Job Title
The Program Operations Leader is a senior role within the Clinical Trial Management team, responsible for overseeing the operational strategy and execution of complex programs in clinical research.
Job Description:
This individual will lead clinical operations activities, including quality, timelines, and budgets, ensuring compliance with applicable regulations, ICH/GCP regulations, and company Standard Operating Procedures (SOPs).
The Program Operations Leader will be a key member of the Clinical Trial Management extended leadership team, interacting with senior management, external vendors, collaboration partners, and clinical study personnel to drive clinical research project initiatives.
They will also oversee clinical trial management staff, including recruitment, development, coaching, mentoring, and performance management.
* Maintain an overview of clinical program status and issues
* Proactively communicate progress, risks, and changes to stakeholders
* Provide clinical program level updates as requested
* Oversight of clinical study timelines within a clinical program
In this role, you will work closely with cross-functional teams to develop and implement operational strategies that meet business objectives. You will also ensure consistency within the program and develop best practices within CTM.
You will be responsible for driving decision-making and integrating all operational considerations for studies within a clinical program to ensure goals are attainable prior to implementation.
Key Responsibilities:
* Lead clinical operations activities, including quality, timelines, and budgets
* Develop and implement operational strategies that meet business objectives
* Oversee clinical trial management staff, including recruitment, development, coaching, mentoring, and performance management
* Maintain an overview of clinical program status and issues
* Proactively communicate progress, risks, and changes to stakeholders
* Ensure consistency within the program and develop best practices within CTM
Requirements:
To succeed in this role, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations.
You should have excellent communication, project management, and leadership skills, with the ability to work effectively in a fast-paced environment.
What We Offer:
We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
We are an equal opportunity employer and welcome applications from diverse candidates.
About Us:
We are a leading company in the pharmaceutical industry, dedicated to improving human lives through innovation and excellence.
We are committed to creating a workplace culture that values diversity, inclusion, and employee well-being.