Clinical Study Associate Manager

About the role

May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with global study plans, and may contribute to global planning and management of the study.

Contributes to risk assessment and helps identify risk mitigation strategies, and supports feasibility assessment to select relevant regions and countries.

Oversees and provides input to the development of study specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan) and reviews site level informed consents and other patient-facing study start-up materials.

Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution.

Oversees engagement, contracting and management of required vendors for the study, and oversees and provides input to study drug and clinical supplies' forecasting, drug accountability and drug reconciliation.

Provides regular status reports to collaborators as requested by the Clinical Study Lead, and contributes to development of and oversees implementation of recruitment and retention strategies.

Makes sure recruitment and retention are monitored, and 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, and escalates data flow and data quality issues to Clinical Study Lead.

Ensures the execution of the specific clinical study deliverables against planned timelines, escalates issues related to timelines or budget to Clinical Study Lead, and supports accurate budget management and scope changes.

Contributes to clinical project audit and inspection readiness throughout the study lifecycle, and supports internal and external inspection activities and contributes to CAPAs as required.

Manages aspects of study close-out activities including database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability, may mentor clinical trial management staff, and may be assigned unmasked tasks for studies (e.g., unmasked TMF management, unmasked data review, IVRS point of contact).

Responsibilities

• May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with global study plans, and may contribute to global planning and management of the study.
• Contributes to risk assessment and helps identify risk mitigation strategies, and supports feasibility assessment to select relevant regions and countries.
• Oversees and provides input to the development of study specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan) and reviews site level informed consents and other patient-facing study start-up materials.
• Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution.
• Oversees engagement, contracting and management of required vendors for the study, and oversees and provides input to study drug and clinical supplies' forecasting, drug accountability and drug reconciliation.
• Provides regular status reports to collaborators as requested by the Clinical Study Lead, and contributes to development of and oversees implementation of recruitment and retention strategies.
• Makes sure recruitment and retention are monitored, and 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, and escalates data flow and data quality issues to Clinical Study Lead.
• Ensures the execution of the specific clinical study deliverables against planned timelines, escalates issues related to timelines or budget to Clinical Study Lead, and supports accurate budget management and scope changes.
• Contributes to clinical project audit and inspection readiness throughout the study lifecycle, and supports internal and external inspection activities and contributes to CAPAs as required.
• Manages aspects of study close-out activities including database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability, may mentor clinical trial management staff, and may be assigned unmasked tasks for studies (e.g., unmasked TMF management, unmasked data review, IVRS point of contact).

Requirements

• Bachelor's Degree and 4+ years of relevant industry experience.
• Excellent communication and interpersonal skills; ability to build relationships internally and externally.
• Data driven approach to executing and problem solving, and attention to details for the ability to deliver on specific study activities.
• Technical proficiency in trial management systems and MS applications including Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF.
• 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.
• Familiarity with medical terms, and vendor management experience.
• Experience in clinical trial operations including experience developing key study documents.
• Knowledge of ICH/GCP and regulatory guidelines/directives.

Qualifications

• None specified

Skills

• Excellent communication and interpersonal skills.
• Data driven approach to executing and problem solving.
• Technical proficiency in trial management systems and MS applications.
• Proactive and self-disciplined.
• Budget awareness.
• Familiarity with medical terms.
• Vendor management experience.
• Experience in clinical trial operations.
• Knowledge of ICH/GCP and regulatory guidelines/directives.

Benefits

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits (e.g. medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

Pay

$109,900.00 - $179,300.00 annually

Schedule

Hybrid: 4 days per week onsite