Featured Jobs

Biostatistician – Belgium

Friday, May 24th, 2013

Mylene Paumier at CK Clinical is currently recruiting for a Biostatistician to work for a leading pharmaceutical organisation in the EU on a contract basis.

Responsibilities

Your responsibilities will be to:

  • Be responsible for statistical aspects of clinical and pre-clinical research projects including study design, sample size estimation, patient randomization, case report form development, writing statistical analysis plans, statistical analysis and interpretation of data, and reporting of results.
  • Work with SAS programmers as part of a biostatistics team.
  • Knowledge of applied parametric and nonparametric statistics, strong SAS programming skills, and the ability to translate client needs into statistical practice and the ability to educate clients in the use of statistics are essential.

Skills

  • Excellent written and oral communication skills
  • Knowledge of Microsoft Office applications
  • Excellent interpersonal skills, great understanding of team-culture. Demonstrate a nature of proactively, enthusiasm, independent drive, and energetic outlook to tasks
  • Exceptional organizational skills, Works towards and meets deadlines
  • Ability to collaborate, build strong partnerships/relationships with all stakeholders

Qualifications

  • Masters Degree in Statistics or PhD in Statistics or related field.
  • Basic knowledge of SAS programming and at least some other significant statistical software (e.g., S-Plus, PASS).
  • Demonstrated written and oral communication skills.

How to applyMylene Paumier - European Recruitment at CK Clinical

Apply online now

 For more information or to apply for this position please contact Mylene Paumier on 0207 470 5672 or email: mpaumier@ckclinical.co.uk.  Please quote reference CL26926 in all correspondence. Entitlement to work in the EEA is essential.

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Pharmacovigilance Physicians Needed!

Tuesday, May 21st, 2013

CK Clinical currently has some exciting opportunities  for experienced Pharmacovigilance Physicans to join world renowned progressive pharmaceutical companies. All of these roles offer highly competitive salaries with excellent benefits.

 

Here are a

few example of these roles:

Director PVG

This is an excellent opportunity for an experienced PVG MD to move into a progressive Pharma company with  innovative products and pipeline.

 

Deputy QPPV

An exciting opportunity has arisen for a Deputy EU QPPV to join a prestigious pharmaceutical company based in the South East.

 

To find out more about these roles and our other Pharmacovigilance Physician jobs, please contact Moin Din in the first instance on 0207 470 5675 or email mdin@ckclinical.co.uk.

 

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Pharmaceutical Jobs of the Week – 20 May 2013

Monday, May 20th, 2013

Here are our pharmacuetical jobs of the week for the 20th of May 2013:

 

Clinical JobsClinical Operations:

Clinical Trials Assistant - London

Associate, Supplier Performance - Cambridge

Clinical Compliance and Training Manager - Home counties

 

Regulatory

Affairs:

Regulatory Executive Worldwide Safety -Surrey

Director, CMC, Regulatory Affairs - Hertfordshire

UK CTRL Coordinator - South East

Senior Associate GRAAS Operations - Cambridgeshire

 Pharmaceutical jobs

Jobs in Europe:

Operational QA Manager - Switzerland

Head Allocation Recruit.Mger - Switzerland

Biostatistician - Belgium

 

Pharmacovigilance & Medical Information:

Pharmacovigilance Officer - South East

 

Biometrics:

Senior Statistical Scientist - South East

SAS Programmer  – South East

UK Regulatory Professional - Buckinghamshire

 Clinical Jobs

Medics:

PD Clinical Director

 

Not quite what you’re looking for?

Click here to register your CV with CK Clinical today.

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Expert Clinical Manager – Switzerland

Tuesday, May 14th, 2013

Mylene Paumier at CK Clinical is recruiting for an Expert Clinical Manager to join a global pharmaceutical company at their site based in Switzerland on a permanent basis.

Responsibilities:

As Expert Clinical Manager, your responsibilities will include the following:

  • Responsible for operational aspects of one or more clinical trials (phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use) under the leadership of the CTH. Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned with an entrepreneurial approach which requires the ability to multi-task on a wide spectrum of activities with an overall external focus
  • Contributes to or manage simple clinical trial with minimal supervision by providing input and contribute to the development of protocols and related documents, in the on-going scientific review of clinical data, and in trial data analysis, reporting and publishing. Prepare training materials and presentations related to the planning and conduct of the trial.
  • Manage simple clinical trial under supervision from the senior clinical operations team. Write CTT meeting minutes. May deputize for the CTH at certain meetings. Ensure all assigned operational trial deliverables are met according to timelines, budget, operational procedures and quality standards, SOPs and Business Guidance.
  • Contribute to the on-going scientific review of the clinical data and support trial data analysis, reporting and publishing.
  • Assist in preparation of clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget
  • Support the development, management and tracking of trial budget working closely with the appropriate

    partners. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.

  • Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, safety updates, etc….
  • Participate in the on-boarding and training of new staff. May serve as faculty member for training programs

Qualifications:

As Expert Clinical Manager, you will have the following qualifications, skills and experience:

  • Degree in health or life sciences. Fluent English oral and written skills
  • Technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
  • Proven ability to work independently and ability to collaborate and work effectively in teams.
  • Demonstrated ability to support more than one clinical trial
  • Thorough knowledge of Good Clinical Practice and clinical trial design. Immediate statistical and regulatory process knowledge required
  • Basic knowledge of haematology/oncology/endocrinology therapeutic areas is preferred

    Mylene Paumier - Biometrics Recruitment at CK Clinical

    Please contact Mylene for more details.

