Program Data Manager
Worldwide Clinical Trials - Morrisville, NC

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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.

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 necessary in sponsor audits, regulatory authority inspections and other third party meetings. Ensure than any recommendations are discussed and that solutions are incorporated.

Perform 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.

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 to be 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.

Excellent time management and man management skills

Proven project delivery skills

Several years experience within Data Management

Educated to Degree level

The company reserves the right to amend this job description in consultation with the employee to reflect changes in its organisational structure or to the job itself in line with emerging business needs.

Promotion 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.

Required Skills

Required Experience

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About Worldwide Clinical Trials Worldwide Clinical Trials is a global CRO providing full-service drug development services to the...