Clinical Data Manager III

Alexion Pharmaceuticals
Employment Type
Not disclosed
Alexion Pharmaceuticals logo

Some opportunities happen only once in a lifetime – like a job where you have the chanceto 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:

A Senior Clinical Data Manager (SrCDM) (Level CDMIII) has keen attention to detail and is responsible for leading and supporting the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. SrCDMs support multiple, high volume, and highly complex studies within a development program. The individual will perform various complex tasks to ensure complete, accurate, high quality, and regulatory compliant data supporting publications and regulatory submissions.

You will be responsible for:

  • Acting as the primary or supporting data manager responsible for study-specific study start-up tasks, including case report form (CRF) design, edit check creation, CRF completion guideline (CCG) creation, and user acceptance testing including leading process improvements and enhancements, as needed.
  • Participating in and leading data validation tasks for various studies during maintenance and close-out, focusing on data integrity and quality metrics.
  • Participating in and leading the development and maintenance of the data management plan (DMP).
  • Participating in or leading ongoing operational support for all activities, and at times leading specific projects or tasks, during clinical trial conduct, including database migrations, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, and support for database lock and archiving activities.
  • Ensuring that medical coding is completed quickly, completed for all data cuts, and reviewed and approved by medical monitors.
  • Ensuring that user administration in data management-owned systems and Trial Master File document filing is accurate and timely.
  • Independently monitor activities and project status for successful project deliverables according to the timeline while participating in initiatives to streamline data management processes.

You will need to have:

  • A Bachelor’s degree in a scientific discipline or equivalent.
  • Relevant experience in clinical data management for 4+ years; or equivalent experience at a hospital or research site with knowledge of medical terminology and experience defining, entering, processing, reviewing, and validating clinical data.
  • Highly effective written and verbal communication skills to interact professionally with personnel at all levels within and outside of the company while being a dependable team player.
  • Utilizing skills and experiences to guide initiatives using sound judgment and flexible design while balancing effective time management and organizational skills and being capable of working under challenging timelines in multi-player environments.
  • Organizational skills demonstrating the ability to work on multiple projects simultaneously while independently managing responsibilities with effective time management and impactful outcomes.
  • Experience in solving highly complex and increasingly difficult problems, taking appropriate corrective action, and identifying and implementing improvements.
  • Competence with electronic data management systems, such as Medidata Rave (Rave Safety Gateway, ePRO, eConsent), Oracle Inform, Veeva EDC, etc.; MS Office programs, particularly Word, Excel, and PowerPoint; and data management vendor services.
  • Experience with clinical trial protocols and data collection documents, such as a CCG or DMP.
  • 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:

  • Knowledge of regulatory requirements for the conduct of clinical data management in global trials.

Alexionis 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. Furtherinformation about Alexion can be .

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 lackthereof, sex, sexualorientation, 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 aninteractive dialogue with Alexion regarding an accommodation, please contact . 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, clickhere.