Adaptive Phage Therapeutics (APT) is a clinical-stage biotech advancing therapies to treat multi-drug resistant infections. We are on a mission to address today’s — and tomorrow’s — most challenging infections. We are looking for intelligent and motivated people to help us reach those goals.
The responsibilities of the Clinical Program Manager (unblinded) are geared toward 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. The role will liaise with blinded and unblinded staff to minimize potential errors and oversee investigational product supply and management. This position will manage all clinical supplies including ancillary supplies, and non-IP supplies. Responsibilities include creating & contributing to the development of study procedural documents and system development, oversight for activities regarding site pharmacy staff training, IP management, IP/dosing-related issues, unblinded Protocol Deviation (PD) escalation, and resolution, and monitoring pharmacy compliance with the protocol and study procedures (including unblinded monitoring visits). This position may support unblinded analyses and safety reviews and safety follow-ups and support eIND activities.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Ensure Unblinded study team processes are in place and training is developed and delivered, working with CRO, contractors, and internal APT staff.
Provide a single point of contact for routine support of unblinded CRAs, unblinded site staff, and unblinded study team members at APT; 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 APT 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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required for this job. Duties, responsibilities, & activities may change at any time with or without notice.
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; APT employees are required to be fully vaccinated against COVID-19 to work on the premises.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job and will be available to the candidate upon request.
APT is an Equal Opportunity/Affirmative Action employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. APT seeks to diversify its work force and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.