Senior Clinical Data Manager
Worldwide Clinical TrialsAbout the role
Who we are
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 Senior Clinical Data Manager does at Worldwide
Oversee, lead, manage and provide technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate and timely manner to the Sponsor’s satisfaction.
What you will do
Provide fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex global projects/programs, including:
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).
Ensure effective UAT is performed.
Write external vendor reconciliation specifications for programming reconciliation outputs (e.g. Serious Adverse Events, IRT, Central Laboratory).
Oversee data cleaning activities.
Produce metrics to monitor the progress of trial activities.
Ensure all database lock activities are completed on time.
Represent Worldwide DM at both internal and external study meeting calls, including providing input.
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.
Provide feedback on process improvements to DM Management and/or SMEs.
Participate in and lead process reviews.
Provide training, support and mentorship to other members of the DM department.
Participate as necessary in sponsor audits, regulatory authority inspections and other third-party meetings.
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