The Associate Clinical Study Manager (ACSM) supports the planning, execution, and oversight of clinical trials to ensure studies are conducted in compliance with study protocols, company SOPs, and regulatory requirements. This role works closely with cross-functional teams, clinical sites, and vendors to ensure high-quality clinical trial delivery aligned with timelines and budgets.
Key Responsibilities
Clinical Trial Execution:
Support the Clinical Study Manager in planning, implementing, and managing clinical trials.
Study start-up activities including site selection, feasibility assessments, and site initiation.
Track study progress, including patient enrollment, milestones, and timelines.
Monitor study performance metrics and escalate risks or delays.
Site & Vendor Management:
Serve as a point of contact for Clinical Research Associates (CRAs) and investigative sites.
Support management of contract research organizations (CROs), central labs, and other vendors.
Track vendor deliverables and ensure services meet study requirements.
Study Documentation & Compliance:
Maintain and review essential study documentation within the Trial Master File (TMF).Ensure compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs. Assist in preparing documentation for regulatory submissions and audits.
Cross-Functional Collaboration:
Coordinate with internal teams such as Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.
Support preparation for investigator meetings and study team meetings.
Provide status updates and reports to internal stakeholders.
Risk & Issue Management:
Identify study risks and assist in developing mitigation strategies.
Track protocol deviations, study issues, and corrective actions.
Support inspection readiness for regulatory authorities.
Qualifications:- EducationBachelor’s degree in life sciences, nursing, pharmacy, or related scientific discipline.
- Experience3–5 years of experience in clinical research, typically as:
- Clinical Research Associate (CRA)
Clinical Trial Associate (CTA):- Clinical Project Coordinator
- Experience working in biotechnology, pharmaceutical companies, or CROs.
- SkillsStrong knowledge of clinical trial processes and GCP regulations.
- Experience with clinical trial management systems (CTMS) and electronic Trial Master File (eTMF) systems.
- Strong organizational, project coordination, and communication skills.
- Ability to manage multiple priorities in a fast-paced biotech environment.
