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.
- 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 in Life Sciences (Ph.D., Pharm D, MS, RN, or similar scientific field preferred).
- 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.
- Proficient in Medical Terminology and medical writing skills.
- Domestic and international travel may be required (approximately 10-25%).