Clinical Database Designer
Employer: Worldwide Clinical Trials
Location: UK/Europe - Remote
Working hours: Full time
Salary: Not listed
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We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Data Management Department does at Worldwide
Our Data Management team is an ever-growing and collaborative group of diverse individuals with wide-ranging experience within the industry. From start to finish, we are involved in clinical studies – from crafting the study database to ensuring the pristine delivery of the final dataset. We meticulously ensure data accuracy and integrity, crucial for groundbreaking regulatory submissions. With a variety of roles, from data support staff, database and SAS programmers, coders, and functional leads, there are many opportunities to launch and further your career. Our team embraces an environment that invites input, fosters personal growth, and empowers your professional journey.
What you will do
Provide support in planning, directing, and managing the clinical database design and maintenance process.
Work closely with the Lead Data Manager in the development of the clinical database design timeline. Review the protocol and associated study reference materials for assigned studies to determine the specific database design requirements.
Design and review electronic case report forms (eCRFs) and support the set up of electronic data capture (EDC) systems for assigned projects in adherence with protocol requirements.
Author and review the Edit Check Specifications for assigned projects.
Work closely with the Lead Data Manager and Clinical Database Programmer to ensure accurate implementation of database design and edit check requirements.
Lead sponsor meetings to review draft eCRFs and ensure all sponsor requirements are addressed.
What you will bring to the role
Ability to communicate effectively, orally and in writing, with personnel on all professional and administrative levels.
Proven leadership and interpersonal skills in complex team situations.
Excellent presentation skills and the ability to build relationships with both internal and external clients.
Good time management skills and the ability to manage multiple deadlines whilst maintaining the highest standards of quality
Your experience
Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience.
Three to five years' experience in protocol interpretation and designing clinical databases, including Medidata Rave and/or Merative Zelta.
Familiarity with CDISC and CDASH standards.
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