Job Title: Clinical Data Manager

Therapeutic Experience: must have experience working on clinical studies, preferably within Oncology/CNS/Rare Disease

Full Time & Remote in the United States or Canada

Who we are

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

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 Global Data Management does at Worldwide

Data Management is an ever growing and collaborative department. Our global team is a group of diverse individuals with wide-ranging experience within the industry. From start to finish, we are involved in clinical studies beginning with building the study database, to locking and delivering the final dataset for the project. Data Management reviews and ensures the clinical study data is of high quality for regulatory submissions.

The Data Management group is the perfect place to launch or further your career. Whether it is technical expertise, or coming from a clinical background, you’re able to hone and expand your skillset within our department. Spanning various roles from data support staff, database and SAS programmers, coders and functional leads, there is place for you!

What you will do

• To manage each of the data management projects to which assigned; provide leadership to the corresponding data management teams and to represent Worldwide in all dealings with Sponsors with respect to the Data Management aspects of the projects to which assigned.
• To write specifications for the set-up and modification of database and edit check specifications for assigned projects. Create and review project specific documentation for assigned trials, i.e. the Data Management Plan and the Data Management File and create and review CRF and eCRF completion guidelines, EDC system manuals and access instructions.
• To produce information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendor.
To participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings. Ensure that any recommendations are discussed and that solutions are incorporated.

What you will bring to the role

• The job holder must be computer literate and numerate with a willingness to adapt to various computer systems.
• It is essential that the job holder works with close attention to detail and is questioning about the validity of the data being entered and has an ability to phrase data queries in an understandable and impartial manner.
• To have the ability to train new staff and to monitor their performance.
• Proven project delivery skills.
• Several years experience within Data Management or associated field.

Your experience

• Educated to degree level or equivalent
• 4-5 years clinical data management experience within a Clinical Research Organization (CRO) preferred
• Oncology experience preferred but not required

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

#LI-CS1 #LI-Remote