Trial Master File Tmf Process Specialist, Tmf Operations

30945
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.
The TMF Lead 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.
Leads and supports CRO and partnership migration and integration activities, 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.
Job Duties & Responsibilities

• Support integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices
• Mentor junior TMF positions within assigned portfolio
• Provides process and planning support the CTM and CPLs for TMF related remediation and process execution as needed
• Assist with CRO eTMF configuration testing as needed
• Delivers KPI reports to study team, manages expectations, and tracks ongoing KPI across study team in conjunction with the Clinical Trial Managers and Clinical Project Leads
• May manage or mentor junior staff members
• Assists with and deliver TMF process education efforts
• Assist with establishing and maintaining TMF monitoring and reporting
• Train internal/external study team and departments on TMF related expections, tools, processes, etc.
• Manage TMF portfolio level initiatives (i.e. process change/development) with CRO(s)
• Proactively stay current with best practices and recommends application across portfolio to continuously improve TMF operations processes
• Manage assigned portfolio TMF related ongoing activities (i.e. TMF QC schedule maintance, TMF storyboard maintenance)
• Ensure standards of compliance are adhered to across the portfolio and partnerships
• May lead projects in support of study or portfolio TMF objectives and attend standing cross functional meetings

Essential Qualifications

• Strong knowledge of Good Document Practice requirements & ALCOAC+ standards
• Strong verbal, written, and organizational skills with a team-oriented approach
• Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity
• 3-5 years experience with clinical development processes
• Ability to handle multiple projects on a regular basis
• Familiarity with MS Office software including: Word, Excel, Outlook, Visio, Project and PowerPoint

Preferred Qualifications

• Demonstrated individual and team leadership skills
• Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable
• 3+ year experience with Trial Master File
• Knowledge of TMF Reference model
• Experience with eTMF systems, preferably Veeva
• Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired

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 [email protected]. 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.