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Job Details

Medical Operations Manager (Hexham Hospital or Cardiff Hospital)-145091

Company: PPD
Location: Europe, Middle East & Africa-UK-England
Reference: 145091
Closing Date: 23 Jun 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Synexus, a partner of PPD, is the world’s largest site network, with more than 195 sites and 1,500 employees. We provide customers with access to more than 100 million patients in key clinical development markets including Europe, South Africa and the United States.Synexus offers biopharmaceutical and contract research organizations (CRO) an unmatched capacity to find the right patient for the right trial at the right time. ...

Requirements:

Synexus, a partner of PPD, is the world’s largest site network, with more than 195 sites and 1,500 employees. We provide customers with access to more than 100 million patients in key clinical development markets including Europe, South Africa and the United States.

Synexus offers biopharmaceutical and contract research organizations (CRO) an unmatched capacity to find the right patient for the right trial at the right time. Our global scale and world-class site network delivers unparalleled capability, including data-driven site selection and activation, combined with proven patient engagement and retention expertise.

The role:

We have 2 vacancies, one is based at our Dedicated Research Site based at Hexham General Hospital, and the other at Cardiff Hospital for the position of Medical Operations Manager. These are both full-time, permanent roles. This is an excellent opportunity for an experienced medical operations manager or research physician with strong exposure to the clinical trials or pharmaceutical industry to play an implemental role in driving this organisation towards success.
 
As a Medical Operations Manager you will be accountable for the safe performance of our UK clinical studies ensuring commercial success for Synexus and professional line management of all Research Physicians at the local Dedicated Research Site (DRS).

As a Medical Operations Manager you will have the duties of Principal Investigator (PI) or Co Investigator while also managing our studies and patients locally through accepting responsibility for the sponsor research studies and ensuring ICH/GCP and local regulations are met.

You may be required to do Medical Cover or PI oversight if needed to other DRS and you will be also responsible for assessing and optimising screening success rates and improving patient recruitment and retention at the site.

Key responsibilities:

  • Be part of the DRS Operational Management team and support the Centre Manager in the delivery of safe clinical trials with focus on supporting the optimisation of the Profit and Loss of the centre with regards to recruitment revenues against projections
  • Ensure implementation of core competency framework at site level and work within the medical management matrix in order to support the training and development of the medical team
  • Assist the Head of Medical Affairs in reviewing SOPs and provide appropriate feedback
  • Managing our studies and patients locally and remotely accepting responsibility for sponsor research studies and ensuring ICH/GCP and local regulations are met
  • Responsibility for taking ownership of being prepared for the GMC appraisals process is implemented to ensure we see a positive outcome
  • Reviewing screening, pre-screen and screen success rates for clinical trials and cooperate with Site Manager and UK Research Physicians to ensure and optimise delivery.
  • Demonstrate leadership through the guidance and training of colleagues while working on multiple studies or multiple sites
  • Liaising with and developing positive relations with sponsors, clients and clients’ contractors as required, projecting a helpful and courteous company image
  • Constantly seeking and suggesting quality improvements
  • Other duties as required

Research Physician duties:
  • Principal Investigator (PI) or Co Investigator
  • Conducting clinical trials in line with the protocol and to ensure the recruitment of eligible participants onto the study
  • Taking responsibility for the medical wellbeing of participants during the clinical trial and referral to specialists or GP as required
  • Taking responsibility for ensuring serious adverse events / adverse events are reported appropriately Take a Lead PI role for the Core Study Team (CST) providing challenges and ideas
  • Act as cover for the sponsor or Synexus UK Chief Investigator role, where required
  • Take responsibility as a GMC appraiser if required
  • Participate in internal audits where required
  • Medical cover of other DRS's when required
  • Professional line management of all Research Physicians at the local DRS
  • Mentoring all Research Physicians at the DRS
  • Ensure quality and delivery at site level by cooperating with Site Manager, UK Medical Operations Managers and UK Research Physicians
  • Responsible for workforce planning within areas of accountability
  • Other duties as required

Qualifications

Qualifications and Experience:

To be successful in the role of Medical Operations Manager, you would ideally:
  • Be a GMC registered doctor with a number of years of previous experience within clinical research
  • Have extensive research experience demonstrating expertise in clinical research
  • Have working knowledge of GCP (ICH/GCP and local regulations compliance)
  • Demonstrate leadership skills at a site level
  • Follow study protocol’s and Standard Operating Procedures (SOP’s) at all times
  • Act courteously and politely when dealing with patients, responding to any concerns or complaints in accordance to company SOP’s
  • Provide practical help and guidance to all colleagues at site, providing practical solutions for any problems to support their development
  • Demonstrate proactive behaviour to optimise the use of your time
  • Exercise meticulous attention to detail in recording patient information and data ensuring any queries are acted upon in a timely and efficient manner
  • Ensure all study documentation is completed, signed off and actions as appropriate
  • Maintain a professional attitude and appearance at all times to colleagues and patients
  • Communicate all decisions and actions with your colleagues, demonstrating a helpful and flexible approach
  • Take ownership for your own personal development by keeping abreast of medical literature


Synexus UK

In the UK, we have a network of primary and secondary care dedicated research sites with access to 24 million potential patients. The sites act as a hub through strong relationships with GPs in each location.
The UK has nine Dedicated Research Sites including two hospital sites in Hexham and North Tees.  This gives us access to secondary care patients, doctors and facilities.  We are now developing our UK partnerships to expand our therapeutic service offering in the UK.

Synexus UK employs experienced clinical teams, with approximately 23 doctors and 35 nurses professionally trained and dedicated to conducting clinical research.  The focus of our clinical and support teams is to deliver studies to time and to target. We have a proven track record of providing retained, quality patients to meet the requirements of sponsor studies.  Our integrated teams are dedicated to ensuring our patients receive excellent attention to safety and other needs, while ensuring we deliver a high quality service to customers.

 

 

www.synexus.com

www.ppdi.com

 

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Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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