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Job Details

Clinical Study Manager (Clinical Project Manager)

Company: Chiltern
Location: Surrey Hampshire Berkshire
Reference: MLJ899808
Closing Date: 22 Mar 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Home or Office Based (Camberley - junction 4 off the M3) - Full Time or 4 days/week - Pure Project Management - No Monitoring!

Requirements:

Job Background

Excellent Home Based Permanent Clinical Project Manager/Clinical Study Manager level opportunity - FULL TIME or Part Time 4 days/week

 

  • Company officially certified by the Top Employers Institute for its exceptional employee offerings for the fourth consecutive year, and for the first time, Top European Employer
  • Field Based or Office Based (Camberley)
  • General Medicine
  • Competitive salary and benefits
  • Full support and a focus on development
  • Free access to training
  • Great team of people
  • Would suit an experienced Local (UK) Clinical Project Manager
  • NO MONITORING - PURE CLINICAL PROJECT MANAGEMENT
  • Ideally you will be situated in the South East UK/Surrey/Greater London
  • Permanent employment with Chiltern - seconded to a top ten pharmaceutical company
  • 12 Months rolling contract
  • PAYE salary and a range of benefits

 Full Job Description

We have an excellent opportunity for a seasoned Clinical Project Manager to work with a top ten pharmaceutical company. This is a home/office based (mix) based full time or part time (4 days) CPM position based in South East UK. Chiltern have enjoyed a long and partnered approach with our pharma partner and both organisations are focused on the wellbeing and career development of the individual

You would be permanently employed by Chiltern on PAYE salary and benefits, and seconded to our client (pharma partner). We offer a competitive salary, car/car allowance, pension, LI, 25 days leave (increasing to 30) and other pastoral/quality of life benefits including contributions towards health club membership. Pro rata'd benefits and salary based on part time working (three or four days)

We are looking for a dynamic project manager – and someone who is interested in career development and appreciates the benefits of being “employed” for example, career development opportunities hand in hand with Chiltern and our client.

You will receive full support in terms of line management/pastoral care, full administrative support, and access to excellent training in both soft skills and technical advancement courses.

Working within a range of therapy areas this is a rolling and renewable contract starting as a 12 months secondment.

  • Planning, executing and reporting on a number of Phase I-III and global phase IV clinical studies for the UK, from planning and site feasibility through study close-out

  • Lead local project teams and liaise with global study teams

  • Deliver studies to time, target and budget

  • Facilitate preparation and submission of EC application and amendments

  • Liase with regulatory affairs to faciliate CTA application and amendments

  • Prepare, submit and manage study budget on an ongoing basis to maintain cost

The local study manager is accountable for planning, executing and reporting on a number of phase I-III, global phase IV clinical studies for a country, from planning and site feasibility hrough to study close-out, in compliance with processes and regulatory requirements.

Recognize potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate

Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel.

In liaison with the global clinical team, assist in the development of local trial execution plan and timeline commitments for a country.

 Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.

Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.

Coordinate and manage the site selection process in collaboration with the necessary line units.

Ensure sites are prepared for “Ready to Initiate Site” (checkpoint). Obtain written confirmation about availability of global documents.

Ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person.

Provide training as needed for monitors and any other activities that support site readiness to recruit.

Ensure documentation of training (global/regional/local IM minutes, participants’ lists, certificates, etc.) is archived appropriately.

Drive the conduct of the trial, track and oversee progress and status.

Ensure all operational aspects are on schedule.

Oversee local clinical team activities to achieve trial timelines and quality execution according to standards and local and international regulations.

Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues. Appropriately escalate issues in a timely manner and ensure resolution.

Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.

Lead and chair local study team meetings, attend and participate in global clinical trial team meetings.

Track trial budget with appropriate trial budget responsible in country. Oversee TCF preparation and submission to COM.

No direct reports but leads a team in a matrix organization. Makes decisions relative to country participation and commitments. Resolve issues with minimal supervision and understands when to escalate. Number of trials to manager depends on volume of trials in countries and local organisation. Manages a maximum of 100 sites or up 12 trials

Please call Marc Joseph on 01753 216664 for futher information or send CV to marc.joseph@chiltern.com

key words clinical project management, clinical project manager, clinical study manager, clinical study management

 

 

5 years’ strong experience in clinical research

Experience in a monitor role or a role overseeing clinical trials

Strong Interpersonal skills

Strong Project Management and leadership skills

Working experience in a global team, team player

Ability to work under pressure

Salary

On Application

Position Type

Permanent or Contract
Full Time or Part Time

Contact

Email Marc Joseph - marc.joseph@chiltern.com
01753 216664

Apply for this job: Clinical Study Manager (Clinical Project Manager)

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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