Trial Disclosure Associate

Location: Remote (US)

Contract Length: Through end of 2024

Pay Rate: $38-43/hr

Responsibilities:

• Responsibilities will be focused on supporting EU CTR applications and documentation. Familiarity with clinical study and site start up documentation is preferred.
• Responsibilities will vary based upon business need. May support global study registrations, writing scientific study results, protocol/result lay summaries, or anonymizing clinical documents for public disclosure by regulatory agencies.
• Completes activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
• Communicates deliverables, process and timelines effectively across functional areas and within department to accomplish project objectives.
• Coordinates the review, approval, and other appropriate functions.
• Identifies conflicts and resolves or elevates them to management to ensure resolution.
• Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
• Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
• Continually trains/is compliant with all current SOPs & work instructions

Experience / Qualifications:

• Bachelor's degree required, preferably in a health or biological science field
• 2-4 yrs experience in clinical trial registries, regulatory agency transparency or drug development with a clinical research, quality or regulatory background, preferably in a pharma environment
• Project management experience preferred
• 2 years of writing experience preferred
• Attention to detail. Find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
• Ability to shift daily priorities, meet deadlines, ask questions
• Proficient with major Microsoft suite programs and other pharma systems
• Works well in a global, team environment

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.