Astrazeneca

Healthcare

GlobalStudyManager

$0–0k Gaithersburg, Maryland, United States FULL TIME
The Brief

“Global Study Manager at Astrazeneca. Skills: Study management, Vendor management, ICH-GCP principles. Support delivery of clinical studies. Ensure quality and compliance”

Industry & Context.

Healthcare
Problems you'll solve

Problem-solving skills

Eligibility Requirements

Some travel may be required

What They're Looking For.

Must Have

Bachelor's degree, 4+ years study manager experience, Experience with strategic partners, Experience with 3rd party vendors, Knowledge of ICH-GCP principles, Ability to lead tasks, Ability to coordinate tasks, Ability to prioritize tasks, Vendor Management experience, Demonstrated communication skills, Demonstrated negotiation skills, Demonstrated collaboration skills, Demonstrated interpersonal skills, Demonstrated problem-solving skills, Ability to manage change, High degree of flexibility

Nice to Have

Early/late phase oncology clinical trial experience, Experience in autologous therapies, Experience in allogeneic therapies, Clinical Study Management experience

What You'll Do.

Support delivery of clinical studies

Ensure quality and compliance

Contribute to development of study documents

Lead preparation of country-specific agreements

Manage third-party vendors

Provide input to data management documents

Ensure supply of study materials

Oversee third-party vendors

Oversee global internal staff

Oversee local internal staff

Oversee investigator sites

Support effective delivery of study

Monitor study conduct

Monitor study progress

Support risk management

Support quality efforts

Assist implementation of audits

Assist implementation of regulatory inspections

How You'll Work.

Team & Collaboration

Global internal staff; Local internal staff; Investigator sites

Communication Scope

Verbal communication; Written communication

Process & Methodology

Study management

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