Oferty pracy: clinical data management

This position ensures that clinical study registrations and results are accurately routed, tracked, and entered into appropriate databases as per regulatory requirements and in line with Alexion principles, policies, and standards. This role will work globally with individual study teams to deliver redacted documents for regulatory submission under the EU Clinical Trial Regulation for Clinical Trial Information System postings (CTIS) and FDAAA801 with Final Rule for Clinicaltrials.gov postings. The role will advise internal users on access and retrieval of information and seek to maximize its value by integrating people, processes, and technologies. This position will function with moderate supervision as required, with dotted line reporting to AZ CTT leadership.

Principal Responsibilities

To support Alexion’s mission to improve the lives of people affected by rare diseases, the Medical Writing & Clinical Trial Transparency (MW&CTT) team drives the development of strategic and regulatory‑compliant documents to enable clinical research and regulatory approval of new therapies, and ensures Alexion’s continued compliance with laws, policies, regulations, and public commitments for transparency and disclosure.

CTT is responsible for posting clinical trial information to public websites and preparing clinical documents and data so they can be shared publicly to meet regulatory requirements and company commitments. This role ensures that the right tools and processes are used to effectively protect Alexion’s assets.

The Manager, Alexion CTT Registries & Redaction is expected to

• Manage and oversee applicable Alexion clinical study registrations and results, including ClinicalTrials.gov, EudraCT, trialsummaries.com, and all applicable tracking/routing internally or externally until final execution within the validated PharmaCM (Trialscope) system.
• Create redacted clinical documents following established Redaction Guidelines and SOPs.
• Perform quality control of redacted documents for peers, study teams, and local country staff.
• Demonstrate the ability to provide high-quality process documentation and to share knowledge with colleagues, building the overall community of practice.
• Demonstrate knowledge of clinical documents and the clinical study lifecycle.
• Demonstrate a high focus on quality and the ability to meticulously quality check work delivered.
• Demonstrate successful information management and data tracking.
• Maintain a high level of understanding of company policies and guidelines used to deliver to the regulatory policies and support protection of personal information.
• Support development of any training materials, when needed, in collaboration with direct manager.
• Ensure adherence to all applicable company requirements, including but not limited to clinical operations, quality, best practices in managing confidential business information, and data privacy.
• Work with a continuous improvement mindset, looking for opportunities to improve the process and increasing delivery efficiencies as this capability grows.
• Remain current on external regulations, guidelines, and best practices to learn new materials and bring them to the team in an implementable and repeatable way.
• Support the delivery of any CTT activities at Alexion as assigned.
• Work closely with study teams and leaders to support redacted document delivery per process.
• Understand regulatory requirements for EU CTR and FDAAA801 with Final Rule.
• Understand EMA updates to EU CTR Guideline.
• Support and communicate with study teams to secure delivery of redacted documents according to process.
• Professionally represent the group in response to queries for reports and metrics requests.

Required Qualifications:

• Competent verbal and written communication and collaboration skills in English.
• A proven track record of delivering with high quality against tasks that require attention to detail and focus
• Ability to manage concurrent activities.
• Understanding of clinical information and essential clinical trial documentation, including clinical trial applications, requests for information, and clinical trial amendments.
• Ability to understand and adhere to defined guidelines for identification of personal information accurately and demonstrate application across numerous documents.
• Basic understanding of what it means to identify something as company confidential information (CCI).
• Ability to work effectively in a global team with proven track record in collaboration with others for a shared delivery.
• Adobe Acrobat software experience and understanding.

Education

• Bachelor’s degree in life sciences or other relevant field.

Date Posted

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 accommodations@Alexion.com. Alexion participates in E-Verify.