Senior Manager Clinical Operations Job – Hertfordshire, UK

Ben Traies at CK Clinical is currently looking for an experienced Senior Manager Clinical Operations to permanently join a large global Pharmaceutical company based in Hertfordshire.

As Senior Manager Clinical Operations, your role will involve leading the multi functional study team, co-ordinating activities and working closely with other team members including Therapeutics, Data Management, Biostatistics, Regulatory and Pharmacovigilance.  You may also be required to lead study teams for both regional and global studies, which will involve:

  • Working closely with and act as coordinator for the cross-functional study team
  • Selection and management of CROs and Technical Service Providers (TSPs)
  • Ensuring that study is conducted in accordance with ICH/GCP guidelines, local regulatory requirements and SOPs/WPs and in accordance with agreed timelines.
  • Ensuring quality of data are acceptable and suitable for regulatory submission.
  • Involved in training internal staff and CRO staff for the study (if required)
  • May undertake co-monitoring visits with CROs when appropriate
  • Communicating effectively with upper management both orally and in writing and set and track the study progress and budget using validated clinicaltrial management tools and systems.

 

Apply now

For more information, please contact Ben Traies at CK Clinical on 01438 870021 or email btraies@ckclinical.co.uk.Please quote reference CL22322 in all correspondence.

Click here to apply online now!

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Chinese Investment to Boost British Pharma Industry

Medical Research Care Technology is in negotiations with Chinese authorities to save up to 850 pharmaceutical jobs within the UK, the Financial Times reports.

David Tapolczay, the head of MRC Technology has said that “this is probably the most significant thing to come along in research and development in the UK for 25 years”. The negotiations centre around the hiring of specialists being made redundant from Pfizer plant in Sandwich – reported on here – which will lose up to two thousand jobs.

Under the proposed agreement, a UK based clinical research team would begin testing and developing new medicines. The project is designed to keep specialists within the UK whilst also helping to expand China’s growing pharmaceutical industry.

Added to the Chinese government’s investment will be that of British private investors and a guarantee from Chinese businesses to sell the drugs developed.

Interested in a job within the pharmaceutical industry? Start looking now by clicking here

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Clinical Education Manager Job (Permanent) – Berkshire, UK

CK Clinical are recruiting for a Clinical Education Manager to join an established Pharmaceutical company in Berkshire.

You will be working as an integral part of the Renal Marketing team. In your daily activities you will support the Medical Affairs department in the management of all renal research programmes and key opinion leader development in the UK, in line with the renal marketing plans. You will act as clinical expert and support the regional account teams and clinical managers.

Key Responsibilities:

  • Lead, develop and manage all renal clinical education programmes in the support the regional account teams with bespoke training programmes for Nephrology SpRs and Renal Nurses.
  • Support and facilitate the growth and development of the Kidney Education Network in collaboration with the committee.
  • Develop and maintain innovative educational programmes for home dialysis therapies utilising on-line and digital platforms including on-line PD academy and the “I’d rather be at home” website.
  • Map current key opinion leaders for Home Dialysis therapies and identify future directions for their development.
  • Identify recently appointed nephrologists and nurses who could be developed as key opinion leaders.
  • Design development plans for individual key opinion leaders in line with business requirements and strategy and together with account teams and marketing colleagues implement these plans.
  • Together with the Medical Affairs department and marketing team, assist in the development, implementation and follow-up of medical advisory boards.
  • In conjunction with Medical Affairs ensure on-going management of company funded research projects.
  • Raise awareness in the renal community of the CEC and EMGP grant application processes.
  • Continually review and evaluate on-going research in the UK renal community and globally to ensure appropriate communication of relevant studies and collaboration where appropriate.
  • Manage and develop the Unplanned Start Patient Education Programme (UPS).
  • Together with European Marketing, develop the existing UPS tools to be appropriate for use in planned start patients.
  • Maintain, develop and gain ABPI approval for patient education tools as required and in line with UK marketing strategy.
  • Development and execution of marketing powerhouse plan together with marketing team.
  • Marketing support to Assisted APD programme.
  • Dissemination of marketing plans to field teams via National Sales meetings and regional account planning meetings.
  • Internal training for all Renal team (new and existing) as required.
  • Support with meetings and conferences.
  • Support clinical team with CQI programmes.
  • Development and updating of patient education materials as required.
  • Budget responsibility for all clinical education programmes.

 

Benefits:

Successful candidates will enjoy the benefits of working with a global Pharmaceutical company, including a COMPETITIVE SALARY, HOLIDAYS, and CAREER PROGRESSION.

Qualifications:

  • Science degree or equivalent.
  • Nephrology nursing or medical qualification.

 

Apply Now

For more information or to apply for this Clinical Education Manager job, please contact Hendre Moolman at CK Clinical on 01438 870 023 or email hmoolman@ckclinical.co.uk.

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Novartis to Reduce UK Drug Development

As reported by the BBC, The Swiss-based pharmaceutical company, Novartis are reportedly planning to close their drug development and manufacturing operations in Horsham, West Sussex.

