Senior Clinical Data Manager - UK/Europe - Remote

Worldwide Clinical Trials • Durham, NC

2d • Remote

About The Position

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.

Requirements

• Excellent attention to detail with outstanding written and verbal communication skills.
• Strong knowledge of data management best practices & technologies as applied to clinical trials.
• Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams.
• Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Strong analytical and problem solving skills.
• Independent and autonomous project oversight skills.
• Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience
• Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.

Responsibilities

• Provide fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex global projects/programs
• Ensure appropriate resources are allocated to complete all DM activities on time and budget.
• Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs).
• Write external vendor reconciliation specifications for programming reconciliation outputs (e.g. Serious Adverse Events, IRT, Central Laboratory).
• Monitor project scope, budgets and risks and alert DM Management of any concerns.
• Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g. during Project Review Meetings).
• Collaborate with internal Worldwide departments working on the same project.
• Participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level