Clinical Trials Disclosure Specialist

4 weeks ago


Madison, New Jersey, United States Omni Inclusive Full time
Job Summary:

The Clinical Trial Disclosure Senior Specialist will provide operational support for the redaction of clinical trial documents in accordance with evolving global regulations. This role will collaborate with various stakeholders to operationalize redaction requirements and provide vendor oversight to support document redactions.

Key Responsibilities:

  • Manage and coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
  • Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements.
  • Provide vendor oversight to support document redactions.
  • Work with IT, as needed, to implement technology solutions related to clinical trial disclosure.
  • Manage and track redaction book-of-work; compile and report on volume and performance metrics.
  • Provide operational support to CT Results Specialists, as required.
  • Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements.
  • Communicate with internal and external stakeholders to improve on processes and manage unmet need.
  • Train new staff and develops job aids, work instructions, and user guides, as needed.

Candidate Requirements:

  • BA/BS or MA/MS in scientific or medical field.
  • 2-3 years of document redaction and 5 years relevant work experience in a scientific or medical field with BA/BS.
  • US military experience will be considered towards industry experience requirements.
  • Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.).
  • Familiarity and comfortability working with and discussing scientific data.
  • Project and stakeholder management experience.
  • Demonstrated ability to work independently and seek out support when needed.
  • Exceptional written and oral communication skills.
  • Strong organizational skills with the ability to multitask and prioritize.


  • Madison, New Jersey, United States Innova Solutions Full time

    Job Title: Clinical Trials Disclosure SpecialistInnova Solutions is seeking a highly skilled Clinical Trials Disclosure Specialist to join our team. As a Clinical Trials Disclosure Specialist, you will be responsible for providing operational support for the redaction of clinical trial documents in accordance with evolving global regulations.Key...


  • Madison, New Jersey, United States Mindlance Full time

    Job Title: Clinical Trials Disclosure SpecialistJob Summary:We are seeking a highly skilled Clinical Trials Disclosure Specialist to join our team at Mindlance. As a key member of our team, you will be responsible for providing operational support for clinical trial disclosure, including redaction of clinical trial documents in accordance with evolving...


  • Madison, New Jersey, United States LanceSoft Full time

    Job Title: Clinical Trials Disclosure SpecialistLanceSoft is seeking a highly skilled Clinical Trials Disclosure Specialist to join our team. As a key member of our team, you will be responsible for providing operational support for clinical trial disclosure, including redaction of clinical trial documents in accordance with evolving global regulations.Key...


  • Madison, New Jersey, United States Innova Solutions Full time

    Clinical Trials Disclosure Specialist Job DescriptionInnova Solutions is seeking a highly skilled Clinical Trials Disclosure Specialist to join our team. As a Clinical Trials Disclosure Specialist, you will provide operational support for the redaction of clinical trial documents in accordance with evolving global regulations.Key Responsibilities:Redact...


  • Madison, New Jersey, United States PSG Global Solutions Careers Full time

    Job Title: Clinical Trials ManagerJob Summary:We are seeking a highly skilled Clinical Trials Manager to join our team at PSG Global Solutions Careers. The successful candidate will be responsible for the execution and delivery of clinical trials, including clinical planning, regulatory affairs, and global drug safety.Key Responsibilities:Support the Sr....


  • Madison, New Jersey, United States PSG Global Solutions Careers Full time

    Job Title: Clinical Trial ManagerWe are seeking a highly skilled Clinical Trial Manager to join our team at PSG Global Solutions Careers. As a Clinical Trial Manager, you will be responsible for the execution and delivery of clinical trials in the pharmaceutical industry.Key Responsibilities:Support the Sr. CTM/operational study lead in collaborating with...


  • Madison, New Jersey, United States Bristol-Myers Squibb Full time

    Job SummaryAs an Associate Director, Alliance Management Lead at Bristol-Myers Squibb, you will play a critical role in managing clinical service providers and executing financial/legal agreements. This position requires strong interpersonal and communication skills, with the ability to manage cross-functional and multi-cultural teams. You will be...


  • Madison, New Jersey, United States PSG Global Solutions Careers Full time

    We are seeking a highly skilled Senior Clinical Supplies Management Specialist to join our team at PSG Global Solutions Careers. As a key member of our clinical development team, you will be responsible for developing and implementing the initial timeline, budget, drug supply forecasts, and component requirements needed for preparation of the Clinical...


