The Global Study Associate Manager (GSAM) is a role within Development Operations and is a member of the global study team supporting the delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of the Clinical Study Report (CSR), and study archiving.

The GSAM works with internal and external partners to deliver delegated aspects of the clinical study. Responsibilities include assisting global study teams, leading administrative activities, overseeing systems for compliance tracking, and providing support for vendor oversight.

Studies may be across various therapeutic areas and all phases (I–IV), (including Late Phase, Non-Interventional Studies, Post Authorization Safety Studies, Registries, Early Access Programs, And other study types)

You will be responsible for:

In collaboration with the global study team (GPD, GSAD, GSMs), other ARDU stakeholders, and key vendors, support activities for clinical study execution, ensuring adherence to timelines and quality standards.
Take a leading role in preparing study documents and documents related to key vendors, such as the Vendor Oversight Plan.
Actively maintain and facilitate interactions with cross-functional team members, including Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance.
Collaborate closely with both internal and external partners to effectively execute delegated aspects of the clinical study, ensuring alignment with the objectives set by the GPD, GSAD, or GSM.
Actively contribute to the planning and execution of both internal and external meetings.
Take a proactive role in identifying risks and issues and contribute to the development of mitigation and action plans.
Provide support to the GSM in project and budget management, adhering to agreed-upon delegation.
Actively participate in or take a leadership role in departmental initiatives and/or Subject Matter Expert (SME) functions.
Serve as a mentor and guide for team members, promoting their professional development and cultivating a collaborative work environment.
Provide support for other study and functional activities as assigned.

You will need to have:

Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development, or equivalent work experience.
Proficiency with technological systems, including Microsoft Office (Excel, PowerPoint, SharePoint Online), eTMF, and Veeva Systems.
Excellent organizational, communication, and time management skills.
Highly proactive and willing to take initiative.
Strong relationship-building skills.
The duties of this role are generally conducted in an office environment.

We would prefer for you to have:

More than 3 years of experience supporting global study teams in a clinical research environment.
Ability to drive discussions around the scope of work and oversee vendor-related activities.
Excellent knowledge of Essential Documents, CFR, and/or ICH-GCP.
Demonstrated ability to collaborate effectively while also working independently.
Project management skills and knowledge of basic project management methodologies.

Alexion is proud to be an Equal Employment Opportunity and Affemative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

Global Study Associate Manager

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