This site currently employees 950 staff and this is set to reduce to 400 within just two years. It produces approximately 60 different formulations of drugs. Staff will be retained who work on developing respiratory drugs in Horsham. Those focused on gastrointestinal medicines will be relocated to their units based in Cambridge, Massachusetts and Basel in Switzerland.

The announcement comes after a series of cuts by pharmaceutical companies across the UK. Including, Pfizer who are to close their research and development centre in Sandwich, Kent – potentially cutting up to 2,400 posts. In addition, both AstraZeneca and GlaxoSmithKline are shutting down sites across the UK.

Novartis have disputed the notion that their plans to close the Horsham site is linked to the decline in attractiveness of the UK in terms of innovation. General Manager, Sue Webb stated, “With significant changes in healthcare systems aimed to contain or cut cost, this critical assessment and the subsequent potential changes to the Novartis UK organisation are key to maintain significant investment in innovative drugs and our research efforts in the UK.”

The Swiss-based pharmaceutical company plan to maintain their manufacturing sites based in Grimsby, Liverpool and Dundee.

Are you looking for a new position in the UK Pharmaceutical Industry? Click here to search our current jobs now.

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CK Clinical to Exhibit at the ICR Conference 2011

CK Clinical are proud to announce that we will be exhibiting at the ICR 32nd Annual Conference on the 21st – 22nd March at the Brighton Hilton Metropole.

Here at CK Clinical we are big fans of the ICR Conference as it provides a great opportunity to not only learn about the latest developments in clinical research and but also to network with professionals in the area.

Our specialist Consultants Jim Gleeson and Ben Traies will be representing CK Clinical at the event. Please come and say hello, our stand number will be 35. If you would like to schedule in a meeting to discuss possible recruitment requirements or job opportunities, please email Jim at jgleeson@ckclinical.co.uk.

We look forward to seeing you there!

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Our Current Clinical Jobs…

Are you looking for a new position in the pharmaceutical industry? CK Clinical can help you.

We are the specialists in clinical recruitment and are currently recruiting for the following positions:

 

  • Senior Clinical Quality Assurance Auditor, London

An experienced GCP auditor is required for this permanent role in which you will audit clinical trial sites and laboratories in support of early phase oncology studies. GCLP experience will be advantageous.

  • Clinical Research Nurses, North West

A large number or Research Nurses are required to support a major study with a large, global pharmaceutical company. These will be long term contract positions at good daily rates.

 

  • Senior CRA, Home Counties

A permanent position with a US biotechnology company to monitor orphan disease studies in the UK and Europe. Candidates will require strong monitoring experience and must be willing to travel extensively.

 

  • Clinical Research Scientist, London

A long term contract position with a blue chip pharmaceutical company. Suitable for an experienced CRA or SCRA, this role will involve site monitoring and project management for complex vaccine studies.

 

  • Clinical Supply Coordinator, Cambridge

Working for a very successful biotechnology company you will coordinate packaging and labelling activities for Clinical Trial Materials being used in global studies. A permanent role with good salary and benefits package.

 

  • Senior Associate Study Management, Cambridge or Uxbridge

An excellent opportunity for a Lead CRA/Junior Clinical Project Manager to progress into a junior Study Management role. Based in Cambridge or Uxbridge, you will be employed under an initial 12 month contract.

For more details regarding any of the positions outlined above, please contact Jim Gleeson at CK Clinical on 01438 743 047 or email jgleeson@ckclinical.co.uk.

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Senior Pharmacovigilance Job – Hertfordshire UK

We are recruiting for a Senior Pharmacovigilance Specialist to join an established Pharmaceutical company in Hertfordshire, UK.

 

In this Senior Pharmacovigilance Specialist role you will be responsible for case management activities for Post marketing and Investigational products.

In the absence of the Pharmacovigilance Country Lead, you will be responsible for overseeing and managing the day-to-day activities of the local countryoperations Pharmacovigilance Department.

 

Key responsibilities:

  • Translate and process spontaneous and solicited / clinical trial adverse events reports from their country/territories and enter them into the Global Safety database or forward to a designated data entry centre or contractual partners
  • Conduct reconciliation of adverse events reports received from other company operating units and contractual partners, as applicable
  • Submit, as applicable, spontaneous and solicited / clinical trial individual case safety reports (ICSRs) from their country/territories to the local Health Authorities
  • File, store, and archive safety-related data
  • Serves as back-up coverage in the absence of the Pharmacovigilance Country Lead to ensure business continuity
  • Serves as the local Deputy Qualified Person for PV for their country in the absence of the local Qualified Person for PV when delegated
  • Comply with PV regulations and Global Safety policies/procedures and when needed take corrective action
  • Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for late reporting within their country/territory
  • Prepare for audits/inspections for their country/territories and participates in the audit and/or inspection
  • Identify and communicate potential safety issues
  • Deliver training to PV staff and customer facing non-PV staff and distributors
  • Train and mentor PV staff
  • Complete and document required PV training within required timelines
  • Serve as the point of contact for the local Health Authority or liaise with the Global Regulatory Affairs (GRA) / Global Medical Affairs (GMA) colleagues for questions from the Health Authorities regarding safety and ICSRs in absence of the Pharmacovigilance Country Lead
  • Liaise with the Country Leaders and colleagues in Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to ensureprocesses are in place for activities that are performed by those functions which impact PV
  • Liaise with the EU QP PV in consultation with Global Safety Regional Leader or Global Safety MoW / EU – Leader in the absence of the Pharmacovigilance Country Lead
  • Liaise with PV Regional Centres/Data Management Centres
  • Participate on corporate sponsored committees and councils in the absence of the Pharmacovigilance Country Lead
  • Represent the company at external safety meetings

