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Clinical Project Lead

3 months ago

Fort Worth, United States Intellectt Inc Full time

Role: Clinical Project Lead

Location - Fort Worth, TX (Onsite)


Description:

  • Work with R&D Core Team, establishing the criterion essential for determining the safety, efficacy, and value of products
  • Confirming clinical research program design meets scientific objectives and is aligned with commercial needs
  • Gathering input from cross-functional teams and creating plans that help the team produce deliverables on schedule
  • Planning, directing, creating, and communicating clinical study timelines
  • Ensuring study is conducted within clinical trial protocols
  • Overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations
  • Participating in data analysis, interpretation and synthesis, instruction in order to develop Clinical study report and /or support development of scientific publications including peer reviewed manuscripts in partnership with external key opinion leaders (KOLs)

Knowledge and Skills:

  • Collaborates – Actively participates in and supports a collaborative team environment.
  • Plans and Aligns – Effectively manage studies on schedule.
  • Communicates Effectively – Good written, verbal, listening and presentation skills with ability to express thoughts in a clear and concise manner. Attentively listen to others.
  • Act as the primary point of contact for the Clinical project lead and support in Life Cycle Management/Post Production Life Cycle Management activities
  • Provide clinical functional review and expertise on the assigned projects/tasks
  • Be responsible for timely authoring (as applicable), revisions, update, on clinical related documents for Medical Device Regulation (MDR) remediation and Post production Risk Reviews (PPRRs).
  • Review large documents such as literature reports, clinical research protocols, and review template documents as assigned by the project lead
  • Assist in literature review activities as assigned
  • Attend Clinical team meetings, and any other project meetings as assigned by the Project Lead and represent the function
  • Complete training activities to better understand product therapeutic area as assigned by the project lead
  • Strongly prefer ophthalmically trained,
  • Must have clinical trials / Research experience,
  • If possible, regulatory experience and EUMDR, writing and reviewing
  • Previous industry experience is also helpful
  • Strong communication and writing skills