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 Site Manager II

Company: PAREXEL
Location: Belgium
Reference: 40179BR
Closing Date: 24 Jul 18
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

The Clinical Site Manager (CSM) is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. ...

Requirements:

The Clinical Site Manager (CSM) is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to initiation, the development of a robust patient recruitment strategy, setting up of a system, assessing compliance with regulations and the site’s capability to comply with the study needs and recruitment expectations, and problem solving to address and resolve site issues.

Your Key Accountabilities:

Start-Up (from site identification through pre-initiation)

Maintenance (from initiation through close out)

• Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
• Build relationships with investigators and site staff.
• Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
• Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
• Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
• Evaluate site recruitment plan in collaboration with the site staff on an on-going basis and provide strategy for improvements.
• Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
• Conduct remote visits/contacts as requested/needed.

Overall Accountabilities from Site identification to Close out

• Ensure timely and accurate completion of project goals and update of applicable trial management systems.
• Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
• Update all appropriate Clinical Trial Management Systems on an on-going basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF).
• Ensure that assigned sites are audit and inspection-ready.
• Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.



QualificationsEducation:

• Educated to degree level (biological science, pharmacy, or other health-related discipline).
• Fluent English, Dutch and French.

Skills:

• Sound problem solving skills.
• Able to take initiative and work independently, and to proactively seek guidance when necessary.
• Ability to interact professionally within a client organization.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
• Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
• Attention to detail.
• Holds a driver’s license.

Knowledge and Experience:

• Documented substantial on site monitoring experience (2 years +) with understanding of clinical trials methodology and terminology.



    Apply for this job: Clinical Site Manager II

    Contact Information:

    Address:  PAREXEL International
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middlesex
    UB8 1LZ
    England
    Tel:  +44 1895 238000
    Fax:  +44 1895 238494
    Website:  Visit Our Web Site
    Advertisement

    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.