The Clinical Trials Disclosure Specialist I 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.
Essential Functions
- Performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (ie, 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 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 Client s 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 senior management. Escalates issues to senior management 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.
Educational Requirements:
- bachelors degree or higher, preferably in medical or scientific discipline.
Experience Requirements:
- 0-2 years of direct experience in disclosures and/or data transparency.
- CRO or Outsourcing experience preferred.