  • Madison, New Jersey, United States Bristol-Myers Squibb Full time

    Job Summary:As an Associate Director, Alliance Management Lead at Bristol-Myers Squibb, you will play a critical role in coordinating with partner counterparts to ensure timely execution of the book of work while adhering to the MSA and Quality Agreement. This position requires strong interpersonal and communication skills to manage cross-functional and...


  • Madison, New Jersey, United States Better With Physical Therapy Full time

    Benefits of Working with UsWe offer a unique opportunity to work in a patient-centric environment where you can focus on delivering exceptional care to each individual patient.Our clinic prioritizes quality over quantity, ensuring that you have the time and resources to provide personalized attention to each patient.We believe in continuous learning and...


  • Madison, New Jersey, United States Innova Solutions Full time

    Job Title: Medical Project Manager - US HematologyJob Summary:Innova Solutions is seeking a highly skilled Medical Project Manager to join our team in the US Hematology department. As a Medical Project Manager, you will be responsible for facilitating medical matrix team meetings, ensuring the agenda is focused on key deliverables, risk management, issue...


  • Madison, New Jersey, United States Better With Physical Therapy Full time

    Benefits:We offer a unique opportunity for a Physical Therapist to join our team at Better With Physical Therapy, a PT-owned concierge outpatient orthopedic clinic at the Madison YMCA.Key Responsibilities:Provide one-on-one patient care, dedicating one hour to each patient to ensure exceptional outcomes.Collaborate with a team of Orthopedic Clinical...


  • Madison, New Jersey, United States PSG Global Solutions Careers Full time

    We're seeking a highly skilled Clinical Supply Chain Manager to join our team at PSG Global Solutions Careers. This role is ideal for a professional with experience in the pharmaceutical/device industry or CRO, looking to leverage their skills in clinical supply chain management.Key Responsibilities:Develop and implement effective supply chain strategies to...


  • Madison, Wisconsin, United States International Staff Consulting Full time

    Job Summary:This is a contract opportunity for a skilled Nurse - LPN or RN to join our team at a clinical research facility.Key Responsibilities:Preparing for upcoming studiesProviding care to a healthy population of patients during clinical trial studiesAdministering trial doses and monitoring side effectsDocumenting trial doses and effects into computer...


  • Madison, United States Exact Sciences Full time

    JOB REQUIREMENTS: Help us change lives At Exact Sciences, we\'re helpingchange how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life...


  • Madison, Wisconsin, United States MedTeam Staffing Full time

    Position Overview:Nurse - LPN or RN - Clinical Trials and Drug DevelopmentJob Summary:We are seeking a skilled and experienced Nurse to join our team at MedTeam Staffing. This contract opportunity offers a chance to work in a clinical research facility, preparing for upcoming studies and serving a healthy population of patients during clinical trial...


  • Madison, Wisconsin, United States MedTeam Staffing Full time

    Job Opportunity:This is a contract position with potential for permanent employment. Position Overview:Nurse - LPN or RNClinical Trials and Drug DevelopmentResponsibilities:Preparing for upcoming studiesProviding care to a healthy population of patients during clinical trial studiesAdministering trial doses and reporting side effectsRequirements:LPN or RN...


  • Madison, Wisconsin, United States University of Wisconsin Full time

    About the Role:The Division of Hematology, Medical Oncology and Palliative Care at the University of Wisconsin-Madison is seeking a skilled Gastrointestinal Medical Specialist to join our faculty. As a key member of our team, you will be responsible for delivering high-quality patient care, conducting research in gastrointestinal malignancies, and...


  • Madison, Wisconsin, United States Fortrea Full time

    Job Summary:Fortrea is seeking a highly motivated and detail-oriented Clinical Research Operations Specialist to support the success of our clinical trials. As a key member of our team, you will be responsible for coordinating logistical aspects of study operations, ensuring good study flow, and providing administrative support to senior study team...


  • Madison, United States CRU Fortrea Clinical Research Unit Inc. Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Madison, Wisconsin, United States U W-MADISON DIV. CONTINUING STUDIES Full time

    Job Summary: The Department of Human Oncology at the University of Wisconsin School of Medicine and Public Health is seeking a highly skilled Palliative Care Specialist to join our team. As a key member of our faculty, you will be responsible for providing radiation oncology clinical services with a primary focus on palliative radiation therapy. Your...


