Clinical Trials Operations Lead

AstraZeneca GmbH; Boston (MA); Hybrid; USD 83,000 - 124,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Retirement programs

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca GmbH is seeking a Clinical Study Administrator to support coordination of study activities from start-up through close-out. The role ensures quality, timeliness and cost efficiency in line with GCP, SOPs and regulatory requirements.

The CSA works with the PMCO, CRA, SSU manager, SML and HCO to deliver trial support across regions, maintaining eTMF, regulatory tracking, and milestone management in CTMS. Excellent collaboration and organization are essential.

Qualifications

• Bachelor's degree in a related discipline, preferably life science.
• Proficiency with MS Office Suite (Excel, Word, PowerPoint).
• Understanding of the drug development process either via education or experience in the life sciences field.
• Preferably minimum experience of 3 year in Development.
• Excellent collaboration and interpersonal skills, unafraid to ask questions.
• Strong organizational skills and ability to manage competing priorities.
• Strong attention to detail and effective written and verbal communication skills.

Responsibilities

• Coordinate trial activities from start-up to close-out to ensure quality, timing and budget alignment.
• End to end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone management in CTMS.
• Support start-up activities: CDA delivery and negotiation, distribution and collection of documents, site activation preparation.
• Collaborate with PMCO, CRAs, SSU manager and vendors on trial planning and logistics.
• Act as central point of contact for project communications and associated documentation.
• Input on development and maintenance of project management and global tracking tools (CTMS, Smartsheets).
• Collaborate in global initiatives to standardize processes across countries with CSAs.
• Assist with local language translations and IRB/CEC/CA submissions as required.
• Provide support for local COM meetings, travel logistics, and staff onboarding as needed.
• CSA may provide varying levels of COM support depending on country/region.

Skills

Collaboration

Organizational skills

Attention to detail

Written and verbal communication

Time management

Education

Bachelor's Degree in a related discipline

Tools

MS Office Suite

Job description

AstraZeneca GmbH is seeking a Clinical Study Administrator to support coordination of study activities from start-up through close-out. The role ensures quality, timeliness and cost efficiency in line with GCP, SOPs and regulatory requirements.

The CSA works with the PMCO, CRA, SSU manager, SML and HCO to deliver trial support across regions, maintaining eTMF, regulatory tracking, and milestone management in CTMS. Excellent collaboration and organization are essential.