Trial Disclosure Associate

Description

Title: Trial Disclosure Associate

 Manager's update 

• PhD or Doctorate degree would be overqualified for this role
• 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.
• Must be proactive and able to work the assigned duties.
• Need to do the QC document before it will be going to publish in the public domain
• Must have a Bachelor's degree (Science/Life Sciences specialization)
• Able to collaborate with CRA professionals
• Must have 2-4 years of experience
• Looking for clinical registry and registration experience
• Preferred to have study start-up documentation experience
• Must have a clinical documentation experience
• Must have clinical trials experience
• Able to work with clinical studies in a public domain
• Must have eTMF experience
• Must have an attention to detail/Detail Oriented professional/Task oriented
• Able to process the study documents
• Eager to learn kind of professionals are required for this role
• Able to work independently
• Completes activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
• Prior clinical trials associate or clinical trial lead with QC documentation, eTMF and trial registry experience would be considered as good fit for this role.

Responsibilities:

• 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

Experience Level = 5-7 Years