Medical Operations Manager

Recruiter
Synexus Limited
Location
Cardiff (Caerdydd)
Salary
£73k - £80k (DOE/neg) + up to 30% bonus paid quart
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Are you looking to advance your career in the clinical trial space? Do you want to work for a leading multinational organisation, renown throughout the industry for its meteoric rise to success and dependability to deliver on global contracts across multiple therapeutic areas and phases? Are you looking to play an integral role in the future of medicine across the globe? If so, this may be the opportunity for you:

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 instrumental managementrole in driving this organisation towards success.
Package description
Synexus has a great team of professional, smart and energetic people. We focus on continued professional development, engaging and supporting the team within inorder to reach the common goals of the business. We also offer a competitive benefits package consisting of, but not limited to, 25 days annual leave, Life Assurance, Pension scheme, Private Health Insurance*, a Target Bonus Scheme, Childcare Vouchers, a Healthcare Cash Plan, an Employees Assistance programme and a high street discount scheme.

* Dependent on role
Main responsibilities
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 DRC.

As a Medical Operations Manager you will have the duties of Principle 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 DRC and you will be also responsible for assessing and optimising screening success rates and improving patient recruitment and retention at the site.

Medical Operations Manager Duties:

* Be part of the DRC 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 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 CM and UK Senior Research Physician 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:

* Principle 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 DRCs when required
* Professional line management of all Research Physicians at the local DRC
* Mentoring all Research Physicians (RPs) at DRC
* Ensure quality and delivery at site level by cooperating with Centre Manager, UK Medical Operations Manager (UK MOM) and UK Senior research Physician (UK SRP)
* Responsible for workforce planning within areas of accountability
* Other duties as required

Ideal candidate
To be successful you will;

* 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
* Live the Synexus values

About the company
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