 

Qualifications & Experience

  • The incumbent must have a health, life science, or medical science degree or equivalent by experience and be fluent in English while proficient in local language.
  • He/she should have proven industry experience in pharmacovigilance.
  • The Senior Pharmacovigilance Specialist must have extensive knowledge of Pharmacovigilance regulations in their country/territory.
  • He/She is expected to have strong communication and time management skills and have the ability to work independently with minimal supervision.

Apply Now

For more information or to apply for this Senior Pharmacovigilance Specialist position, please contact Hendre Moolman at CK Clinical on 01438 743 047 or email hmoolman@ckclinical.co.uk

Entitlement to work in the EEA is essential. Please quote reference CL21224 in all correspondence.

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Senior Data Manager Job

Department: Global Development Operations Department

In this role you will:

  • Participate in study teams and all related meetings for assigned protocols
  • Prepare documents and ensure tools are arranged to allow for data capture and data cleaning
  • Ensure delivery of a clean database
  • Run and oversee a project or set of studies within a project under supervision of a higher level data manager, which may include outsourcing and CRO oversight for studies for which Data Management activities are done by a CRO
  • Instruct, communicate and coach others on data management procedures (lower level data managers, but also providing training to and creating guidelines for monitors and site staff/ investigators)
  • Ensure compliance with EMEA, FDA and ICH regulations and policies, including validation deliverables

Your personal qualifications:

  • BS/BA degree in a biological science, health-related, or computer science field.
  • 7-10 years related experience in pharmaceutical, clinical research or health services industry with at least 4 years of experience with Data Management in the pharmaceutical industry
  • Demonstrated knowledge of medical terminology, personal computers, database structures and database management software
  • Problem solving attitude and analytical skills
  • Capable to work in multidisciplinary and international teams
  • Excellent communication, planning & organizing skills
  • Experience in working with EDC/ePRO tools

For more information, please contact Priya Mukherjee at CK Clinical on 01438 743 047 or email pmukherjee@ckclinical.co.uk.

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So You’ve Just had Your Interview…What Next?

iStock_000003154367MediumSo you’ve just walked out of your interview, you breathe a sigh of relief, kick back and relax. But be warned – the hard work isn’t over yet! Here are a few hints to help you follow up your interview like a true professional and give you the edge over your competitors:

  • Ask the interviewer when they are planning to make a decision.
  • Thank the interviewer for their time.
  • Whilst you are waiting for feedback – continue with your job search.
  • Write a short and polite thank you note to the employer/recruitment consultant – make sure you don’t make any spelling mistakes!
  • After your interview, take some quiet time to sit and write down your thoughts regarding the interview – this will help you to analyse the interview and see where you could make improvements next time.
  • Give your Recruitment Consultant a call to tell them how the interview went and take this opportunity to reiterate to them how interested you are in the role.
  • Don’t panic if you don’t hear back from the employer or your Recruitment Consultant immediately.

 

Found this useful? See below for more helpful careers advice from CK Clinical:

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EU Business Development Executive – Home Counties

  • Permanent
  • Very attractive OTE

An expanding international clinical services provider is looking for an EU Business Development Executive to be based in the Home Counties, UK.

 

Responsibilities:

Reporting to the BD Manager in North America, as EU Business Development Executive, you will work quite autonomously to:

  • Identify, establish and develop new prospects across the EU
  • Identify, develop and implement marketing and promotional activities
  • Identify the appropriate bid defence teams and prepare and lead sales presentations
  • Maintain high visibility with clients through regular surveys, meetings and participation in conferences

 

Skills & Experience:

The ideal candidate for of this EU Business Development Executive position will have the following skills and experience:

  • A strong sales background within an early stage clinical environment
  • Strong communication, organizational and presentation skills
  • Ability to travel around 25% of the time
  • Ability to handle multiple projects simultaneously

 

Apply Now

For more information, or to apply for this EU Business Development Executive position, please contact Jim Gleeson at CK Clinical on 01438 870027 or email jgleeson@ckclinical.co.uk.

Alternatively, click here to apply for this EU Business Development Executive position online now.

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