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Clinical Trial Transparency Manager Jobs in Michigan

DM Clinical

Study Manager I (4187)

Bay City, MI · On-site

A Study Manager I is responsible to ensure that quality research is conducted at assigned ... Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator ...

Georgetown University

Clinical Research Nurse

Detroit, MI · On-site

$54.62 - $100.49/hr

The clinical trial nurse also acts as study coordinator for research studies. Additional duties ... The Research Nurse is responsible for managing at least 15 trials out of the overall portfolio of ...

Stryker

Staff Biostatistician (Remote)

Portage, MI · On-site +1

$124K - $207K/yr

... clinical trial execution and data evaluation. * Collaborate with clinical, data management ... S. work location and transparency guide to find the pay range for your location. Travel Percentage ...

Georgetown University

Data Analyst

Detroit, MI · On-site

$75.25/hr

Work Interactions The Data Analyst will work with and assist the Clinical Research Coordinator, Regulatory Specialist, and Clinical Trial Manager by interacting with the clinical trial sponsor and ...

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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 Michigan?

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

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

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

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

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

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

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

Clinical Trial Transparency Manager jobs near you

Study Manager I (4187)

DM Clinical

Bay City, MI • On-site

Other

Posted 9 days ago

Job description

A Study Manager I is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis.
DUTIES & RESPONSIBILITIES
  • Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis.
  • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
  • Adherence and compliance to the assigned protocols at their respective site(s).
  • Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to
  • Sponsor-provided and IRB-approved Protocol Training
  • All relevant Protocol Amendments Training
  • Any study-specific Manuals Training as applicable
  • Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
  • Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s).
  • Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s).
  • Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
  • Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner.
  • Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner.
  • Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation.
  • Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines.
  • Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
  • Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial.
  • Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents.
  • Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site.
  • Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned.
  • Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
  • Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s).
  • Being prepared for and available at all required company meetings.
  • Submitting required administrative paperwork per company timelines.
  • Occasionally attending out-of-town Investigator Meetings.
  • Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
  • Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
  • Facilitate effective communication between patients, healthcare providers, and research staff
  • Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
  • Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
  • Facilitate effective communication between patients, healthcare providers, and research staff
  • Any other matters as assigned by management.

KNOWLEDGE & EXPERIENCE
Education:
  • High School Diploma or equivalent required
  • Bachelor's degree preferred
  • Foreign Medical Graduates preferred

Experience:
  • Minimum of 5 years experience in Clinical Research
  • Supervisory experience preferred
  • Wide therapeutic range of clinical trials experience preferred
  • Regulatory research experience is a plus

Credentials:
  • ACRP or equivalent certification is preferred

Knowledge and Skills:
  • Goals-driven while continuously maintaining quality.
  • Must be detailed-oriented, proactive, and able to take initiative.
  • Must have strong written and communication skills.
  • Must have excellent customer service skills.
  • Proficient communication and comprehension skills both verbal and written in the English language are required.
  • Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred

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