kps life · 18 hours ago
Clinical Study Associate Manager (CSAM)
Cambridge, MA
Full-time
Hybrid
Mid, Senior Level
4+ years expKPS Life is a company that supports clinical trial delivery through its Clinical Study Associate Manager (CSAM) Service. The CSAM works with both internal study teams and external vendors to ensure the successful planning, initiation, and management of clinical studies in compliance with regulatory standards and company SOPs.
Health CareMedicalWellness
Responsibilities
May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study
Contributes to risk assessment and helps identify risk mitigation strategies
Supports feasibility assessment to select relevant regions and countries
Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc
Reviews site level informed consents and other patient-facing study start-up materials
Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution
Oversees engagement, contracting and management of required vendors for the study
Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation
Provides regular status reports to stakeholders as requested by the Clinical Study Lead
Contributes to development of and oversees implementation of recruitment and retention strategies
Monitors progress for site activation and monitoring visits
Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites
Escalates data flow and data quality issues to Clinical Study Lead
Oversees the execution of the specific clinical study deliverables against planned timelines
Escalates issues related to timelines or budget to Clinical Study Lead
Supports accurate budget management and scope changes
Contributes to clinical project audit and inspection readiness throughout the study lifecycle
Supports internal and external inspection activities and contributes to CAPAs as required
Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability
May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
Qualification
Required
Bachelor's degree and minimum 4 years of relevant experience
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
Knowledge of ICH GCP and relevant regulatory guidelines/directives
Demonstrated interpersonal & leadership skills
Attention to details for the ability to deliver on specific study activities
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Budget awareness with the ability to participate in various aspects of budget management
Effective communication skills via verbal, written and presentation abilities
Company
kps life
KPS Life is a functional service solution that improves efficiency, lowers trial costs, and gives the sponsor strategic control.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$3.5M2025-06-11Undisclosed· $3.5M
2021-02-26Debt Financing
2021-01-12Private Equity
Leadership Team
Kevin Duffy
Chief Commercial Officer
Recent News
2023-06-05
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