Job Description

SUMMARY: To 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.

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

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.

Job Tags

Permanent employment,

Similar Jobs

Colony Tire Corporation

Warehouse Manager - Atlantic Tire Distributors Job at Colony Tire Corporation

...Summary:The primary and ultimate responsibility of the Distribution/Warehouse Manager is to oversee all facets of warehouse & distributing... ...:~Provide leadership and direction of the distribution center in support of Colony Tires policies & guidelines~Plan and direct...

FreshPoint a Sysco Company

Warehouse Shift Lead Job at FreshPoint a Sysco Company

...daily workload, sets priorities and directs team with meeting daily objectives while providing superior service to Companys Distribution Centers, Customers and Suppliers while maintaining a positive and proactive relationship with management and employees....

Black & Veatch Family of Companies

Lead Electrical Engineer - Solar Utility Scale Design (US Hybrid) Job at Black & Veatch Family of Companies

...role, you will have the opportunity to: Function as a technical lead design engineer managing, leading and designing a variety of solar utility scale projects and teams Develop electrical design deliverables of solar (PV) panels Create one line drawings and...

Windsor Care Center

Weekend Receptionist Job at Windsor Care Center

The Weekend Receptionist is responsible for greeting and assisting all visitors with outstanding customer service. Job duties include but are not limited to:* Answering calls and directing them to the correct unit, department or voicemail* Making sure all visitors...

WES Health System

Mental Health Worker Job at WES Health System

...GENERAL OVERVIEW OF KEY ROLES & RESPONSIBILITIES: The Mental Health Worker, meeting the requirements of a Case Manager, will provide intensive... ...their homes and community. ESSENTIAL & CORE FUNCTIONS: Assist the therapist in the provision ofindividual/family and/or...

Senior Clinical Data Manager Job at Worldwide Clinical Trials - USA, Durham, NC

VEl1cTRBajA5Q0VLZkFzYlJpWWJRVUIzanc9PQ==