Program Manager, Clinical Operations

The Clinical Operations Program Manager focuses on Clinical Operations (CO) study execution responsibilities, and may take on a specified number of additional functional management and/or infrastructure responsibilities. Alternatively, a Manager may have a dedicated infrastructure Manager role. 

As a Lead Study Manager, he/she would be the CO lead for day-to-day CO functional activities associated with the execution of clinical trials. Responsible for the oversight of the CO team, Clinical Research Organizations and third party vendors. Responsible for escalating CO study issues and risks. 

As a dedicated Infrastructure Manager, he/she will have leadership and/or oversight of sub­teams of the wider CO group, such as Clinical Business Operations, eClinical, Resource Capacity Planning, Data Management, Outsourcing, Training, Quality, Standards, Processes, and other initiatives. May also lead department, development or cross-functional initiatives. 

PRIMARY RESPONSIBILITIES: 

•    Lead all day-to-day CO study activities - start-up, maintenance and close-out
•    Serve as the standing Study Execution Team (SET) member representing CO
•    Approve and maintain study plans
•    Contribute to detailed SET timeline and execute CO responsibilities
•    Responsible for identifying and escalating issues and risks to the SET Lead, as appropriate
•    Manage CO Clinical Research Organization (CRO) vendor
•    Oversee the management of specialty vendors, including budget(s) and coordinate periodic CRO and other vendor reviews
•    Oversee Informed Consent Form template development
•    Review electronic Case Report Form and CO user acceptance testing
•    Execute study quality metrics actions
•    Accountable for enrollment stimulus strategies
•    Responsible for the coordination of data review activities required of the CO team member(s); collaborate with the Statistical Analysis and Reporting Team
•    Manage protocol deviation review - preventive action planning, immediate escalation of significant concerns to SET Lead and Medical Monitor
•    Provide clinical supply projections, approve clinical supply demand, and lxRS user acceptance training
•    Lead one or more major departmental infrastructure area(s) such as Resourcing, Training, or Quality, Standards and Process (QSP)
•    Manage all elements of the infrastructure area from planning, resourcing, implementation and continuous improvement
•    Assist team members with tasks that are outside normal work responsibilities, as needed

FUNCTIONAL INFRASTRUCTURE & ADDITIONAL RESPONSIBILITIES:

•    Create and maintain department SOPs
•    Coordinate and participate in Investigator Meetings
•    Collaborate with department members to identify process optimization / best practices and lessons learned within Clinical Operations
•    Ensure compliance with Aptose SOPs and guidelines, FDA regulations, and current International Conference on Harmonization - Good Clinical Practices

REQUIRED EDUCATION & WORK EXPERIENCE:

•    Master's degree & a minimum of 4 years related experience, OR
•    Bachelor's degree & a minimum of 6 years related experience

PREFERRED QUALIFICATIONS:

•    Master's or Bachelor's degree in nursing, health or life sciences field
•    8 years of Biopharmaceutical clinical research experience (working on clinical trials at a biotech, pharmaceutical or CRO)
•    Experience in Hematology/Oncology (preferably non-solid tumor) clinical trials
•    Experience managing clinical research vendors (CROs, Central Labs, Imaging, etc.)

FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS:

•    Proficient in Microsoft Office (Word, Excel, Power Point and Project)
•    International Conference on Harmonization - Good Clinical Practices
•    Drug Development
•    Technology
•    Trial Execution
•    Regulatory Environment
•    Process, Procedures and Best Practices

COMPETENCIES:

•    Collaborate
•    Communicate effectively in English, oral and written
•    Deliver on commitments
•    Maintain composure
•    Proactively plan and organize
•    Solve problems
•    Adapt
•    Be self-aware
•    Detail oriented and meticulous follow through
•    Manage and improve process
•    Facilitate
•    Influence and persuade
•    Lead
•    Manage and develop people

TRAVEL REQUIREMENTS:

•    Up to 50%, as needed