Program Clinical Data Manager - US - Remote
Multiple Locations: Raleigh, North Carolina, United States • United States
Requisition Number: 3899
Position Title: Program Clinical Data Manager
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 almost 2,500 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.
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!
The Program Clinical Data Manager will 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 client’s 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 incorporated
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.
- Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience
Employment Type: Regular
Community / Marketing Title: Program Clinical Data Manager - US - Remote
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Raleigh, North Carolina US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.