Associate Clinical Study Manager

Advanced Recruiting Partners; United States; On-site; USD 85,000 - 120,000; Full time

Job summary

Advanced Recruiting Partners is seeking an Associate Clinical Study Manager (ACSM) to support planning, execution, and oversight of clinical trials, ensuring compliance with protocols, SOPs, and regulatory requirements.

You will collaborate with cross-functional teams, CRAs, sites, and vendors to manage timelines, enrollment, budgets, TMF accuracy, and regulatory submissions, while contributing to inspection readiness and risk mitigation.

Qualifications

• Strong knowledge of clinical trial processes and GCP regulations.
• Experience with CTMS and electronic Trial Master File (eTMF) systems.
• Excellent organizational, project coordination, and communication skills.
• Ability to manage multiple priorities in a fast-paced biotech environment.

Responsibilities

• Support planning, implementing, and managing clinical trials.
• Oversee site selection, feasibility, and site initiation.
• Track enrollment, milestones, and timelines.
• Monitor study performance metrics and escalate risks.
• Serve as a liaison with CRAs, sites, CROs, and vendors.
• Maintain TMF and assist in regulatory submissions and audits.
• Provide status updates to internal stakeholders.
• Support inspection readiness for regulatory authorities.

Skills

Clinical trial processes & GCP

CTMS & eTMF experience

Organizational & project coordination

Communication skills

Biotech/pharma/CRO experience

Education

Bachelor’s degree in life sciences, nursing, pharmacy, or related discipline

Tools

CTMS

eTMF

Job description

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.
• 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.
• Identify study risks and assist in developing mitigation strategies.
• Track protocol deviations, study issues, and corrective actions.
• Support inspection readiness for regulatory authorities.

Qualifications

Education

• Bachelor’s degree in life sciences, nursing, pharmacy, or related scientific discipline.

Experience

• 3-5 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.

Skills

• Strong 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.