Senior Clinical Research Associate Job – East Yorkshire, UK

Susan Murray at CK Clinical is looking for a Senior Clinical Research Associate to join a major pharmaceutical company based in East Yorkshire, UK. This is a permanent position.

The role:

As Senior Clinical Research Associate, you will be responsible for providing clinical input to designated Pharmaceutical Category Products through specification of clinical trial requirements and protocols and management of clinical trials. Further responsibilities of this role include:

  • Working in multi-functional project teams providing clinical input to deliver project requirements.
  • Representing the company in the external environment, working with CROs, KOLs, Regulators etc as required to optimise project development strategies.
  • Negotiating costs and managing payments for Clinical Trials in remit
  • Providing clinical expertise to the design of clinical trials, ensuring trial designs are appropriate to achieve the desired claims and to suggest innovative approaches to achieving the desired endpoints.
  • Ensuring that all protocols developed for pharmaceutical clinical trials address the business requirements and are fully compliant with all relevant legal and regulatory requirements and SOPs.
  • Ensuring that all clinical trials/studies are performed to the required timelines.
  • Ensuring that the relevant Clinical Affairs SOPs are implemented for all clinical trials/studies.
  • Ensuring that Investigators and Contract Research Organisations appointed to conduct clinical trials/studies are suitably qualified and experienced and to oversee the conduct of clinical trials/studies, ensuring that the required quality standards are met.
  • Reviewing, revising and writing standard operating procedures to ensure adherence to Good Clinical Practices in the conduct of Reckitt Benckiser sponsored studies.
  • Participating in meetings and conference calls with multidisciplinary study teams and vendors.
  • Liaising with quality assurance and provide input and review on data management activities.
  • Assessing potential study sites and CROs to insure that facility, staff, and patient populations meet Reckitt Benckiser’s study needs.
  • Planning and executing study start up meetings.
  • Reviewing and finalising clinical monitoring reports and report to project teams any significant issues.
  • Meeting with clinical investigators and their staff to insure that all aspects of the study are understood, and all required documentation is complete before initiating the study.
  • Managing Clinical Research Associates (in-house or contract) to monitor study progress to assure compliance with protocol requirements, applicable FDA/ICH regulations, Good Clinical Practices, and contractual agreements; review and verify monthly contractor invoices.
  • Managing Clinical Research Associates (in-house or contract) to ensure clinical supplies and test articles for appropriate storage, full drug accountability, proper destruction at the end of the study, and ensure that no product is diverted to an inappropriate use.
  • Conducting audits that include source document review, and insure timely, accurate, and complete CRF collection during the study and at study completion.
  • Ensuring adverse events are filed appropriately with Pharmacovigilance.
  • Assisting the clinical sites in preparing for possible FDA inspection.

The ideal candidate:

To be considered for this Clinical Research Associate role you will possess:

  • The ability to work effectively with minimal supervision and capability to multitask and move competently among various tasks.
  • An In-depth understanding of current Good Clinical Practices and regulations relating to clinical research.
  • Clinical development experience in a pharmaceutical development environment.
  • Strong and well developed motivational and interpersonal skills.
  • A clear and logical thinker with the ability to recognise patterns and develop innovative solutions.
  • Ability to develop and communicate argumentation in order to influence externally and internally.
  • Flexibility of thinking in order to facilitate working with many different professional disciplines.
  • Pro-active self-direction with a high level of initiative and persistence.
  • Understanding priority setting and project management.
  • Strong analytical skills with the ability to implement plans.
  • Strong communication skills, both written and oral.
  • A willingness to explore new and previously uncharted territories and an openness to change and ability to think out of the box.
  • Results oriented, entrepreneurial and self-motivating.
  • The capability to build strong working relationships to deliver outstanding results.
  • BA/BS (or advanced degree), preferably in a scientific discipline relevant to health sciences
  • A minimum of 5 years of clinical research experience, two of which must have been as a Clinical Research Associate.
  • Experience in study design, scientific methods, and field monitoring practices from drug/medical device development.
  • Certification by the Association of Clinical Research Professionals or a similar organization.
  • Experience managing CRAs and CROs.
  • This position requires travel (up to approximately 30%).

How to apply:

For more information, or to apply for this Clinical Research Associate position, please contact Susan Murray at CK Clinical on 01438 743 047 or email smurray@ckclinical.co.uk.

Click here to apply online now!

 

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Synexus to Begin MCI Studies

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Manchester based Synexus, a company specialising in the running of clinical trials on behalf of pharmaceutical companies, has gained a contract to conduct a mild cognitive impairment (MCI) study, reports pharmaceuticalbusinessreview.com.

