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Job Details

Global Lead Regulatory & Site Services

Company: Chiltern
Location: Job can be filled in USA or UK
Reference: 72117-GL
Closing Date: 15 Sep 17
Type: Permanent
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

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. Must have study start up, supervisory and global experience.

Requirements:

Job Background

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.

Position can also be filled in the UK.

Position Requirements:

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.
  • Global experience is required.

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

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

DOE

Position Type

Permanent or Contract
Full Time or Part Time

Contact

Email Maria Meneses - Maria.Meneses@Chiltern.com

Apply for this job: Global Lead Regulatory & Site Services

Contact Information:

Address:  Illinois, USA
1425 Tri-State Parkway, Suite 110 Gurnee, USA
IL 60031
USA

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