Clinical Trial Transparency and Disclosure Specialist

The Clinical Trial Transparency and Disclosure Specialist position is responsible for the client project management activities and overall coordination, development, and quality oversight of multiple clinical trials disclosure 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 and client styles and formatting by all agreed upon timelines.

Essential Functions:

• With minimal supervision, acts as the primary point of contact for client-related operational activities associated with daily deliverables, managing client expectations along with interacting and communicating directly with clients.
• Responsible for the overall compliance and health of the project
• Performs/coordinates all activities for the registration, maintenance, and results postings, including document redaction for clinical trials across global registries including Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable.
• Ensures the development of high-quality registration, maintenance, and results deliverables that are compliant with all applicable policies, procedures, and regulations.
• Performs quality assurance review of registry, redaction, and plain language document deliverables, ensuring adherence to all applicable policies, procedures, and regulations, as well as any relevant client styles or guidelines.
• Works closely with the internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations.
• Works with the internal Client team(s) to ensure the source information is provided for clinical trials 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 medical writing leadership. Makes decisions regarding issue resolution.
• 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.
• Provides mentorship and guidance to other team members, as needed.
• Develops strong, lasting relationships with client teams that encourage organic new business growth.
• Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to clinical trials disclosure and/or data transparency.
• Understands budget specifications for assigned deliverables, works within budgeted hours, and communicates out-of-scope tasks to medical writing leadership.
• Other duties as assigned.

Necessary Skills and Abilities:

• Advanced knowledge, understanding, and application of global clinical trials disclosure guidelines and regulations.
• Exceptional project management skills and strong communication skills with a high attention to detail and quality.
• 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.
• Strong experience in relationship building and strategic collaboration on key business accounts.
• Thinks proactively, takes initiative, and willingly takes on new challenges.
• Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.  
• Works independently with exceptional time management skills and contacts the 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 trial disclosure and/or data transparency.

Educational Requirements:

• Minimum of bachelor's degree in a related field (scientific field preferred).

Experience Requirements:

• Minimum of 5+ years of direct experience in clinical trial disclosure and/or data transparency.
• CRO or Outsourcing experience preferred.