist with the generation and compilation of technical documentation for product information files...
Date Posted: 05/07/2026 Recommended
-
Regulatory Affairs Specialist
Madison Heights, Michigan
Job Title: Regulatory Affairs Specialist Location: Madison Heights, MI Contractor Work Model: Onsite Hours: M – F 8am – 5pm Compensation: $26.00/hr Type: Contract, Potential for extension or conversion to permanent Responsibilities Ensure that our cust...
Date Posted: 05/15/2026 Recommended
-
DIRECTOR OF ACUTE CARE SERVICES
Wellsville, NY
Job Title: DIRECTOR OF ACUTE CARE SERVICES Location: Wellsville, NY Type: Direct Hire Contractor Work Model: Onsite Salary: $100-120K DIRECTOR OF ACUTE CARE SERVICES Statement of Purpose: The Director of Acute Care Services manages and coordinates the ...
Date Posted: 04/22/2026 Recommended