19 feb
Sin nombre
Cajamarca
Accountability and Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch:
point. In short, to be the partner of choice in drug development. Thats our vision. Were driven by it. And we need talented people who share it. If youre as driven as we are, join us. Youll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and youll be helping shape an industry. If you have an extensive experience interpreting clinical trial protocols for the purpose of establishing and designing the documentation requirements within Trial Master File system,
learn more about how you can be a part of ICONs Trial Master File Operations group thats responsible for verifying clinical trial documentation is consistent with the TMF specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.**About the Senior Trial Master File Lead role within ICON:
** The Senior Trial Master File Lead will play a lead role in ensuring the Trial Master File project specifications are in alignment with program strategies and milestones.* Assess the impact of potential changes to TMF specifications prior to implementation and collaborate with Sponsor Teamsas appropriate. Serve as the single point of contact for functional team members and clients related to TMF processes and activities.* Under the supervision of the TMF Operations Leadership team, the Trial Master File Owner/Lead will assist with responses to regulatory authorities/inspectors with regard to documentation management activities for audits, questions, and issues.* The Trial Master File Lead will regularly review metrics established for performance,
review data quality outputs and audit outputs to identify trends per study and across programs, and assist with the development of corrective action plans related to TMF findings.* The Senior Trial Master File Lead will review the processes to actively identify continuous improvement opportunities and enhance operational efficiency. Working in a professional and employee friendly environment, the Senior TMF Lead will play a lead role in communicating within both internal and external clients in a professional manner.**To succeed you will need:
** Bachelors Degree is required along with a minimum of 7+ years of Clinical Operations/Documentation Management/Clinical Research industry experience.* You will require TMF and industry experience to understand the processes and documents required within the conduct of clinical trials.
- You will have good organizational and negotiation skills, the ability to manage multiple tasks and proven experience of high standards of attention to detail.
- You will possess good written and verbal communication skills with global projects/team exposure. Project Management and Quality Assurance experience will be an added advantage* Competent computer skills:
MS Outlook, PPT, Excel and experience with electronic document management systems preferred.**Benefits of Working in ICON:
**Our success depends on the quality of our people. Thats why weve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuse
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