Clinical Study Manager

A Clinical Study Manager (CSM) is responsible for overseeing the planning, execution, and close of clinical trials to ensure they are successful and conducted in compliance with regulatory requirements, study protocols, and company standards.

Essential Duties and Responsibilities 

1. Study Planning and Design

• Scientific Background Research: Performs research to inform study design.

• Protocol Development: Collaborates with cross-functional teams and domain experts to develop clinical protocols.

• Feasibility and Site Selection: Conducts feasibility assessments and selects suitable clinical sites and investigators.

• Study Planning Support: Helps create and manage study budgets and timelines.

• Vendor Selection and Management: Identifies CROs, labs, and other vendors to be used in study.

2. Study Execution and Oversight

• Trial Management: Leads daily operations of assigned clinical studies, ensuring adherence to the protocol and regulatory requirements (e.g., GCP, ICH).

• Issue Resolution: Identifies risks or issues during the trial and implements corrective actions.

3. Cross-Functional Coordination

• Team Leadership: Leads and coordinates cross-functional study teams including Clinical Operations, Data Management, Biostatistics, Regulatory, and Safety.

• Meeting Facilitation: Organizes and leads study team meetings, ensuring clear action items and follow-ups.

• Regulatory Documentation: Coordinates the preparation and submission of documents to regulatory authorities (e.g., INDs, CTAs, amendments).

4. Data and Quality Management

• Case Selection: Works with data teams to identify criteria for cases and processes for collection.

• Data Review: Works with data teams to ensure timely and high-quality data capture, including QC / QA as needed.

• Audit and Inspection Readiness: Ensures the trial is always ready for audits or inspections by maintaining accurate and complete documentation.

5. Study Analyses and Close

• Data Analyses: Coordinate data analyses and review results

• Clinical Study Report (CSR): Supports preparation of the final clinical study report.

• Site Closure: Oversees close-out visits and site document archiving.

PLEASE NOTE:  This is not an exhaustive list of all duties, responsibilities and requirements of the position described above.  Other functions may be assigned and management retains the right to add or change duties at any time.

Minimum Qualifications, Education and Experience

• Bachelor’s degree in life sciences or related field (advanced degree preferred).

• Minimum 3-5 years of research experience, with at least 2 years in a study management role.

• Knowledge of ICH-GCP, FDA, EMA, and other relevant regulatory guidelines.

• Attention to detail and ability to manage multiple tasks

• Strong organizational and communication/collaboration skills

• Project management and leadership

• Communication and stakeholder management

• Conflict resolution, problem-solving and risk mitigation

• Familiarity with clinical trial management systems and related tools