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Job Details

GCT-SU Specialist Service

Company: Docs Global (Continental Europe)
Location: Braine L'Alleud,Belgium
Reference: Ref AS-023477
Closing Date: 25 Mar 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

As Global Clinical Trial Submission Specialist you are planning, coordination, preparation and tracking of the documents needed for initial submission Start-up) and Substantial amendments (ongoing) of Clinical Study package for all countries (except US) in compliance with the Country Regulatory Requirements, EU clinical Trial directive, related Guidance, and client's processes.


Roles & Responsibilities of the position

Key Responsibilities and Major Duties

? Support the GCT-SU Specialist in optimally preparing and distributing Substantial amendments and initial CTAs to country applicants for submission to Competent Authorities and Ethics Committees.

1. Apply for EUDRACT and UTN number and for studies with EU participation and ensure appropriate communication of the obtained number to the Protocol Managers.

2. Assist GCT-SU Specialists with the preparation, distribution and tracking of the Clinical Trial Application dossier and subsequent amendments.

3. Index NODs, POAs, EudraCT into eTMF.

4. Maintenance of GCT-SU trackers and IRIS (HA submission and approval Tracking system) creating entries in the system for initial and Substantial amendment and entering the content of the core documentation. Supports team in researching inquiries, tracking, interpreting data for completeness/quality and follow-up with the required stakeholders.

5. Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, maintain departmental SharePoint

6. Support GCT-SU in creation of End of Trial and tracking, as well as distribution of CSRs to Country Applicants.

7. Contributes to other requirements as appropriate to allow proper functioning of the GCT-SU.

? Support implementation of the EU CT REG Portal.

? Contribute to the Country Requirements Repository by collecting and sharing additional country requirements.

? Ensure timely support for Investigator Sponsor Research Trials (ISRs) at EU level. Create cross Reference Letters and when not possible coordinate submission of CMC documentation with local Regulatory.

? Contact point for the coordination of Special Documents for CTA submission, such as NOD, PoA, LoA.

Job Requirements

? Fluent in English (written and spoken)

? Demonstrates a general understanding of the clinical research process.

? Proficient use of other applications and software (Excel, Powerpoint, eConferencing, etc) to fully support processes.

? Demonstrates flexibility to work simultaneously on projects of different therapeutic areas and different countries. Communicates effectively using excellent verbal and written skills with both internal and external key stakeholders; coordinates information and document flow to and from both internal and external customers.

? Works well in a team environment, collaborates effectively with internal groups and demonstrates a “can do” approach. Utilizes effective problem-solving approaches and independently follow-up and resolves outstanding issues, within deadlines to achieve key deliverables.

? Exhibits flexibility and willingness to develop new skills by being receptive to new systems and processes. Seeks to identify and implement best practices.

? Analytical and detailed-orientated skills in tracking and analyzing numerical and other data

Remuneration & other details

For more information please contact:
Iris Brouwer +31 (0)6 51129787

Apply for this job: GCT-SU Specialist Service

Contact Information:

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

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