Alexion Pharmaceuticals, Inc. · 3 hours ago
Senior Clinical Research Associate (Central Midwest)
Wilmington, DE
Full-time
Onsite
Mid, Senior Level
4+ years expAlexion Pharmaceuticals, Inc. is seeking a Senior Clinical Research Associate (Sr. CRA) to oversee the delivery of studies at allocated sites. The Sr. CRA will collaborate with various teams to ensure compliance and proper study conduct, while also being the main contact with study sites.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP)
Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalate them as appropriate
Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles
Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plans
Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)
Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs
Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements. Supporting/participating in regular QC checks of the eTMF
In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study
Contributing to the nomination and selection of potential investigators and assisting with feasibility activities
Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders, as needed
Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to PMCO, Director COM, HCO and/or Quality Group as required
Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with PMCO, Director COM, and Quality Group
Qualification
Required
Minimum of 4 years of CRA monitoring experience
Bachelors degree in related discipline, preferably in life science, or equivalent qualification
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Excellent knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas
Good understanding of the drug development process
Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management
Excellent attention to detail
Excellent written and verbal communication skills
Excellent collaboration and interpersonal skills
Good negotiation skills
Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)
Valid driving license
Preferred
Ability to work in an environment of remote collaborators and in a matrix reporting structure
Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
Proactivity and assertive when communicating with internal stakeholders and sites
Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
Experience in all study phases and in rare medical conditions preferred
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
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2026-01-17
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2025-12-20
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