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Job Details

Senior Specialist (Central Monitoring) MULTIPLE FTEs

Company: Docs Global (Continental Europe)
Location: Warsaw,Poland
Reference: Ref AS-025753
Closing Date: 18 Jul 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

DOCS is supporting highly prestigious and one of the world’s top pharmaceutical company that is bringing innovative ideas, products and services continuously improving people’s health. This is a fantastic opportunity for an experienced clinical research professional that is ready to take on a new challenge, further develop their career and enjoy working culture in vibrant Client's office in Warsaw.


Roles & Responsibilities of the position

Sr. Specialist, Central Monitoring, plans, validates and manages the central monitoring process in conformance to all relevant laws, regulations, guidelines, policies and procedures. Responsible for planning and executing the central monitoring aspect of clinical trials being conducted under analytical risk based monitoring (ARBM). This position proactively supports the Manager, Central Monitoring with central monitoring of clinical trials identified in this pilot stage. The focus of this position is to assist with the development and implementation of the ARBM activities initially for pilots, and expanding the role to further support all studies.

The range of tasks will include activities such as:
•Providing input into the integrated ARBM plan,
•Leading the cross-functional Central Monitoring Working Group (CMWG) for Analytical Risk Based Monitoring studies;
•Monitoring guidelines and source data verification plan,
•Ensuring historical site performance is gathered,
•Performing trend analysis,
•Maintaining oversight on site risk parameters and ensuring appropriate actions are taken to investigate the potential risks,
•Monitor operational risk parameters at a trial level, spot checks of monitoring visit reports,

Additionally to:
•Manage the day-to-day activities of the central monitoring of clinical trials in accordance with the standard operating procedures and good clinical practices;
•Create and maintains liaisons with internal clinical trials administration and operations department and with external contract research organizations to ensure high quality of data in clinical studies through adequate management of risk signals and implementation of mitigation plans;
•Ensure central monitoring of studies through interpretation of risk indicators and other trends, documents implications and provides status reports and identifies actions, follows up on completion of actions;

Job Requirements

•Good understanding of clinical research operations including on-site monitoring and site management is preferred ( at least 3 years of relevant work is required)
•Min. of 3 or more years of Clinical trials experience required (i.e. clinical operations, data management, biostatistics, or other relevant clinical development experience)
•Ability to operate and proactively use various systems and databases (CTMS, Rave, QRM Dashboard, Spotfire, etc.)
•Ability to identify risk and trends required. Data analysis and technical skills in the area of clinical trials/clinical data is required.
•Advanced communication skills

Remuneration & other details

•A challenging role in global Pharmaceutical company.
•Permanent office based position in a stable organization.
•You will enjoy highly competitive compensation and an exceptional benefits package

To apply:
For an immediate consideration please contact Dagmara Drozdowska on: +48 668 87 02 61or email your CV (WORD file) to:

Apply for this job: Senior Specialist (Central Monitoring) MULTIPLE FTEs

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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