Ref #: 28439

Employment type: Fixed term - Full-Time

Location: Germany - Home Based

Posted: 16-Apr-2021

Description

For a multinational biopharmaceutical company DOCS is hiring a Senior Clinical Trial Coordinator (m/f/d).

An exciting opportunity has arisen to join our healthcare business to support the development of first and best in class specialty medicines for our patients in need as Contractor. You will work in a new established group, that provides a shared service center support for study teams of Phase I - Phase IV (interventional & non-interventional) and Investigator Sponsored Studies with and without CRO involvement. As a Clinical Trial Coordinator, you will manage activities within a dedicated Center of Excellence for operational deliverables of Clinical Studies with interactions of multiple cross functional Biopharma functions and CROs.


Role and Responsibilities:

• Conduct Trial Master File Oversight and Archiving Management
• Perform Operational data entry & oversight in systems
• Request and coordinate Study Insurance
• Support Contract Management for Investigator sponsored studies as well as Corporate sponsored studies, legal department interactions, Confidential Disclosure Agreements
• Support Inspection Preparation & Inspection Readiness related activities
• Conduct CAPA and SUSAR tracking
• Provide regional Dashboards, Data Driven Oversight (DDO) reports & site individual packages
• Responsible for study key deliverables tracking
• Perform Safety listings tracking and Safety Check Desk tasks



What is required :

• Graduate background (e.g. Bachelor’s degree) in scientific field plus at least 2 years of professional experience in Biopharma or CROs.
• Non-graduate jobholders require a substantial amount of professional experience (minimum of 4 years) in Biopharma or CROs and additional qualifications that also provide exposure to fundamental clinical research related skills & knowledge
• Good oral and written communication in English
• Familiar with Trial Master File Handling, including use of eTMF System
• Experience to use the DIA TMF Reference Model as TMF Filing Index
• Familiar with use of CTMS System
• Ability to work in an international/ multicultural cross functional matrix environment
• Good understanding of the policies and procedures of Clinical Operations and of ICH-GCP
• Good administrative, coordination and problem- solving skills
• Good time and priority management, ability to work efficiently under pressure
• Strong computer skills including knowledge of MS Office™ (Excel™, Word™, PowerPoint™), Outlook and TEAMS


Why this vacancy is right for you:

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

At DOCS , our people are our greatest asset.

Our primary focus is on the acquisition, management and development of the best candidates in the drug development industry so that they can continue to drive the success of the business and meet the individual needs of our customers.

The DOCS leadership is comprised of key influencers and industry experts, bringing years of experience to the company.

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that have a direct impact on the health and quality of life of the patients.

Interested?

Please submit your CV to roger.bravomendez@docsglobal.com or call me on
+49 (0) 175 268 7114.

We are looking forward to receiving your application.