Location: Cary or Wilmington, NC
Closing Date: 02 Jan 17
Type: Full Time
Salary (£): Competitive
Lead Regulatory & Site Services Specialist Full Time located in either Cary or Wilmington, NC
Lead Regulatory & Site Services Specialist
Full Time located in either Cary or Wilmington, NC
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 Lead RSS specialist will lead projects, including, project oversight of other RSS team members.
Accountabilities / Responsibilities:
1. Serve as main contact point for sponsor and project team for all RSS activities. Track and report project status and deliverables to sponsor and project management.
2. Develop a start-up & submission strategy in conjunction with sponsor and project manager and ensure start-up deliverables are completed within agreed project timelines and in accordance with sponsor expectations.
3. Liaise with other groups, e.g. commercial contracts, to provide and report on an integrated start-up approach.
4. Manage and oversee RSS activities as applicable and allocated (feasibility, EC/RA submissions, essential documents collection, review and approval for initial drug or medical device release to study sites) throughout the course of the study.
5. Manage and oversee all CTAAs, CTA amendments, and End of Trial Declarations in accordance with applicable national laws and guidelines and any multi-country guidelines and regulations, ICH/GCP and company SOPs/WIs as applicable.
6. Provide oversight to other RSS team members for assigned projects and manage resource requirements within designated countries/region to ensure project needs are met.
7. Provide support to Business Development, including attending strategy calls, providing information for RFI and RFP responses, and bid defense meetings.
8. Perform other duties as required by the Department. Chiltern is committed to providing equal employment opportunities.
Education & Experience
Bachelor’s degree in life sciences, related discipline or experience in the role. BSc or BA degree in a biomedical or related life science, or nursing qualification preferred.
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.
In-depth experience with clinical trial study start-up activities and thorough knowledge of the applicable guidance and regulations. Experience in conducting feasibility pre & post-award as applicable.
Prior experience supervising regulatory and / or clinical trials staff.Prior clinical trials project management, department management or specific leadership experience, including international studies. Skills and Attributes
•Ability to maintain confidentiality of employee data and information during interactions with staff at all levels. •Proficiency with MS Office applications.
•Ability to communicate effectively in English. •Understanding of the principles of project management, ICH-GCP, and regulatory requirements.
•Recent mentoring, training and line management experience in start-up or related area.
•Solid understanding of national CTA directives, regulations and guidelines in the countries of operation as applicable.
•Solid financial and business acumen. 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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