Global Lead Regulatory & Site Services Specialist
Lead Regulatory & Site Services Specialists with global knowledge and experience in clinical trials needed. Position can be home based anywhere in USA or office based in Cary or Wilmington, NC; King of Prussia, PA or Bristol, TN.
Expert in project startup and/or related maintenance activities for a particular study/studies on a regional and/or global level. Responsible for leading and overseeing startup and/or maintenance activities on projects and ensuring these are on time, within budget, and in compliance with SOPs and/or other quality and regulatory requirements.
Accountabilities / Responsibilities:
1. Act as a supporting lead or main lead on designated studies depending on experience and study size.
2. As applicable (if needed with support from a more experienced RSS member), overseeing assigned start up and maintenance activities (incl. but not limited to feasibilities, site identification, site document collections, submission work, essential document- review). Maintaining close cooperation with other functional departments like Commercial Contracts and/or Clinical Operations to efficiently manage the project.
3. As applicable (if needed with support from a more experienced RSS member), provide functional leadership to the assigned RSS team and ensure satisfactory performance and completion of the project during the start-up phase and for specific tasks at other time-points in the study.
4. Continuously track progress of start-up activities on assigned projects and provide status reports to Project Managers and/or clients as required (e.g. preferably by updating CTM systems).
5. As applicable (if needed with support from a more experienced RSS member), ensure that work is performed within the budget and that study team members are aware of the RSS budget. Escalate the need for out of scope work, as applicable.
6. If applicable, act as main contact for the Project Manager and/or client for any start up and/or maintenance deliverables on the assigned project(s).
7. If needed represent the department during project meetings
8. May at times support RFP development and attendance at Bid defenses where required.
9. Develop a start-up & submission strategy in conjunction with the Project Lead, other functional groups and the sponsor to ensure start-up and maintenance deliverables are completed within agreed project timelines and in accordance with sponsor expectations.
10. Maintain oversight for RSS project required resources and adapt/request as applicable to ensure project deliverables are met.
11. Perform any other duties as required by the Department.
Education & Experience
- Bachelor’s degree in life sciences, related discipline or experience in the role.
- Minimum of 5 + years’ experience in a clinical research role with a pharmaceutical company and/or CRO, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
- Experience in leading study start-up activities and thorough knowledge of the applicable guidance and regulations.
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 applications
. Solid knowledge of start-up management activities
. Knowledge of CA and IRB/IEC and any other country specific authority/body submissions
. Ability to communicate effectively in English
. Understanding of the principles of project management, ICH-GCP, and regulatory requirements
. Solid financial and business acumen.
Please note: applications that do not meet the criteria stated above may not receive a response
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