Clinical Project Manager

Proclinical is currently recruiting for a Clinical Project Manager with a biopharmaceutical company located in Chicago, IL.

Job Responsibilities:

• Develops and Drives operational study-level strategy to be executed by CSM Country teams, including risk identification, evaluation, and mitigation to establish alignment with overall study execution. Identifies risk to CSM deliverables and effectively communicates them within CSM (global, area and regional level) and to the Core Study Team. Manages identified risk through development of effective mitigation and action plans at study-level. Works with ASML, Country Leaders and other functional areas, as appropriate, to drive implementation of mitigation and action plans.
• Member of the Core Study Team, representing CSM globally from study planning through study closeout. Actively contributes to planning and execution of the clinical programs including content of the protocol and study plans (e.g. IDRP, RAMP, Recruitment Strategy and Plan). Provides input into vendor selection and content of site-facing vendor platforms.
• Accountable for CSM study execution and oversight of timeline development and adherence through the study lifecycle. Includes working with CSM country leadership to ensure LBEs meet overall study timelines and, if not, establishing a risk mitigation plan for discussion with the study team and ensuring all participating countries are informed and aligned to the overall timelines for the study.
• Partners with stakeholders (Clinical Study Leadership, Study Performance & Delivery, CTRG, DSS, CDSM and CSM Country leaders, etc.) in developing overall study planning for CSM deliverables and dependencies, using analytics and country intelligence to enhance the Country and Site selection process. Ensures CSM Country leaders receive appropriate and timely study information, documentation and tools to allow for plans to be executed as per targeted milestones.
• Accountable for driving site management activities from study start-up through study closeout ensuring delivery of site selection/activation, subject recruitment, protocol compliance, data quality and adherence to monitoring plan.
• Provides the perspective of the CSM organization, investigators, and patients, for the development of study documents, including, as applicable, CRA training delivery plans and materials, site staff and patient facing material.
• Accountable for site-level risk assessments, risk mitigation execution and remediation of site-level non-compliance.

Skills and Requirements:

• Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field.
• A minimum of 5 years + of industry clinical research experience including 1 year of monitoring or project management or equivalent experience on a global study.
• Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients). Experience in multiple therapeutic areas or disease state/indications highly desired.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280. 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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