Clinical Study Associate Manager

Responsibilities

The Clinical Study Associate Manager role supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery.

Travel to study sites may be required to assist with supervising clinical studies.

Oversee management of a clinical study in an assigned region

Contributes to risk assessment and helps identify risk mitigation strategies

Supports feasibility assessment to select relevant regions and countries

Provide 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

Manage creation and maintenance of study systems including Clinical Trial Management System (CTMS) and Trial Master File (TMF)

Is responsible for appointment, contracting and management of required vendors for the study

Provides input to study drug and clinical supplies' forecasting, drug accountability and drug reconciliation

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

Skills & Requirements:

• Excellent communication and interpersonal skills; ability to build relationships internally and externally
• A data driven approach to executing and problem solving
• Attention to details for the ability to deliver on specific study activities
• Technical proficiency in trial management systems and MS applications including (but not limited to) 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
• Vendor management experience

If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at 02074400639

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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