Experience with using a Trial Master File, a plus. This is a hybrid position with 2 days in TRI ... Must have excellent time management skills, able to adhere to strict timelines and expectations.
Experience with using a Trial Master File, a plus. This is a hybrid position with 2 days in TRI ... Must have excellent time management skills, able to adhere to strict timelines and expectations.
Associate Director, Clinical Operations-TMF
Bethesda, MD · On-site
$130K - $155K/yr
Oversight of Clinical Operations Trial Master File (TMF) activities, including TMF project management, documentation, and review/ collection, with depth of knowledge of regulatory (FDA requirements ...
New
Associate Director, Clinical Operations-TMF
Bethesda, MD · On-site
$130K - $155K/yr
Oversight of Clinical Operations Trial Master File (TMF) activities, including TMF project management, documentation, and review/ collection, with depth of knowledge of regulatory (FDA requirements ...
New
Associate Director, Clinical Operations-TMF
Bethesda, MD · Hybrid
$36 - $49/hr
Oversight of Clinical Operations Trial Master File (TMF) activities, including TMF project management, documentation, and review/ collection, with depth of knowledge of regulatory (FDA requirements ...
New
Associate Director, Clinical Operations-TMF
Bethesda, MD · Hybrid
$36 - $49/hr
Oversight of Clinical Operations Trial Master File (TMF) activities, including TMF project management, documentation, and review/ collection, with depth of knowledge of regulatory (FDA requirements ...
New
In-House Clinical Research Associate
Bethesda, MD · On-site
$50 - $80/hr
... Manager, as required on clinical trial administrative duties. Duties may include but are not ... the Trial Master File (TMF) or another central documents file platform or system held by TRI or ...
In-House Clinical Research Associate
Bethesda, MD · On-site
$50 - $80/hr
... Manager, as required on clinical trial administrative duties. Duties may include but are not ... the Trial Master File (TMF) or another central documents file platform or system held by TRI or ...
... Manager, as required on clinical trial administrative duties. Duties may include but are not ... the Trial Master File (TMF) or another central documents file platform or system held by TRI or ...
... Manager, as required on clinical trial administrative duties. Duties may include but are not ... the Trial Master File (TMF) or another central documents file platform or system held by TRI or ...
Clinical Trial Manager - Full Service
Washington, DC · On-site
$120 - $170/hr
Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to ...
New
Clinical Trial Manager - Full Service
Washington, DC · On-site
$120 - $170/hr
Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to ...
New
Associate Director, Clinical Operations-TMF
Bethesda, MD · On-site
$130 - $155/hr
... Education Master's Degree Travel None Owns Trial Master File (TMF) strategy, quality ... Responsible forTMFproject management oversight within one or more complex drug development programs ...
New
Associate Director, Clinical Operations-TMF
Bethesda, MD · On-site
$130 - $155/hr
... Education Master's Degree Travel None Owns Trial Master File (TMF) strategy, quality ... Responsible forTMFproject management oversight within one or more complex drug development programs ...
New
MedTech Site Manager 1
Washington, DC · On-site
$74K - $124K/yr
Responsible for management of investigator site and Clinical Research Associate (CRA) activities ... Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist ...
MedTech Site Manager 1
Washington, DC · On-site
$74K - $124K/yr
Responsible for management of investigator site and Clinical Research Associate (CRA) activities ... Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist ...
MedTech Site Manager 1
Washington, DC · On-site
$74K - $124K/yr
Responsible for management of investigator site and Clinical Research Associate (CRA) activities ... Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist ...
MedTech Site Manager 1
Washington, DC · On-site
$74K - $124K/yr
Responsible for management of investigator site and Clinical Research Associate (CRA) activities ... Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist ...
The Senior Manager of Drug Safety and Medical Monitor will provide medical monitoring support to ... Trial Master File, shared drive, etc.) for all applicable clinical trials. * Conduct medical ...
The Senior Manager of Drug Safety and Medical Monitor will provide medical monitoring support to ... Trial Master File, shared drive, etc.) for all applicable clinical trials. * Conduct medical ...
Collaborate with Document Management team to archive DM-related documents in Trial Master File (TMF). * Write DM-related SOPs and/or Job aids and contribute to improving DM processes. Non-Essential ...
Collaborate with Document Management team to archive DM-related documents in Trial Master File (TMF). * Write DM-related SOPs and/or Job aids and contribute to improving DM processes. Non-Essential ...
Sr. In-House CRA
Rockville, MD · On-site +1
Under the high level supervision of the project site management staff oversight lead (i.e ... Performs upload of essential documents into the trial master file. * Independently communicates and ...
Sr. In-House CRA
Rockville, MD · On-site +1
Under the high level supervision of the project site management staff oversight lead (i.e ... Performs upload of essential documents into the trial master file. * Independently communicates and ...
Sr. In-House CRA
Rockville, MD · On-site
Under the high level supervision of the project site management staff oversight lead (i.e ... Performs upload of essential documents into the trial master file. * Independently communicates and ...
Sr. In-House CRA
Rockville, MD · On-site
Under the high level supervision of the project site management staff oversight lead (i.e ... Performs upload of essential documents into the trial master file. * Independently communicates and ...
Sr. In-House CRA
Rockville, MD · On-site
$85 - $120/hr
Under the high level supervision of the project site management staff oversight lead (i.e ... Performs upload of essential documents into the trial master file. * Independently communicates and ...
Sr. In-House CRA
Rockville, MD · On-site
$85 - $120/hr
Under the high level supervision of the project site management staff oversight lead (i.e ... Performs upload of essential documents into the trial master file. * Independently communicates and ...
