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Job Details

Project Management Operational Lead, EMEA

Company: inVentiv Health Clinical
Location: England
Reference: 14204
Closing Date: 23 Jan 17
Type: Permanent
Salary (£): Negotiable

Job Summary:

inVentiv Health -Transforming Promising Ideas into Commercial RealityJob Title: 14204 Project Management Operational Lead, EMEAPrimary Function:As a Project Management Operational Lead you will successfully lead and manage clinical operational deliverables for Late Stage Clinical Projects. ...


inVentiv Health -Transforming Promising Ideas into Commercial Reality

Job Title: 14204 Project Management Operational Lead, EMEA

Primary Function:

As a Project Management Operational Lead you will successfully lead and manage clinical operational deliverables for Late Stage Clinical Projects.

Job Description:

* Oversee the CRA Team
* Act as the primary point of contact for the CRA team to ensure quality and meet project timelines
* Organize and lead CRA team teleconferences
* Ensure efficient dissemination of information across the CRA team
* Ensure in compliance applicable local laws, regulatory requirements and company SOPs
* Develop study specific tools for tracking and reporting to the project team and or Client ensuring quality of the project deliverables
* Maintain visibility of project(s) progress by the use of tracking tools
* Generate or contribute to study specific plans, including Project Plan, Monitoring Plan,
* Communication Plan and any major or other required plans
* Assist the Project Manager with the assessment of workload and site assignments within the CRA team
* Oversee the set-up of Trial Master File
* Review and approve visit reports for all visits conducted either on site or remotely (Pre-Study,
* Initiation, Monitoring or Close Out) for quality, ensuring finalization within the timelines mandated by SOPs or monitoring plans
* Oversee and assist the CRA Team in the resolution of data queries
* Oversee and assist the CRA Team with the management of assigned sites by ensuring that the CRA has regular contact with sites to clarify site compliance, adequate enrolment and understanding of study requirements
* Establish project level specific training requirements for the CRA team
* Prepare and deliver project level specific training
* Assist the PM in the development of any study materials that may be required and present at investigator/study launch meetings
* Interact and coordinate activities with the Feasibility, Study Start-Up, Site Contracting and applicable Data Services teams
* Provide assistance in the preparation for and participate in Audits
* Assist in the completion of TMF QC
* Act as a back up to the PM or as overall PM in a simple small clinical study
* Support operational team to review, escalate and manage quality issues
* Participate in company-required training programs
* Interact with representatives of Client or affiliates both within and outside clinical (e.g. Medical, Marketing, Commercial)
* Provide guidance to CRA Team in how to manage interactions with Client personnel if applicable
* Perform necessary administrative functions (e.g. submission of expense reports, entering time etc)

May also be required to:

* Conduct site visits, either on-site or remotely and complete the appropriate follow up
* Review and verify CRFs and other clinical data for completeness and accuracy and generate queries if applicable
* Conduct on-site or remote evaluation visits for CRA Team
* Participate in the preparation for bid defence meetings, attend and present any applicable components of the meeting


* Previous experience in Clinical Research, including clinical monitoring experience
* Knowledge of Good Clinical Practice/ ICH Guidelines
* Strong Organizational Skills
* Excellent communication, presentation, interpersonal skills both written and spoken with the ability to inform, influence, convince and persuade
* Ability and willingness to travel up to 25% for meetings and possible on-site visits if required. Overnight and occasional weekend travel may also be required

Education Required:
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience

In return we will offer:

* A competitive remuneration package with excellent benefits
* A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
* The opportunity to work within a successful and rewarding environment

Location: EMEA, home or office based.

inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry deliver new drugs and therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) is made up of more than 14,000 employees who have the ability to service clients in more than 90 countries. We offer a differentiated set of solutions designed to improve client performance and accelerate the process of bringing products to market. For more information, visit

We look forward to receiving your application!

Apply for this job: Project Management Operational Lead, EMEA

Contact Information:

Address:  Main Office
Thames House, 17-19 Marlow Road Maidenhead, Berkshire
Reasons to work for inVentiv Health Clinical
Tel:  +44 (0) 1628 408 408
Website:  Visit Our Web Site

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