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Clinical Trial Transparency Manager Jobs in Virginia

Clinical Trial Psych Rater

Fairfax, VA ยท Remote

$62K - $156K/yr

Clinical Trial Psych Rater - US Spanish Speaking Location: Remote/Virtual Hours: Estimated 10-16 ... Excellent organizational skills, attention to detail, time management, and problem-solving ability.

$68K - $93K/yr

Gathers and records all required study related to the Clinical Trial Management System (CTMS). Reports all Serious Adverse Events (SAE) to the Principle Investigator, monitor, sponsor, and IRB as ...

$68K - $93K/yr

Gathers and records all required study related to the Clinical Trial Management System (CTMS). Reports all Serious Adverse Events (SAE) to the Principle Investigator, monitor, sponsor, and IRB as ...

... Management (CRM) tool, to report/track progress and measure impact of that strategy. * Advanced level of competency connecting the study protocol, scientific principles and clinical trial ...

... Management (CRM) tool, to report/track progress and measure impact of that strategy. * Advanced level of competency connecting the study protocol, scientific principles and clinical trial ...

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Clinical Trial Transparency Manager information

What does a clinical trial transparency manager do?

A Clinical Trial Transparency Manager is responsible for ensuring that information about clinical trials is publicly available and compliant with global regulations. They oversee the registration of trials, disclosure of results, and publication of relevant data on public platforms like ClinicalTrials.gov and EudraCT. Their role also involves collaborating with cross-functional teams to maintain data accuracy and transparency, managing timelines for disclosure, and staying updated with changing regulatory requirements. Ultimately, they help promote trust and accountability in clinical research.

What skills and qualifications are needed to be a clinical trial transparency manager?

To thrive as a Clinical Trial Transparency Manager, you need expertise in clinical research regulations, data disclosure requirements, and a solid understanding of Good Clinical Practice (GCP), often backed by a relevant life sciences degree. Familiarity with clinical trial registries, submission portals, and systems like EudraCT, ClinicalTrials.gov, and data anonymization tools is crucial. Attention to detail, strong project management, and excellent communication skills help ensure compliance and effective collaboration with cross-functional teams. These competencies are vital to ensure regulatory compliance, protect patient privacy, and uphold the integrity and public trust in clinical research.

How does a clinical trial transparency manager collaborate with cross-functional teams to ensure compliance with disclosure requirements?

A Clinical Trial Transparency Manager works closely with regulatory affairs, data management, clinical operations, and legal teams to ensure all trial data and documentation meet global disclosure requirements. This collaboration often involves coordinating timelines, reviewing study results for public registries, and addressing queries from internal and external stakeholders. By facilitating clear communication across departments, the manager helps maintain data integrity and ensures that transparency standards are met efficiently. Regular meetings and shared project management tools are commonly used to streamline this cross-functional collaboration.

What is the difference between Clinical Trial Transparency Manager vs Clinical Data Coordinator?

AspectClinical Trial Transparency ManagerClinical Data Coordinator
CredentialsTypically requires a degree in life sciences, healthcare, or related field; certifications in clinical research or transparency are commonUsually holds a degree in health sciences, nursing, or related field; certifications in clinical data management may be preferred
Work EnvironmentWorks in regulatory, compliance, or clinical research departments, often within pharmaceutical or biotech companiesWorks in clinical trial data management, often within research organizations or clinical sites
Employer & IndustryPharmaceutical, biotech, or healthcare companies focusing on trial transparency and regulatory complianceResearch organizations, clinical trial sites, or CROs managing clinical data

The Clinical Trial Transparency Manager focuses on ensuring transparency and compliance of clinical trial data with regulatory standards, while the Clinical Data Coordinator manages the collection, validation, and organization of clinical trial data. Both roles require knowledge of clinical research processes but differ in their primary responsibilities and work settings.

What are the most commonly searched types of Clinical Trial Transparency jobs in Virginia?

The most popular types of Clinical Trial Transparency jobs in Virginia are:

What are popular job titles related to Clinical Trial Transparency Manager jobs in Virginia?

For Clinical Trial Transparency Manager jobs in Virginia, the most frequently searched job titles are:

What job categories do people searching Clinical Trial Transparency Manager jobs in Virginia look for?

The top searched job categories for Clinical Trial Transparency Manager jobs in Virginia are:

What cities in Virginia are hiring for Clinical Trial Transparency Manager jobs?

Cities in Virginia with the most Clinical Trial Transparency Manager job openings:

Clinical Trial & Pharmacovigilance Manager

VENESCO, LLC

Falls Church, VA โ€ข Hybrid

Full-time

Re-posted 23 days ago


Job description

Description

ย Clinical Trial & Pharmacovigilance Manager

Location: Hybrid
Job Type: Full-Time

Position Overview:
Venesco is seeking an experienced Clinical Trial & Pharmacovigilance Manager to oversee clinical trial operations and ensure robust safety surveillance practices.


Requirements

Key Responsibilities: ย  Manage clinical trial operations from startup through closeout ย  Oversee adverse event reporting and pharmacovigilance systems ย  Ensure compliance with ICH-GCP and regulatory requirements ย  Coordinate DSMB activities and safety reviews ย  Develop and maintain clinical study documentation ย  Collaborate with regulatory teams on submissions

Minimum Qualifications: ย  Advanced degree in clinical research, life sciences, or related healthcare field ย  8+ years of clinical operations and safety experience ย  Strong knowledge of ICH-GCP and FDA regulations

Preferred Qualifications: ย  Experience with Argus or ArisG safety databases ย  Clinical trial management certification MUST BE A US CITIZEN and US Board certified MD