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.
Position Summary Supports the CPLs and CTMs for business administrative tasks, especially for trial master file creation, maintenance, closure, and transfer for a single product and multiple studies per company or CRO SOPs. Handles centralized business process tasks, e.g., CDA generation, submission of insurance documentation, safety letter tracking, CSR appendix generation, patient safety cards procurement to support the study.
Principal Responsibilities

• Create, maintain, index and scan documents/files for all site related paper or electronic documents required in the TMF.
• Assists with ongoing review of the TMF and checks document compliance for active and archived projects.
• Ensure that project documents are maintained per relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs).
• User of systems and business technologies to document and track study and user progress.
• Serve as a content manager for study-specific internal work spaces.
• Procure, print and distribute patient safety cards in multiple languages for use across studies.
• Serve as CIOMS coordinator to track and update log of investigator letters against Investigator Brochure.
• Manage all Safety Reports in TMF and Investigator portal systems, including: QC, distribution and tracking.
• Coordinate delivery of documents to support registration of a protocol in ClinTrials.gov/EUdract and monitor its update throughout a study.
• Act as central point of contact for vendor providing this service.
• Enter, track and route contracts for legal input and approval using business systems and internal work spaces.
• Submit ereqs in the system for approval.
• Provide administrative support around meeting management, assembly of presentations for Investigator meeting and CRO/vendor kick-off meetings as required.
• Secure documents from the TMF that will be used in CSR appendices for CSR at study close-out.
• Upon site closure, prepares subject files, inventories documents, reconciles document discrepancies, and organizes study files for electronic archive and off-site storage.
• May attend cross functional meetings for initiatives in conjunction with the CoE.

Qualifications

• 2 year clinical research experience or course-work equivalent in clinical research.
• Strong verbal, written, and organizational skills with a team-oriented approach.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Proficiency in Microsoft Office Suite and email.
• Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired.

Education

• Bachelor\xe2\x80\x99s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable.

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 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.
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.