This is what you will do:
The Global Study Associate Manager (GSAM) is a role within Development Operations and is a member of the global study team supporting delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The GSAM works with internal and external partners to deliver delegated aspects of the clinical study and 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, Post Authorization Safety Studies, Registries, Early Access Programs, etc.).
You will be responsible for:
In collaboration with the global study team (GPD, GSAD, GSM's), 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 commensurate work experience. Proficiency with technological systems (Microsoft Office such as: Excel, PowerPoint, and 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. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
3+ years 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 as well as work independently. Project management skills and basic PM methodology. Date Posted: 03-Oct-2024
Closing Date:
Alexion is proud to be an Equal Employment Opportunity and Affirmative 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 lack thereof, sex, sexual orientation, 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 . Alexion participates in E-Verify.
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