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Clinical Research Project Manager

2 months ago

Fort Worth, Texas, United States Intellectt Inc Full time

Position: Clinical Project Lead

Company: Intellectt Inc

Location: Fort Worth, TX (Onsite)

Overview:

  • Collaborate with the R&D Core Team to establish essential criteria for evaluating product safety, efficacy, and overall value.
  • Ensure that the design of clinical research programs aligns with scientific objectives and commercial requirements.
  • Collect insights from cross-functional teams to develop plans that facilitate timely deliverables.
  • Oversee the planning, direction, creation, and communication of clinical study timelines.
  • Guarantee that studies are conducted in accordance with clinical trial protocols.
  • Manage and resolve operational aspects of clinical trials in partnership with project teams, adhering to standard operating procedures (SOP), good clinical practice (GCP), and relevant regulations.
  • Engage in data analysis, interpretation, and synthesis to contribute to the development of clinical study reports and support scientific publications in collaboration with external key opinion leaders (KOLs).

Required Skills and Expertise:

  • Team Collaboration: Actively engage in and foster a collaborative team environment.
  • Project Management: Effectively manage studies to ensure adherence to timelines.
  • Effective Communication: Demonstrate strong written, verbal, listening, and presentation skills, conveying thoughts clearly and concisely while being attentive to others.
  • Serve as the primary contact for the Clinical Project Lead, supporting Life Cycle Management and Post Production Life Cycle Management activities.
  • Provide clinical functional review and expertise on assigned projects and tasks.
  • Responsible for timely authoring, revisions, and updates of clinical-related documents for Medical Device Regulation (MDR) remediation and Post Production Risk Reviews (PPRRs).
  • Review extensive documents such as literature reports and clinical research protocols as assigned.
  • Assist in literature review activities as needed.
  • Participate in Clinical team meetings and other project meetings as designated by the Project Lead.
  • Complete training to enhance understanding of the product therapeutic area as directed.
  • Preferably possess ophthalmic training.
  • Must have experience in clinical trials and research.
  • Regulatory experience and familiarity with EUMDR, including writing and reviewing, is advantageous.
  • Previous industry experience is beneficial.
  • Strong communication and writing skills are essential.