Regional Clinical Trial Asistant

Employer
Docs Global (Continental Europe)
Location
Warsaw, Poland
Salary
Competitive
Closing date
24 Sep 2020

View more

Discipline
Clinical Research, Clinical Trials Manager / Administrator
Hours
Full Time
Contract Type
Permanent
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CTA performs administrative tasks to support the CDC trial teams (Trial Managers and Clinical Research Associates) for assigned clinical trials in accordance with the Sponsor's policies and procedures, SOP's, local legislation and GCP requirements. The position is based in Warsaw, Poland and reports to CTA Team Manager, CDC Poland.

Essential responsibilities
•Oversight of all trial documentation for assigned clinical trial, covering all involved adjacent affiliates within the CDC:
- CTA documentation to support affiliates in HA and EC submissions,
- Ensure overview of local requirements.
•Oversight of the documents filed into the eTMF: technical quality review and quality control of documents. Timely eTMF handling and archiving.
•Timely updating of relevant trial logs in the system.
•Timely completeness check of trial documentation in the system.
•Ensure timely and adequate archiving at closeout.
•Providing Investigator Trial Master Files (ITMFs) core input and additional patient material during a course of study.
•Supporting in bulk document distribution to sites.
•Updating data in CTMS (RDA role).
•Supporting clinical supplies management and tracking all relevant processes.
•Other administrative tasks as relevant (incl. payments, management of mailing lists, generic mailboxes, support in organisation of local meetings and department meetings).

Qualifications
•Preferably Master/Bachelor degree in life sciences
•Very good English - written and spoken
•At least one year on the similar position
•Excellent organization and long-term planning skills
•Ability to work independently in a structured and pro-active manner as well as part of the different trial teams
•Ability to manage multiple priorities
•Keeping focus on details and at the same time maintain overview and quality
•Cross-cultural awareness and ability to cooperate in multi-national environment
•Very good communication skills - ability to communicate and build relationships with various stakeholders
•IT proficiency (including MS Office: Outlook, Excel, Word, PowerPoint)
•Knowledge of eTMF systems, such as Veeva Vault is considered an advantage

DOCS provides 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. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business Park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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