Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Clinical Team Leader

Company: Chiltern
Location: Home-Based Opportunities Anywhere in the USA
Reference: LS - CTL
Closing Date: 23 Oct 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Home-based Opportunities

Requirements:

Job Background

The Clinical Team Leader provides guidance to Clinical Operations projects. Incumbents provide project-level oversight for one or more CRAs. Incumbents work cross functionally with other Chiltern departments to ensure data integrity and compliance with Chiltern International or Client’s SOPs, ICH GCP and or other applicable standards and guidelines applicable for late phase or medical device studies, regulatory requirements and the project protocol. Incumbents are responsible for ensuring that quality projects are completed on time and within budget.

 

1. With periodic guidance from line management, develop the strategy, tools, and training to oversee and assess performance of CRAs, in the conduct site visits (remote or onsite) including (but not limited to): qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs, local requirements, the protocol and project plans.

2. Communicate effectively with Chiltern Project Team members (i.e. Clinical Team Leader, Project Managers, Safety and Data Management) as well as the Sponsor Project Team (as applicable) to support study completion per company and client requirements and timelines.

3. Communicate with CRAs & study sites (and other project team members as applicable) to follow-up on all open issues, monitor patient recruitment and retention, in order to meet the project timelines. Ensure that all study-related documentation is tracked, printed, and filed as required by Chiltern SOPs, regulatory requirements, and other protocols.

4. Ensure that the general and site-specific documentation files that comprise the TMF assembled appropriately, reconciled against site files and required QC performed as specified by SOP.

5. Develop a thorough understanding of the contract and scope of work to support financial progress.

6. Perform other duties as required by the Department or Project Team.

 

  • BSc or BA degree in a biomedical or related life science, or nursing qualification
  • Minimum 0-2 + years’ CTL experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Minimum 4 + years of previous CRA experience with single and/or multi-center trials
  • For Late Phase, a minimum 4 + years of previous Late Phase In-House CRA experience or equivalent experience with single and/or multi-center studies.
  • Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors
  • Demonstrated ability to conduct clinical operations activities effectively, efficiently, and with minimal supervision. Attention to detail and methodical approach to work
  • Good understanding of medical and clinical research terminology, and clinical research processes
  • An understanding of the basics of physiology and pharmacology
  • Understanding of the principles of ICH GCP or other applicable standards and guidelines and regulatory requirements
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
  • Good oral and written internal and external communication, team and organizational skills, personal presentation. Ability to communicate effectively in English.
  • Experience using a clinical trial management system (CTMS)


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

Salary

on application

Position Type

Permanent
Full Time

Contact

Email Lauren Sigmon - Lauren.Sigmon@Chiltern.com
+1 910 350 6730

Apply for this job: Clinical Team Leader

Contact Information:

Address:  Wilmington, North Carolina, USA
2520 Independence Blvd, Suite 202, Wilmington, NC 28412, USA

USA
Tel:  +1 910 338 4760
Fax:  +1 888 301 2627
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.