[Alexion] Sr. Clinical Research Associate

This is what you will do:

• The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The Sr. CRA works in close collaboration with Project Management Clinical Operations (PMCO), the Study Start-Up (SSU) Manager, Clinical Study Assistant (CSA) and other CRAs in Clinical Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner at the country level. The Sr. CRA acts as the main contact for the study site and is responsible for monitoring the study conduct to ensure proper delivery and compliance.

• The Sr. CRA is responsible for the selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations while ensuring that sites deliver according to their respective commitment in individual studies.

• A Sr. CRA with demonstrated skills and experience may take on additional responsibilities and tasks as needed, such as serving as a Lead CRA.

You will be responsible for:

• Performing selection, initiation, interim monitoring, and closeout visits, both remotely and on-site, 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 by proactively identifying study-related issues, ensuring their timely resolution, and escalating them as appropriate.
• Training, supporting, and advising investigators and site staff on study-related matters, including Risk-Based Quality Management (RBQM) principles.
• Developing recruitment plans with each site and managing and supporting enrolment to ensure that sites and studies meet enrolment milestones. Documenting recruitment barriers and mitigation plans.
• Ensuring that agreed monitoring KPIs are monitored and remain within the agreed acceptable quality ranges, including action-item ageing, data-entry metrics, query ageing, and MV report metrics.
• Preparing and finalising monitoring visit reports in the CTMS and providing timely feedback to the Principal Investigator, including the follow-up letter, within the required timelines and in line with Alexion SOPs.
• Ensuring the timely collection and uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs**,** and local requirements, and supporting or participating in regular QC checks of the eTMF.
• Supporting study start-up and regulatory maintenance, where required. Tasks may include the collection, preparation, review, and tracking of documents for the application process, as well as the submission of appropriate applications and documents to the EC/IRB and Regulatory Authorities for start-up and throughout the study.
• Contributing to the nomination and selection of potential investigators and assisting with feasibility activities**.**
• Collaborating with local Medical Affairs, the 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 SLCO, SML, PMCO, COML, HCO**,** and/or the Quality Group, as required.
• Preparing for and collaborating on activities associated with audits and regulatory inspections, in liaison with PMCO, SML, COML, and the Quality Group.

You will need to have:

• A minimum of 4 years of CRA monitoring experience.
• A bachelor's degree in related discipline, preferably in life sciences, or equivalent qualification.
• Excellent knowledge of international guidelines, including ICH-GCP, and basic knowledge of GMP/GDP.
• Excellent knowledge of relevant local regulations.
• Good medical knowledge and the ability to learn about relevant Alexion Therapeutic Areas.
• A Good understanding of the drug development process.
• An 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.

• Flexibility in scheduling and willingness to travel. (required travel may be as high as 70% during busy periods)

• A valid driving license where required by the local market.
• Solid knowledge of clinical development processes with strong emphasis on monitoring.

We would prefer for you to have:

• The ability to work in an environment with remote collaborators and within a matrix reporting structure.
• The ability to manage change with a positive approach for yourself, the team, and the business**, and to see** change as an opportunity to improve performance and add value to the business.
• The ability to identify and champion more efficient and effective methods and processes for delivering quality clinical trials with a reduced budget and in less time.
• The ability to prioritise and manage multiple tasks with conflicting deadlines.
• Proactivity and assertiveness when communicating with internal stakeholders and sites.
• The ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems and software in an e-enabled environment.
• A team-oriented and flexible approach, with the ability to respond quickly to shifting demands and opportunities.
• Experience in all study phases and in rare medical conditions is preferred.
  

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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.