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Clinical Trial Coordinator, 10 month contract

Job Title: Clinical Trial Coordinator, 10 month contract
Contract Type: Contract
Location: Darmstadt, Hessen
Industry:
Salary: competitive daily rate
Start Date: ASAP
Reference: 71781-PHARM-VLB_1530186943
Contact Name: Vladyslav Babych
Contact Email: Vladyslav.Babych@volt.eu.com
Job Published: June 28, 2018 12:55

Job Description

In this role you will be responsible for:
* Overseeing external providers (CRO)
* Managing relationship with key external stakeholders (investigators)
* Building and managing site relationships while overseeing site-level study start-up, conduct, and close-out activities outsourced to a CRO for global programs across different Therapeutic Areas
* Act as liaison between the company and investigational sites building investigator and site staff in relation to any clinical trials related matters
* Contribute development of and implement a plan in collaboration with the global and local organization to raise the profile of the company and its global clinical development projects with current and potential investigators
* Ensures ICH/GCP/local regulatory requirements are observed
* Proactively work with Medical/Patient Associations to build company network and to promote company clinical trials
* To develop the knowledge of site capabilities and past performance
* To ensure regular communication with local organizations to align interactions with KTLs and other relevant local/regional stakeholders
* Managing and steering CROs
* Establish effective communication and work with - Site Management Leads - channelling information on trials for respective programs - Clinical Trial Management (esp. Clinical Trial Lead) - Medical Site Liaison of country or region of operation


Minimum Requirements:
* Secondary education with commercial, lifescience or secretarial diploma(s) or higher degree.
* (Science degree or biomedical degree an asset)
* Understanding of local / country requirements for clinical trials
* Min 3 year experience in Project Management or Coordination role in CRO, Pharmaceutical or Biotechnology Industry
* Proven experience in all aspects of clinical trial coordination
* Expertise in TMF management (eTMF & paper) and oversight.
* Excellent understanding of the policies and procedures of Clinical Operations and of ICH-GCP
* Very good oral and written communication skills in English as well as excellent administrative and budgetary skills