Program Clinical Data Manager - Worldwide Clinical Trials : Job Details

Program Clinical Data Manager

Worldwide Clinical Trials

Job Location : Durham,NC, USA

Posted on : 2024-11-24T06:26:36Z

Job Description :
Who we areWe'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 WorldwideWe 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!*SUMMARY: To manage the client relationship for an assigned key client, providing leadership, management and technical expertise to personnel working on trials from the assigned Key client, ensuring that these trials are executed in an efficient, accurate and timely manner to the client's satisfaction.**RESPONSIBILITIES:*_Tasks may include but are not limited to:_To manage the client relationship of the assigned key client.To represent WCT at meetings with the key client, and in all dealings with the clients staff with respect to Data Management.To liaise and collaborate with other WCT departments working with the same client.To manage the trials of the assigned client, providing leadership and management to the corresponding data management team.To take responsibility for the training, development and performance of assigned staff.To ensure that all data management operations are conducted to WCT SOPs; contributing to the ongoing revision/improvement of these SOPs.To coordinate the design of the paper or electronic Case Report Form as required.To write specifications for the set-up and modification of project specific data entry and consistency checking software for assigned trials.To set-up and review project specific documentation for assigned trials.To produce information/reports directly from the clinical database or via the appropriate procedure to request a new report from either the Statistics department or IT department as required.To co-ordinate those aspects of adverse event management and central event adjudication which relate to assigned projects and to write or approve the corresponding Manuals/guidelines. To represent WCT in dealings with Endpoint committees or their designates, as required.To train others to make full and correct use of the company Data Capture systems, when used, for the collection of clinical data.To ensure that adequate QC checks and Database Quality Assessments are performed on the clinical databases of assigned projects. To participate as required in sponsor audits, regulatory authority inspections and other third party meetings. Ensure than any recommendations are discussed and that solutions are incorporatedPerform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive*OTHER SKILLS AND ABILITIES: *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.The job holder must have the management and team leadership skills necessary to lead a data management team.To have the ability to train new staff and to monitor their performance.Proven project delivery skills.Excellent time management and man management skills.Several years experience within Data Management or associated field.*REQUIREMENTS:*Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experiencePromotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law
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