Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

The TMF Specialist serves in a key role for the execution of TMF Operations processes and strategy. Provides process subject matter expertise and support for TMF creation, maintenance, closure, and transfer per company and/or CRO SOPs and standards. Supports CRO and partners, TMF reporting and compliance. Provides support for Alexion TMF Operations and partner TMF operations representatives to resolve any issues identified with the TMF services delivered. Works with study teams and partners to help analyze vendor system and process changes and impact to applicable internal processes. Executes change management oversight to ensure consistent application of revised standards, processes, and systems functionality across study teams.

You will be responsible for:

• Executing and driving the day-to-day TMF activities for studies
• Assisting with establishing and maintaining TMF monitoring and reporting.
• Delivering KPI reports to study team, managing expectations, and tracking ongoing KPI across study team
• Providing best practice guidance and support to ongoing and ad-hoc TMF projects and initiatives.
• Assisting with TMF process education for internal & external TMF stakeholders
• Proactively staying current with best practices and recommends application across portfolio to continuously improve TMF operations processes.
• Leading projects in support of study or portfolio TMF objectives and attending standing cross functional meetings.

You will need to have:

• 3-5 years experience with clinical development processes.
• Foundational understanding of TMF
• 1-2 years TMF experience
• Knowledge/Understanding of the DIA Reference model
• Ability to multi-task and handle a multiple study workload
• Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity.
• Strong verbal, written, and organizational skills with a team-oriented approach.
• Familiarity with MS Office software including: Word, Excel, Outlook, Visio, Project, and PowerPoint.
• 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:

• Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable.
• Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired

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Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.