Full Time
Posted 1 month ago

Position Summary & Objectives

  • Responsible for implementation, planning, and execution of assigned clinical trial activities.
  • Successfully leads, plans, and executes trial-level activities for multiple trials with minimal to moderate level of supervision.

Position Responsibilities

  • Manage protocol and ICF development process (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, adjudication/resolution of cross-functional comments, and ensuring high clinical quality in collaboration with medical writing.
  • Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses)
  • Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members.
  • Plan and lead the implementation of clinical study startup/conduct/close-out activities as applicable
  • Serve as primary contact for site-facing activities such as training and support for clinical questions.
  • Conduct and oversee data generation and validation activities, including CRF design, clinical data review/query resolution; ensure consistent, quality data review.
  • Identify clinical data trends, provide trends, and escalate questions to study physician.
  • Provide information required by Protocol Manager to develop the trial budget, CRO scope of work, etc.
  • Collaborate and serve as primary liaison between external partners for scientific advice.
  • Author/review abstracts, presentations, and manuscripts for external publications.

Degree Requirements

  • Degree in Life Sciences (Ph.D., Pharm D, MS, RN, or similar scientific field preferred).

Experience Requirements

  • 3+ years of experience in clinical science, clinical research, or equivalent.
  • Experience in PTSD, depression studies is preferred.
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
  • Proficient knowledge and skills to support program-specific data review, trend identification, data interpretation.
  • Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.

Key Competency Requirements

  • Excellent verbal, written, communication, and interpersonal skills.
  • Must be able to communicate and collaborate across functions and job levels effectively.
  • Ability to assimilate technical information quickly.
  • Routinely takes the initiative.
  • Detail-oriented.
  • Proficient in Medical Terminology and medical writing skills.

Travel Required

  • Domestic and international travel may be required (approximately 10-25%).

Job Features

Job Category

Business Development

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