Unblinded Clinical Program Manager

Proclinical is seeking an Unblinded Clinical Program Manager located on the East Coast, USA with a clinical-stage biotech company. In this role, you will be supporting the protection and maintenance of the study blind. This role is structured to enable issue resolution, avoid accidental unblinding events, and mitigate regulatory risks.

Job Responsibilities:

• Ensure Unblinded study team processes are in place and training is developed and delivered, working with CRO, contractors, and internal staff.
• Provide a single point of contact for routine support of unblinded CRAs, unblinded site staff, and unblinded study team members; this includes system issues, patient dosing issues, and other questions.
• Track and document potential/actual unblinding events to completion
• Oversee Clinical Supply Operations to ensure prompt resolution of regarding any supply issues and ensure adequate supply for study sites per relevant SOPs and study plans - this will include both blinded and unblinded clinical supplies
• Consult with Unblinded and CRO staff regarding safety and dosing issues. If necessary, consult with Medical Monitor in a blinded fashion regarding safety & dosing issues.
• Review Unblinded Site Monitoring Visit Reports. Advises Unblinded Site Monitors, in collaboration with on-site protocol deviation documentation and follow-up. Conduct on-site monitoring/ co-monitoring visits as required
• Assists in Risk-Based Monitoring review and analysis related to protecting study blinding
• Review randomization and/or IVRS specifications and ensure system accuracy and process compliance
• Participate in team meetings as assigned to escalate issues and discuss lessons learned
• Ensures proper study document flow and sequestration before study unblinding timepoints and end of the study to ensure maintenance of blind.
• Facilitates drug transfer, return, and destruction at site closure
• Assist in Investigational Product reconciliation at database lock, interim analyses, and other unblinding activities requiring reconciliation including ongoing monitoring activities
• Support the audit response team for findings related to blinded Investigational Product
• All other duties as assigned. This position will support Clinical Operations staff when unblinded activities and supply management activities are not required.

Skills and Requirements:

• Degree/Certification/Licensure - Bachelor's degree required preferably within life sciences or equivalent.
• At least three years of site monitoring experience
• Experience as an unblinded site monitor required
• Knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.
• Knowledge and understanding of clinical research processes, regulations, and methodology
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
• Organization and time management skills.
• Ability to build, maintain and strengthen relationships even under pressure and in difficult situations
• Good verbal and written communication skills (both in English and local language)
• Proficiency with Microsoft Office Suite
• experience with Clinical Trial Management Systems(CTMS) and Electronic Data Capture Systems (EDC)
• Full COVID-19 vaccination required; employees are required to be fully vaccinated against COVID-19 to work on the premises.

If you are having difficulty in applying or if you have any questions, please contact Ashley Dermott at (+1) 570-277-7059 or A.Dermott@proclinical.com.

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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