Senior Clinical Data Manager (Remote/UK)

Employer
Worldwide Clinical Trials
Location
HOMEWORKING, Nottingham, GB
Salary
Competitive
Closing date
23 Sep 2020

View more

Discipline
Data Management / Statistics, Clinical Data Management
Hours
Full Time
Contract Type
Permanent
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Worldwide Clinical Trials is hiring a Senior Clinical Data Manager to join our growing team!

The Senior Clinical Data Manager will provide leadership, management and technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate and timely manner to the Sponsor's satisfaction.

RESPONSIBILITIES:
Tasks may include but are not limited to:
  • To manage each of the data management projects to which assigned; provide leadership to the corresponding data management teams.
  • To represent WCT in all dealings with Sponsors with respect to the Data Management aspects of the projects to which assigned.
  • To liaise with the Director, Data Management at regular intervals to discuss progress and any issues outstanding.
  • To take responsibility for staff training for all projects to which assigned; both direct involvement in training and supervision of staff assigned to training.
  • To liaise and collaborate with corresponding teams in other WCT departments working on the same project.
  • To ensure that all data management operations are conducted to WCT SOPs; contribute to the ongoing revision/improvement of these SOPs.
  • To create and review project specific documentation for assigned trials, i.e. the Data Management Plan and the Data Management File.
  • To write specifications for the set-up and modification of database and edit check specifications for assigned projects.
  • To write and validate Manual and SAS checks.
  • To set-up processes for reconciliation and perform reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory).
  • To perform verification and User Acceptance Testing of configured databases.
  • To support and oversee all data cleaning activities for assigned projects.
  • To specify and review SAS listings/SAS tables for assigned projects.
  • To create and review CRF and eCRF completion guidelines, EDC system manuals and access instructions.
  • To train others to make full and correct use of the company Data Capture systems, when used, for the collection of clinical data.
  • 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 liaise with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees (CEC) within clearly defined guidelines for matters concerning processing of data.
  • To ensure that adequate QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects.
  • To ensure timely database locks for all assigned projects.
  • 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.

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 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.

REQUIREMENTS:
  • Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience 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.

#LI-HD1

Are You Seeking A Career With Purpose?

The time is right to join our growing team, consisting of 1,600 talented and dedicated employees from across the globe. We’re doing innovative and exceptional work each and every day. Our team is filled with purpose, as we support our sponsors in the discovery of cures and treatments for diseases affecting millions of people around the world.

If you’re looking to join an energetic and collaborative team that is valued and supported by company leadership, committed to operational excellence and open to creativity and innovation, Worldwide Clinical Trials could be the ideal place for you. We have exciting opportunities in clinical drug development, project management, corporate functions, sales, and more. Explore current openings and learn more about Worldwide’s culture below.

What We Believe

At Worldwide we operate under a shared mission, vision and set of cultural values. But these aren’t just words on a page. They are a daily inspiration and a shared commitment. Because we know that when we work towards a common goal and when we bring our best selves to the job every day we can climb mountains for our customers!

Contact Us
  • 2nd Floor
  • 172 Tottenham Court Road
  • W1T 7NS
  • GB
  • 0207 121 61 61
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