  • Madison, Wisconsin, United States U W-MADISON DIV. CONTINUING STUDIES Full time

    Job Summary:The Clinical Research Coordinator I/II position is within the Department of Medicine (DOM), in the School of Medicine and Public Health.This position involves coordinating clinical research trials for a variety of DOM clinical divisions and the UW Comprehensive Bleeding Disorders program.The primary duties of this job involve the management of...


  • Madison, Wisconsin, United States U W-MADISON DIV. CONTINUING STUDIES Full time

    Job Summary:The Department of Neurology at U W-MADISON DIV. CONTINUING STUDIES is seeking a highly skilled Clinical Research Coordinator II to join our actively growing clinical research team. The successful candidate will coordinate a variety of industry and PI-initiated clinical trials to advance discovery and research in the prevention, detection, and...


  • Madison, Wisconsin, United States Fortrea Full time

    Job Title: Clinical Research NurseAt Fortrea, we are seeking a dedicated Clinical Research Nurse to join our team. As a Clinical Research Nurse, you will play a vital role in conducting clinical trials and providing high-quality care to participants.Responsibilities:Conduct clinical trials and collect data in accordance with study protocols and regulatory...


  • Madison, Wisconsin, United States Actalent Full time

    Job Summary:We are seeking a Clinical Trials Dietary Assistant to join our team at Actalent. The successful candidate will assist with food preparation and dietary requirements per clinical trial protocols, as well as provide administrative support to the Clinical Operations Department.Key Responsibilities:Assist with food preparation and dietary...


  • Madison, Wisconsin, United States University of Wisconsin Hospitals and Clinics Authority Full time

    Job SummaryWe are seeking a highly skilled Clinical Nurse Specialist to join our team at American Family Children's Hospital. As a Clinical Nurse Specialist, you will provide clinical expertise and support to nursing staff, focusing on outpatient pediatric procedural and infusion care.Key ResponsibilitiesProvide clinical expertise and support to nursing...


  • Madison, Wisconsin, United States Fortrea Full time

    As a leading global contract research organization, Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development solutions across multiple therapeutic areas.We are seeking a Research Nurse to interact directly with healthy volunteer participants, learn to read clinical research protocols, and work in...


  • Madison, Wisconsin, United States UW Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Nurse Specialist to join our team at American Family Children's Hospital. As a Clinical Nurse Specialist, you will provide clinical expertise and support to nursing staff, focusing on outpatient pediatric procedural and infusion care. Your expertise will be invaluable in implementing customized...


  • Madison, United States FORTREA INC. Full time

    JOB REQUIREMENTS: As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With...


  • Madison, Connecticut, United States Actalent Full time

    Job Title: Clinical Care SpecialistJob Summary:The Clinical Care Specialist is an integral part of the clinical team, primarily responsible for providing safe, evidence-based care for patients, exceptional support, and the ability to anticipate the needs of both clinicians and patients.Key Responsibilities:Provide superior patient care in the Dermatology...


  • Madison, Wisconsin, United States Edwards Lifesciences Full time

    Job SummaryWe are seeking a skilled Clinical Sales Specialist to join our team at Edwards Lifesciences. As a Clinical Sales Specialist, you will be responsible for managing relationships with potential customers within an assigned territory, looking to establish a new market for our Advanced Patient Monitoring (APM) products in the Hospital Outpatient...


  • Madison, Wisconsin, United States UW Health Full time

    Job Title:Clinical Sleep SpecialistJob Summary:We are seeking a highly skilled Clinical Sleep Specialist to join our multidisciplinary health team. As an Advanced Practice Provider, you will play a vital role in providing comprehensive care to patients with sleep disorders.Responsibilities:Work collaboratively with physicians, other advanced practice...


  • Madison, Wisconsin, United States UW Health Full time

    Job Title: RN - Clinic SpecialistJob Summary: We are seeking a skilled RN to join our team at UW Health.Job Responsibilities:* Provide high-quality patient care as a Clinic RN* Collaborate with the healthcare team to ensure effective patient outcomes* Possess a current state license as a RN and have at least 2 years of recent experience as a Clinic RNWork...