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About the Role

Support the delivery of cell therapy clinical studies, ensuring quality and compliance. This role requires flexibility as accountabilities will differ based on the clinical program or study. Contribute to the development of study documents, lead the preparation of country-specific agreements, manage third-party vendors, provide input to data management documents, and ensure the supply of study materials. Oversee third-party vendors, global/local internal staff, and investigator sites to support effective study delivery. Monitor study conduct and progress, support risk management and quality efforts, and assist in the implementation of audits and regulatory inspections.

Responsibilities

Support the delivery of cell therapy clinical studies
Ensure quality and compliance in clinical studies
Contribute to the development of study documents
Lead the preparation of country-specific agreements
Manage third-party vendors
Provide input to data management documents
Ensure the supply of study materials
Oversee third-party vendors, global/local internal staff, and investigator sites
Monitor study conduct and progress
Support risk management and quality efforts
Assist in the implementation of audits and regulatory inspections

Requirements

Bachelor’s degree with 4+ years of experience as a study manager
Experience of working with and delivering through strategic partners and 3rd party vendors
Excellent knowledge of ICH-GCP principles
Ability to lead, coordinate and prioritize multiple tasks and deliverables
Vendor Management experience
Proactive approach to achieving study goals
Demonstrated verbal and written communication skills
Good negotiation and collaboration skills
Demonstrated interpersonal and problem-solving skills
Ability to manage change with a high degree of flexibility
Some travel may be required

Skills

Vendor Management
ICH-GCP principles
Communication skills
Negotiation skills
Collaboration skills
Interpersonal skills
Problem-solving skills

Location

Gaithersburg, MD

Work Type

Full-time

Experience Level

4+ years of experience as a study manager

Education Level

Bachelor’s degree

Salary/Compensations

$112K to $168K

Benefits

Eligibility for various incentives
Short-term incentive bonuses
Equity-based awards for salaried roles
Commissions for sales roles
Qualified retirement programs
Paid time off (vacation, holiday, and leaves)
Health coverage
Dental coverage
Vision coverage

About the Company

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company.
We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases.
We are dedicated to being a Great Place to Work.
Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit.
To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
An inclusive culture where you will connect different thinking to generate new and valuable opportunities.
Where you will find a commitment to lifelong learning, growth and development for all.
Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.
Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We’re curious about science and the advancement of knowledge.
We find creative ways to approach new challenges.
We’re driven to make the right choices and be accountable for our actions.
As an organisation centred around what makes us human, we put a big focus on people.
Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential.
Here, you’ll do work that has the potential to change your life and improve countless others.
And, together with your team, you’ll shape a culture that unites and inspires us every day.
This is your life at AstraZeneca.

Equal Opportunity

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.
In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.