Senior Clinical Data Lead (Cdl)

Astrazeneca

2+ years

Not Disclosed

Remote

10 Oct. 22, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Data Lead (CDL)
Location: Alexion Canada

About Alexion: Transforming Lives through Innovative Medicines

Since our operations began in Canada in 2009, Alexion has been dedicated to bringing innovative therapies to millions living with rare diseases. With a pioneering 30-year legacy, our commitment to patient-centric decision-making drives our mission to transform lives.

What You Will Do

As a Senior Clinical Data Lead within our Clinical Data Management (CDM) division, you will independently ensure the accuracy and timely delivery of clinical data for both study and non-study projects. Your contributions will extend to developing new concepts, technologies, and standards, performing tasks essential for the accuracy, completeness, and compliance of data crucial for publications and regulatory submissions.

Responsibilities

Collaboration: Work with peers across the data management function to design and deliver effective data management solutions.
Oversight: Manage project deliverables from Contract Research Organizations (CROs), Functional Service Providers (FSPs), and vendors, ensuring tasks are completed promptly.
Innovation: Develop new data collection methods to support the timely delivery of medicines to patients, leveraging critical thinking and collaboration.
Study Start-Up: Lead study-specific tasks, including case report form (CRF) design, edit check creation, user acceptance testing, and maintenance of the Data Management Plan.
Data Validation: Participate in data validation tasks during study maintenance and close-out, focusing on data integrity and quality metrics.
Operational Support: Provide ongoing operational support during clinical trials, including database migrations, ad-hoc report creation, and support for database lock and archiving activities.
Medical Coding: Ensure that medical coding is completed for all data cuts and is reviewed and approved by medical monitors.
User Administration: Oversee user administration in data management systems and ensure timely filing of Trial Master File documents.

Qualifications

You Will Need:

A bachelor’s degree in a scientific field or equivalent.
Proven experience in clinical data management for 3 to 4+ years, or equivalent experience in a hospital or research site, with a strong understanding of medical terminology.
Knowledge of clinical data management processes, regulatory submissions (FDA, EU), and CDASH principles.
Familiarity with MedDRA/WHO-DD dictionary coding and digital/data visualization technologies.
Strong written and verbal communication skills for effective interaction with diverse personnel.
Excellent organizational skills to manage multiple projects and responsibilities effectively.
Experience in solving complex problems and implementing improvements.
Proficiency with electronic data management systems (e.g., Medidata Rave, Oracle Inform) and MS Office programs.

We Would Prefer:

Knowledge of regulatory requirements for global clinical data management trials.
Experience overseeing start-up, conduct, and close-out activities for multiple or complex studies.
Familiarity with CDISC data standards.
Experience with data analytics and visualization tools.

Our Canadian Team

With over 200 employees, our Canadian team includes a global research and development hub and dedicated local professionals. Together, we are driving patient impact locally and globally.

How We Work

At Alexion, we foster bold thinking by bringing unexpected teams together. Our in-person working model, averaging three days per week in the office, encourages connection and collaboration while respecting individual flexibility.

Join Us

Alexion is committed to diversity and equality of opportunity, building an inclusive team that reflects a wide range of perspectives. We welcome applications from all qualified candidates and comply with all laws regarding non-discrimination in employment. Accommodation for persons with disabilities is available upon request during the recruitment process.

Become part of our mission to transform lives—apply today!

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