Closing Date: 02 Jan 17
Type: Full Time
Salary (£): Competitive
This position is located in one of our US offices: Cary or Wilmington, NC; King of Prussia, PA; Bristol, TN.
Job Description Office locations – Cary or Wilmington, NC; King of Prussia, PA; Bristol, TN.
Expert in regulatory, project startup and/or related maintenance activities for a particular country or region. Responsible for leading or executing the majority of regulatory, startup and/or maintenance activities on projects, within the project timelines and in line with the RSS budget.
Specific responsibilities for a particular individual, project or region may be adaptable to accommodate individual experience and interest, department needs, and regional requirements across the RSS spectrum to include leading and performing regulatory and ethics submissions, participating in study feasibility to support conduct of a trial, and collecting or approving essential documents.
The Senior RSS Specialist leads RSS projects including, project oversight of other RSS team members.
Accountabilities / Responsibilities
1. Where delegated, to act as a Critical Document reviewer & approver.
2. Act as a lead on designated studies depending on experience and resource requirements.
3. Provide support to other team members within the local office and act as a mentor to other RSS professionals.
4. Take responsibility for the development of local tools and guidance documents to ensure an effective and efficient start-up including but not limited to country start-up summaries, template letters, tracking of local requirements etc.
5. Provide functional leadership to the team members working one or more projects. Ensure satisfactory performance and completion of the project during the start-up phase and for specific tasks at other time-points in the study.
6. Ensure that project team members are aware of their requirements according to the agreed budget. Inform the Project Manager if there is a requirement to deviate from agreed budget, timelines or resource or potential out of scope activities.
7. Act as the primary contact for the Project Manager as well as other senior-level Clinical Monitoring colleagues regarding development and implementation of the study startup plan, as well as identification of staff needed to effectively complete the study.
8. Represent the department during project meetings at the request of the Project Manager.
9. Perform other duties as required by the Department. Chiltern is committed to providing equal employment opportunities.
Job Requirements Education & Experience
BSc or BA degree in a biomedical or related life science, or nursing qualification preferred.
Minimum 4+ years of experience in clinical research, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job. Previous leadership experience in start-up or similar discipline. Experience of the clinical research process and terminology.
Experience using a clinical trial management system. Experience as a mentor, trainer, line manager. Skills and Attributes Ability to maintain confidentiality of employee data and information during interactions with staff at all levels.
Solid understanding of electronic tools and systems used in the submissions process.
Proficiency with MS Office programs.
Demonstrated ability to conduct start-up activities effectively, efficiently and with the minimum of supervision.
Thorough knowledge with CA and IRB/IEC and any other country specific authority/body submissions in assigned countries.
Good clinical knowledge with an understanding of medical terminology, basics of physiology and pharmacology.
Ability to communicate effectively in English, as well as the national languages of applicable countries .
Understanding of the principles of ICH GCP and regulatory requirements. Please note: applications that do not meet the criteria stated above may not receive a response
In the US, Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities, and candidates with military service
1016 W 9th Ave, King of Prussia, United States
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