Senior Clinical Research Associate
Location: Field (UK)
Are you passionate about making a positive and impactful difference to the lives of others through Clinical Research? Join Alexion as a Senior Clinical Research Associate.
About Alexion, AstraZeneca Rare Disease
At Alexion, we’re dedicated to delivering life-changing medicines for those with rare and devastating diseases. Our patient first approach informs all our decision-making, and we invest in team and individual development. Ours is an energetic, fast-paced way of working that is solutions focused and collaborative.
About the role
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 UK country team. The Sr.CRA works in close collaboration with other CRAs and the UK Country Operations Management (COM) Team to ensure that study commitments are achieved in a timely and efficient manner. The Sr.CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery and compliance of the study.
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 and that the sites deliver according to their respective commitment in the individual studies.
Requirements:
Minimum of 4 years of CRA monitoring experience
Bachelors degree in related field, 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 details.
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
Desirables:
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 make valuable contributions 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 handle multiple tasks with conflicting deadlines.
Proactivity and assertivity when communicating with internal collaborators 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.
Why Alexion?
Joining Alexion, AstraZeneca, Rare Disease means embracing an opportunity where work isn’t ordinary, in a company where 'Here it means more' is more than a statement, it’s an ethos. We are a beacon in the global BioPharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare.
Competitive salary and benefits package on offer.
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.