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Project Manager - EP

Employer
Parexel
Location
Harrow, United Kingdom
Salary
Competitive
Start date
17 Oct 2019
Closing date
16 Nov 2019

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


The Project Manager is charged with management of phase I/II clinical trials in the Parexel Early Phase Unit Northwick Park Hospital, ensuring compliance with proposed timelines and GCP guidelines.
  • To assist in the conduct of Early Phase studies across all therapeutic areas in accordance with ICH Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP's).
  • Liaison with Parexel staff such as the study co-ordinator, Principal Investigator, Pharmacist and recruitment personnel to ensure the smooth running of Early Phase studies.
  • Liaison with Sponsor personnel ensuring communication channels are open at all times and that the Sponsor is kept adequately appraised of study progress.
  • Ensuring all study milestones are met.
  • Management of project related meetings (both internal and with Sponsor personnel) and attendance at such meetings where appropriate.
  • Liaison with Regulatory personnel regarding the timely progress of CTA applications to the MHRA.
  • Liaison with and submission of documents to Ethics Committees.
  • Development and review of study protocols.
  • Review of study related documents (including Case Report Forms) and distribution to third parties where appropriate.
  • Oversee the timelines for ClinBase set-up of studies.
  • Completion and updating of project information on ClinBase.
  • Distribution of draft documents for review, collation of comments and liaison with Sponsor.
  • Review of Informed Consent Documents and IRAS application forms in conjunction with appropriate medical personnel.
  • Set up and regular review of the Study File to ensure completeness and compliance with GCP guidelines. Contact with external sites to arrange transfer of documentation as required.
  • Management of monitoring visits, overseeing the resolution of data queries.
  • Contact with sub-contracted parties where appropriate to ensure timely study conduct.
  • Monitoring and managing the study budget.
  • Liaison with appropriate finance sections of Parexel to ensure timely invoicing.
  • Ensuring archiving procedures are initiated and followed.
  • Preparation of post-study summary report for the Ethics Committee.
  • Participate in general departmental activities to assist in continuous improvement of the department.


Qualifications

Education
  • Study of medicine, pharmaceutics, natural sciences or business. Advanced degree desirable.


Language Skills
  • Excellent communication skills through English (native or fluent).


Minimum Work Experience
  • Extensive operational (cross-functional) and project management expertise in clinical development, preferably early clinical development.
  • Proven track record as a Study / Project Manager (Phase I-II), ideally on strategic projects.
  • Proven relevant experience in healthcare, clinical research, project management or contract research organization.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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