Company: Docs Global (Continental Europe)
Reference: Ref AS-019374
Closing Date: 10 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Your Development Plan will challenge you to further develop your personal skills and competencies, to build your career within our global organization. Other than working with a great team of smart and energetic people, we also offer competitive salary and benefits package.
Roles & Responsibilities of the position
Distributes feasibility questionnaires to investigators being considered for study participation, tracks and summarizes results.
Checks investigator against FDA OAI and debarment list.
Distributes final documents (investigator list, IB, protocol, ICF template, FDF) to sites.
Initiates and tracks confidentiality agreements with sites.
Initiates and maintains investigator and site contact information.
Initiates sites in CTMS.
Updates and ensures accuracy of sites in CTMS as appropriate.
Maintains and updates CTSRS contact information to ensure appropriate SUA distribution when necessary.
Reviews documents received from sites for accuracy and completeness. Ensures that they comply with SOP’s and regulations. Confers with LTM /GTM regarding changes as appropriate.
Reviews Informed Consent modified by investigator site in conjunction with LTM. Secures approval of changes.
Works with sites to ensure that necessary corrections are made to expedite the document collection process.
Tracks status of documents to reflect receipt and approval.
Notifies LTM/GTM of site status and approval status so that drug can be shipped. Partners with RSM for scheduling of study initiation visit.
Assembles Trial Center File Binder and study start-up materials with input from LTM.
Maintains Trial Master File (IF) either paper or eTMF.
Establishes and maintains good working relationships with the site investigational staff.
Coordinates central IRB submissions. Processes, tracks, and distributes documents as required for protocol amendments.
Tracks SUA receipt acknowledgment letters from investigators.
Experience: 0-2 years pharmaceutical industry experience, 3-5 years experience in related field without degree
High school diploma or BA/BS in a scientific discipline
Relevant CTA working experience in CRO or Pharma company and relevant experience in use of Medidata systems, M-CTMS, Vault-TMF, Rave, and Siebel
1. Excellent written and oral communication skills.
2. Knowledge of Microsoft Office applications especially Excel.
3. Good interpersonal skills demonstrated as energetic, proactive, enthusiastic, and independent thinker.
4. Ability to negotiate and obtain commitment and buy-in from customers, suppliers and team members.
5. Ability to collaborate and build strong partnership/relationships with all functions involved in the trial
6. Excellent organizational skills.
7. Ability to handle multiple priorities within matrix environment.
8. Works and meets deadlines with some supervision.
9. Under guidance of LTM/Line Management take appropriate actions within framework of established SOPs.
Additional Information: Individual must exhibit scientific knowledge, flexibility and strong interpersonal skills. Good problem solving skills are desirable as well as ability to make suggestions to improve efficiencies.
Company offers you a professional, international, dynamical and high quality working environment, where personal development is stimulated and personal initiatives are encouraged.
If you are interested in please send you CV to this email address.
You can find my contact details:
M 00 36 70 383 1286
F 00 36 1 778 9223
T 00 36 1 430 4348
2 Globeside, Globeside Business Park
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