Associate Study Manager

The Associate Study Manager will support the planning and execution of clinical studies under the guidance of the Study Manager within Clinical Operations. This role ensures adherence to study protocols, Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), FDA regulations/EU Directives, and ICH guidelines.

The primary focus is to provide clinical trial management support to study teams and to track CRO and vendor performance against project goals and milestones, ensuring compliance with organizational policies and expectations.

The Associate Study Manager will collaborate with internal and external stakeholders and multidisciplinary teams to advance clinical programs. Success in this role requires flexibility, creativity, and the ability to thrive in a rapidly growing environment.

A genuine commitment to addressing unmet medical needs—particularly within mental health—and a passion for supporting patients through innovative therapeutic approaches is essential.

CORE ACCOUNTABILITIES

The main objective of this role is to provide ongoing operational support for clinical studies. Responsibilities include, but are not limited to:

• Apply knowledge of the TMF Reference Model, including TMF set-up, maintenance, and archiving.
• Coordinate and reconcile periodic TMF quality and completeness reviews with internal teams and CRO partners.
• Assist with eTMF system administration (configuration, testing, study creation, user access, support, and training).
• Support audit and inspection readiness activities and manage documentation during regulatory inspections.
• Perform Central Monitoring oversight activities, including review of clinical and operational data to identify risk signals, monitor site performance, and ensure trial quality and integrity.
• Distribute key study documents to CROs and vendors.
• Provide clinical administrative support, including meeting logistics, agenda distribution, and minute preparation for study meetings and stakeholder interactions.
• Gather and coordinate information with Regulatory Operations for posting required trial information on public registries (e.g., ClinicalTrials.gov).
• Under supervision, review CRO-generated reports (e.g., monitoring visit reports, protocol deviation reports) and escalate concerns to the supervisor.
• Review and process investigator payments and vendor invoices.
• Compile and maintain monitoring review spreadsheets.
• Compile and maintain sponsor oversight/engagement visit reports.
• Analyze site performance metrics, identify areas of concern, and escalate findings appropriately.
• Track key study metrics (site start-up, site performance, recruitment, regulatory document collection, TMF QC activities) and communicate risks to the supervisor.
• Create and maintain tracking tools and spreadsheets as needed (e.g., vendor invoice trackers).
• Coordinate with insurance brokers or internal legal resources to obtain study site insurance.
• Provide tracking and oversight of vendors managing lab logistics and other study-related services.

Education and Experience

• Bachelor’s degree required.
• Minimum of 3 years of experience in the biotechnology/pharmaceutical industry supporting clinical projects or programs, with a strong understanding of overall study conduct.
• Knowledge of global regulatory and compliance requirements for clinical research (CFR, ICH, GCP).
• CRA experience preferred.
• Proficient in creating, reviewing, and supporting development of clinical study documents (e.g., ICFs, study manuals, forms, plans, templates).
• Demonstrated ability to maintain inspection-ready TMFs through ongoing audit activities and timely resolution of findings.
• Ability to work within an agile, collaborative team structure.
• Excellent communication (oral and written), organizational, interpersonal, and problem-solving skills.
• Ability to travel globally, including for conferences, site visits, and team meetings.