Senior Data Manager / Team Leader - 12 month contract, Basel

Key People

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Job ID :

9779


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

data manager, data management, manager, line manage, switzerland, clinical trials, CDM, SDM, contrac


Salary :

€90 - €96 per hour


Date Posted :

12 Dec, 2017



Company Name :

Key People


Location1 :

Basel




Job Category :

Data Management Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for an experience Data Manager with line management experience to join a leading Pharmaceutical company based in Basel, Switzerland on a 12 month contract basis - EXCELLENT HOURLY RATE - 105CHF. The ideal person will be available to start work as soon as possible and have a strong background in clinical data management.

REQUIRED QUALIFICATIONS AND EXPERIENCE

- Recognized degree in life sciences, mathematics, statistics. informatics or related disciplines
- At least 3 years experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical
- Data Management with good level of functional expertise in Data Management
- Good knowledge of international clinical research regulations and requirements (e.g., International
- Conference on Harmonization - Good Clinical Practice (ICHIGCP))
- Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report
- Form (CRF) design
- Ability to lead and coordinate the activity of DATA SCIENTIST(S) allocated to his/her study
- Good organizational and presentation skills Fluent in written and spoken English

RESPONSIBILITIES AND TASKS

- Ensures Clinical Development Data Management (CDDM) activities related to assigned study adhere to company Standards, applicable regulations
- Meets study timelines in terms of CDDM deliverables
- Ensures data handling consistency within allocated study(ies)
- Leads CDDM activities for assigned study
- Provides CDDM input to the development of the study protocol
- Coordinates the development of the (e)CRF in line with company standards
- Writes all study Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to DATA MANAGEMENT PROGRAMMERS for development for the allocated study(ies)
- Organizes, monitors and tracks the testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environment
- Organizes, monitors and tracks data cleaning, data review, query management, and database lock; makes sure processes are driven in collaboration with key Global Clinical Development (GCD) stakeholders
- Generates study metrics and status reports
- Represents CDDM at Clinical Trial Team (CTT) meetings
- Manages and is accountable for CDDM activities in studies where CDDM is outsourced
- Prepares and archives CDDM study documentation
- Presents study related topics at CTT, Investigators and Monitors meetings
- Participates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for CDDM
- Represents CDDM in cross functional working groups related to the system I process
- Forecasts study team resource requirements
- Ensures Data Scientists assigned to study have required training
- Ensures Study Data Tabulation Model (SDTM) deliverables (Including SDTM datasets, define.xml and annotated CRF) are created, validated and provided as per agreed timelines

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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