Clinical Trial Disclosure Specialist II

Propharma Group; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

Eine innovative Firma sucht einen Clinical Trials Disclosure Specialist II, um die Koordination und Entwicklung von Offenlegungsunterlagen zu leiten. In dieser spannenden Rolle sind Sie verantwortlich für die Registrierung und Pflege von Informationen auf öffentlichen Registern und die Qualitätssicherung von Dokumenten. Sie arbeiten eng mit internen Teams zusammen, um sicherzustellen, dass alle Anforderungen erfüllt werden und die Fristen eingehalten werden. Diese Position bietet die Möglichkeit, in einem dynamischen Umfeld zu arbeiten, in dem Ihre Fähigkeiten zur Verbesserung der klinischen Transparenz und zur Einhaltung von Vorschriften geschätzt werden.

Qualifications

• Mindestens 2 Jahre Erfahrung in der klinischen Studienoffenlegung.
• Fähigkeit, internationale Vorschriften und Richtlinien anzuwenden.

Responsibilities

• Koordination der Registrierung und Ergebnisse von klinischen Studien.
• Qualitätskontrolle von Dokumenten zur Einhaltung der Vorschriften.

Skills

Schriftliche und mündliche Kommunikationsfähigkeiten

Selbstmotivation

Zeitmanagement

Projektmanagement

Teamarbeit

Verständnis internationaler Vorschriften

Job description

Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures.

Job Description Summary

The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines.

Job Description

Essential Functions:

• Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable).
• Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations.
• Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents.
• Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations.
• Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner.
• Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking.
• Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner.
• Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues.
• Develops strong, lasting relationships with client teams that encourage organic new business growth.
• Other duties as assigned.

Necessary Skills and Abilities:

• Strong written and verbal communication skills.
• Self-motivated and able to work independently.
• Exceptional time management skills.
• Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries.
• A proven team player who can focus on and drive goal completion.
• Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency.
• Thinks proactively, takes initiative, and willingly takes on new challenges.
• Ability to identify areas of concern or inefficiency
• Works independently with good time management skills and contacts management team proactively when additional support and resources are needed.
• Works effectively in a collaborative team environment.
• Demonstrates a growth mindset and positive outlook in all work activities.
• Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.