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Clinical System Data and Reporting Analyst (2 year Maximum Duration co

Eingestellt von Celgene

Gesuchte Skills: Support

Projektbeschreibung

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

1. Coordinate administration activities for Celgene systems and processes including

a) Perform data analysis and run quality control checks within Clinical System to ensure compliance to data capture procedures; interface with functional areas on quality issues through to resolution
b) Verify training completion and grant clinical system access requests; manage creation and close out of user accounts in accordance with employee function, role and employment
c) Ensures consistency and accuracy of information and reporting through periodic checks and identifies issues; resolves issues though data collection and reporting improvements, eg Generation of compliance report for CelAlert (Acknowledgementensure validity of data across multiple stand alone systems
j) Deliver training presentations as needed

Reporting support to Central Services activities:

a) Facilitate the collection and documentation of reporting requirements for existing/new users
b) Coordinate and/or execute on data extraction request from functional areas or individual requestors
c) Create or generate action driven reports or custom extracts using relevant data
d) Work in conjunction with Clinical System Administrator to generate additional reports and other supplemental tools; develop and deliver training on use of standard reports

2. Provide project support to Central Services activities including:

a) Perform or support file review of safety event filing in the TMF compound file
b) Distribute SAEs to the Study Teams
c) Maintenance of the ECSRS - Ethics Committee Safety Reporting System containing EC contact information and oversee process around ECs in EU and ROW
d) Quality control of the monthly ICSR Notification report, EU

*LI-NS1
*MONEU

QUALIFICATIONS

3. Skills/Knowledge Requirement:

a) Familiarity with systems and processes related to Clinical Trial Management.
b) Prior experience in a clinical research and development operations role (eg CRA or CTA/CSA)
c) Previous experience with entry and data management within clinical systems (eg Document Management Systems, CTMS, EDC, IVRS, Investigator Portals)
d) Solid understanding of global management of clinical studies and the clinical drug development process, regulations and guidelines
e) Ability to multitask projects from multiple assignments
f) Demonstrated ability to diagnose and resolve issues proactively with minimal supervision in a fast paced environment
g) Familiarity with System Development Life Cycle Methodology
h) Computer literate; familiarity with Microsoft Office programs including Microsoft Project, commonly used technologies for clinical trials, and reporting/analytic software
i) Attention to detail
j) Strong communication skills and ability to interact across multiple functional areas, including IT; ability to present and explain technical information in a simplified manner to support user community training and overall compliance

REQ ID:
PRIMARY LOCATION: Switzerland--MARIN
JOB:Research and Development
ORGANIZATION:Celgene R&D Sarl
SCHEDULE:Limited Term
SHIFT:Standard
EMPLOYEE STATUS:Individual Contributor
JOB TYPE:Full-time
JOB LEVEL:Day Job
TRAVEL:No

Projektdetails

  • Einsatzort:

    Marin-Epagnier, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Celgene