Synexus, who work with pharmaceutical, biotech and CRO companies globally, signed an agreement late in 2010 with Roger Bullock to develop effective clinical trials in the MCI field. The company is in negotiations with a number of clients to undertake further trials.

CEO Christophe Berthoux has seen an increase in those who are looking to involve themselves and invest large amounts of money into novel MCI treatments. Berthoux believes his company is seeing this increase because “sponsors want to partner with clinical trials companies that actually deliver the number of patients needed to get their study underway.”

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Multiple Myeloma Treatment Recommended by NICE

Celgene’s Thalidomide has been recommended for use in treatment for multiple myeloma patients, reports pharmatimes.com.

The National Institute for Health and Clinical Excellence (NICE) says a combination of Thalidomide, an alkylating agent and a corticosteroid as they delay the disease’s progression and improve patient life expectancy. The combination is to be used in patients for whom chemotherapy is deemed unsafe or inappropriate.

The lack of a cure for this type of cancer means that any new treatments are going to be beneficial to the 4,000 people who are diagnosed annually. The price of £2,100 per treatment cycle of Thalidomide is also significantly less than similar treatments.

The NICE recommendation should mean that Celgene’s drug is used to treat those with multiple myeloma soon.

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Pfizer Strike Deal With Scottish Stem Cell Company

Roslin Cells, of Scotland, has made an agreement with Pfizer to give access to Roslin’s pluripotent stem cells and assess their clinical viability, reports pharmatimes.com.

No details of the deal were disclosed, in terms of financial transactions, though it gave Aiden Courtney, CEO of Roslin, the opportunity to say his company have had the chance to establish “the capability to derive new stem cell lines to the standards required for their use as the starting material for a clinical therapy.”

Pfizer is evaluating the use of the stem cells for potential use in clinical trials, something Courtney is “delighted” to say. Pfizer has shown interest in stem cells, both for use in clinical trials and as a therapy, and following the launch of Roslin’s Cell Therapy Partner Programme in October 2010, offering commercial access to therapies and expertise in stem cells, the company seemed to feel the opportunity was too good to pass up.

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Abbott’s to Aid WHO in HIV Development

Clinical researchers at Abbott’s are to develop two HIV drug formulations, according to prnewswire.com.

The development is designed to assist with the World Health Organisation’s Treatment 2.0 strategy. Abbott is to create new therapies to allow for greater convenience to patients and doctors in third world countries, such as turning a current treatment into a powder format so that it does not need to be refrigerated and can be taken with food or water.

Dr Scott Brun, vice-president for infectious diseases at Abbott’s, says the new research programme “confirms our continued commitment to develop and provide effective, quality HIV medicines.”

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Pharma Hiring Still Slow

KPMG have surveyed over 100 pharmaceutical executives and have discovered they are expecting difficult time ahead, reports fiercepharma.com.

Over 80% of pharmaceutical officials expect their companies to be bought or to buy in the next few years, as companies look to expand into the emerging market and also look to combat revenue losses caused by increased generic competition.

30% have predicted that economic recovery will be complete by the end of 2012, though a much less optimistic 27% add another two years to that forecast. Companies have money to invest and buy new medicines, though it seems that growth is not as possible from within.

Hiring is not looking greatly positive either; with only 40% of pharmaceutical executives expecting to hire new staff in 2012.

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Lilly Plans Large Cialis Sales

Eli Lilly is looking to overtake Viagra with new pharmaceutical Cialis as market leader, reports reuters.com.

John Lechlieter has said that “This year [Cialis sales] will overtake Viagra in terms of numbers of prescriptions worldwide.” The drug is also expected to be used for other problems, such as prostate enlargement.

Cialis is yet to be granted market approval, though is expected to gain it, in the US at least, by the end of the year.

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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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Sanofi Split and Successful Drug Trials

Reuters.com has reported that Sanofi has successfully agreed a deal to sell its dermatological department.

Valeant Pharmaceuticals is to acquire the Dermik skincare business for $425 million, making Sanofi the latest pharmaceutical giant to shed non-central sectors, following Pfizer’s recent announcement (here). Sanofi’s chief executive has said the sale allows them to “improve [their] focus on core businesses.”

Sanofi also announced that phase III trials on its experimental multiple sclerosis drug are encouraging, as it reduces relapse rate in the condition. More results are expected in the fourth quarter of 2011.

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Ferring Pharma Moves Head Office

Ferring Pharmaceuticals has moved its UK Head Office from Slough to West Drayton, near London, reports inpharm.com.

Ferring has said it is committed to developing its UK franchise. UK General Manager Steve Howson announced that the new headquarters represented “a substantial investment in [Ferring’s] business operation and will provide [their] personnel with significantly improved facilities.”

The firm last year recorded 1 billion euros in global sales and the new offices have space for 50 employees.

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