Clinical Trial Secretariat Staff (SMA)
ちけんじむきょくたんとうしゃ（えすえむえー）
Industry & Occupation
Classification
Summary
Specialist position in pharmaceutical companies or CRO administrative departments handling support operations for clinical trials, document management, schedule adjustments, and data management.
Description
Clinical Trial Secretariat Staff (SMA) are specialists in pharmaceutical companies or CRO administrative departments who support clinical trial (clinical study) operations. They handle document management for clinical trial protocols, case report forms, informed consent forms, etc., subject schedule adjustments, data receipt and entry, quality control, monitoring support, and assistance with regulatory authority reporting. They collaborate with CRC and CRA to ensure accurate and efficient trial implementation based on GCP.
Future Outlook
With the globalization of the pharmaceutical industry and the increase in the number of clinical trials, demand for clinical trial secretariat staff is expected to rise steadily. While business efficiency improves with AI and RPA, regulatory compliance and communication tasks will still require human expertise, which will be highly valued.
Personality Traits
Attentive to details / Can act proactively / Has cooperativeness / Strong sense of responsibility
Work Style
Office Work / Project Contract / Regular Hours / Remote Hybrid
Career Path
Clinical Trial Secretariat Staff (SMA) → Clinical Trial Coordinator (CRC) → Clinical Development Monitor (CRA) → CRO Project Manager → Clinical Trial Consultant
Required Skills
Data Entry / Document Management / GCP / Schedule Management / Trial Protocol Understanding
Recommended Skills
CRO Experience / Communication Tools (Slack/Teams) / English Document Reading / Office Software / Project Management Tools
Aptitudes (Strengths Preferred)
| Item | Description |
|---|---|
| Attention to Detail & Accuracy | Because accuracy in data and documents is required. |
| Communication Skills | Because coordination with many stakeholders is required. |
| Learning Agility & Knowledge Acquisition | Continuous acquisition of specialized knowledge such as GCP and regulations is required. |
| Planning & Organization | Planning and adjustment of trial schedules and document management are important. |
| Collaboration & Teamwork | Because tasks are carried out in collaboration with CRC, CRA, etc. |
Aptitudes (Weaknesses Acceptable)
| Item | Description |
|---|---|
| Creativity & Ideation | Work mainly follows established procedures, and little new ideas are required. |
| Physical Stamina & Endurance | Because most work is desk work. |
Aliases
- SMA
- Site Management Associate
Related Jobs
- Clinical Development Monitor (CRA)
- Clinical Trial Coordinator (CRC)
- Medical Clerk