Sr. In-House CRA
Rockville, MD · On-site
Under the high level supervision of the project site management staff oversight lead (i.e ... Performs upload of essential documents into the trial master file. * Independently communicates and ...
Sr. In-House CRA
Rockville, MD · On-site
Under the high level supervision of the project site management staff oversight lead (i.e ... Performs upload of essential documents into the trial master file. * Independently communicates and ...
Senior Clinical Research Associate / Clinical Research Associate II - Oncology - West Coast US - FSP
Washington, DC · On-site +1
... Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics * Identify and resolve ...
Senior Clinical Research Associate / Clinical Research Associate II - Oncology - West Coast US - FSP
Washington, DC · On-site +1
... Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics * Identify and resolve ...
Performance Tester
Bowie, MD · On-site
... Master File) BMF (Business Master File) CADE2 (Customer Account Data Engine 2) Testing Tools ... Manager, Team Concert, Doors Next Generation) · Microsoft (MS) Office Excel, MS Word, MS Project ...
Quick apply
Performance Tester
Bowie, MD · On-site
... Master File) BMF (Business Master File) CADE2 (Customer Account Data Engine 2) Testing Tools ... Manager, Team Concert, Doors Next Generation) · Microsoft (MS) Office Excel, MS Word, MS Project ...
IBM Mainframe Test Scheduler/Execution with IRS MBI and IRS Experience
Bowie, MD · On-site
$60K - $80K/yr
... File) BMF (Business Master File) CADE2 (Customer Account Data Engine 2) Preferred Skills ... Manager, Team Concert, Doors Next Generation) · Microsoft (MS) Office Excel, MS Word, MS Project ...
Quick apply
IBM Mainframe Test Scheduler/Execution with IRS MBI and IRS Experience
Bowie, MD · On-site
$60K - $80K/yr
... File) BMF (Business Master File) CADE2 (Customer Account Data Engine 2) Preferred Skills ... Manager, Team Concert, Doors Next Generation) · Microsoft (MS) Office Excel, MS Word, MS Project ...
Performance Tester
Bowie, MD · On-site
... Master File) BMF (Business Master File) CADE2 (Customer Account Data Engine 2) Testing Tools ... Manager, Team Concert, Doors Next Generation) · Microsoft (MS) Office Excel, MS Word, MS Project ...
Quick apply
Performance Tester
Bowie, MD · On-site
... Master File) BMF (Business Master File) CADE2 (Customer Account Data Engine 2) Testing Tools ... Manager, Team Concert, Doors Next Generation) · Microsoft (MS) Office Excel, MS Word, MS Project ...
IBM Mainframe Test Scheduler/Execution with IRS MBI and IRS Experience
Bowie, MD · On-site
$60K - $80K/yr
... File) BMF (Business Master File) CADE2 (Customer Account Data Engine 2) Preferred Skills ... Manager, Team Concert, Doors Next Generation) · Microsoft (MS) Office Excel, MS Word, MS Project ...
Quick apply
IBM Mainframe Test Scheduler/Execution with IRS MBI and IRS Experience
Bowie, MD · On-site
$60K - $80K/yr
... File) BMF (Business Master File) CADE2 (Customer Account Data Engine 2) Preferred Skills ... Manager, Team Concert, Doors Next Generation) · Microsoft (MS) Office Excel, MS Word, MS Project ...
Trial Master File Manager information
See Laurel, MD salary details
$44.1K - $50.4K
10% of jobs
$55.2K is the 25th percentile. Wages below this are outliers.
$50.4K - $56.6K
20% of jobs
$56.6K - $62.9K
9% of jobs
$62.9K - $69.2K
10% of jobs
The median wage is $70.1K / yr.
$69.2K - $75.4K
15% of jobs
$75.4K - $81.7K
6% of jobs
$86.6K is the 75th percentile. Wages above this are outliers.
$81.7K - $88K
7% of jobs
$88K - $94.2K
3% of jobs
$94.2K - $100.5K
14% of jobs
$100.5K - $106.8K
3% of jobs
$106.8K - $113K
3% of jobs
$44.1K
$74.9K
$113K
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Full-time
Re-posted 9 days ago
Job description
The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties. Duties may include but are not limited to: Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system held by TRI or Sponsor/Client. Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs.
Track essential regulatory documents in a centralized web-based system and/or other database. Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems. Coordinate or assist in distribution of trial-related materials to study sites.
May assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation. NOTE: Specialized experience in eTMF (e.g., Veeva Vault) processing and system administration skills-sets and/or additional responsibilities may be required for some staff. This job may serve as a transition or training role for the position of field CRA, as appropriate.Understanding of medical and clinical trials terminology
Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution. Able to work independently or with minimal supervision as well as within a team. Excellent attention to detail with organizational and prioritization skills for efficient productivity.
Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum). Excellent professional writing and verbal communication skills (position requires clear phone and email communication). Able to multi-task during the review/processing and preparation of essential regulatory documentation.
Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right. Must have excellent time management skills, able to adhere to strict timelines and expectations. Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus.
Experience with using a Trial Master File, a plus. This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.Understanding of medical and clinical trials terminology. Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution
Able to work independently or with minimal supervision as well as within a team. Excellent attention to detail with organizational and prioritization skills for efficient productivity. Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum).
Excellent professional writing and verbal communication skills (position requires clear phone and email communication). Able to multi-task during the review/processing and preparation of essential regulatory documentation. Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right.
Must have excellent time management skills, able to adhere to strict timelines and expectations. Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus. Experience with using a Trial Master File, a plus.
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.