How to apply:

For more information or to apply for this Expert Clinical Manager position, please contact Mylene Paumier on 0207 470 5672 or email mpaumier@ckclinical.co.uk.  Please quote reference CL26592 in all correspondence.

 

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Clinical Outsourcing Manager – Home Counties

Friday, April 26th, 2013

Jim Gleeson is recruiting for a Clinical Outsourcing Manager to be based at the Home Counties offices of an international pharmaceutical company. This will be a long term role, running until November 2014.

Responsibilities

Your role will be to coordinate daily outsourcing activities through the evaluation and selection of vendors, negotiation of vendor budgets and contracts, and management of ongoing vendor relationships for clinical studies conducted by a wide variety of

third party organisations.

Specific duties will include:

  • Serve as the primary contact to the members of operational teams for supporting the outsourcing of their studies/projects. Advising and supporting project teams in the identification and selection of suppliers for outsourced services.
  • Pre-screening of suppliers according to the study requirements and the preparation of Requests for Proposal to support these requirements.
  • Management of the relationship with CROs and other key vendors to ensure timely delivery of high quality services in a cost efficient manner.
  • Assimilation of proposals and responses from the service providers, performing cost-benefit analysis of data, and making recommendations to the project teams on the most suitable supplier.
  • Contribute to the definition and tracking of Key Performance Indicator (KPI)/metrics and maintain up-to-date performance data.
  • Evaluation of performance of vendors with respect to quality of work, cost, communication and other related parameters.
  • Mediation and facilitation of resolution of study related issues between project owners and Suppliers.
  • Management of change in scope process, preparation of contract amendments and presentation & negotiation with vendors.

Qualifications

  • Science or Business degree
  • Strong customer focus and outstanding communication skills, written and verbal.
  • Experience of analysing financial information
  • Relevant level of experience in the pharmaceutical and/or CRO industry in a project management and/or business development capacity with a thorough understanding of (a) contract management, (b) outsourcing management
  • Study / project management within the pharmaceutical or CRO sector coupled with demonstrated business acumen.
  • Ability to work internationally and with multi-cultural teams.
  • Understanding of basic legal language advantageous but not essential

How to applyJim Gleeson - Senior Consultant at CK Clinical

Apply online now

For more information or to apply for this Clinical Operations Manager position contact Jim Gleeson on +44 (0)1438 842973 or email jgleeson@ckclinical.co.uk. Please quote reference 26783 in all correspondence. Entitlement to work in the EEA is essential.

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Novartis creates 100 jobs in Ireland

Thursday, April 11th, 2013

Pharmatimes has reported that Novartis is opening a new business services centre in Dublin creating a 100 new jobs in medical writing/communications and digital marketing.

Novartis already has a significant presence in Ireland as they employ more than 1,200 highly skilled people in its two Cork-based manufacturing plants and its commercial operations in Dublin.

The company says it conducted an extensive

study of Europe to find the best location for the centre and Dublin won out, helped by its highly-educated workforce, pharmaceutical experience and language proficiency, as well as other factors, such as accessibility and cost.

 

 Click here to see our latest jobs in medical writing

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Project Manager Study Start-Up – Home based

Thursday, April 11th, 2013

Melanie Miles is recruiting for permanent Study Start-up Clinical Project Managers for a leading international Clinical Research Organisation. This will be a home based position and available in most Eastern European Countries.

Responsibilities:

This is an exciting opportunity to project manage and lead core project team during study start up phase and facilitate team’s ability to lead extended/complete project team. Depending on size and scope of project, this job duty may be performed in collaboration with a Project Director, this varied role will include;

  • Ensuring effective cross-functional teamwork among project team members including both internal and external ancillary services.
  • Leading implementation of Six Sigma initiatives on projects as applicable.
  • Monitoring project schedule and scope to ensure both remain on track.
  • Initiating and implementing appropriate actions.
  • Accountable for budget across assigned project(s) including the control and minimizing of write-offs.
  • Proactively identifying out of scope activities and ensure necessary change orders are executed.
  • Proactively engaging in both quality assurance and risk management activities to ensure project deliverables are met according to both internal and client requirements.
  • Presenting at external and/or internal meetings.
  • Ensuring client satisfaction.
  • Supporting new staff in region and integrate them into the study process efficiently.

Qualifications:

  • A life science or nursing degree 
  • A thorough knowledge of ICH Guidelines and GCP, the clinical trial process and a basic understanding of regulatory requirements in other countries  
  • Previous relevant clinical research experience in a CRO, including at experience of full project management responsibility, especially in the study start up phase 
  • Working knowledge of financial control procedures (costing systems, time reporting)  
  • Experience of managing overseas clinical trials  
  • Broad knowledge of drug development process and client needs
  • Proven leadership skills with the ability to inspire and motivate staff within a field based environment  
  • Demonstrated Account Management and business development experience with a previous track record working as a Clinical Project Manager or in a Senior Clinical Study Start-up role would be advantageous

How to apply: 

Apply online:

For more information or to apply for this role please contact Melanie Miles on 01438 743047 or email mmiles@ckclinical.co.uk. Please quote reference CL26645 in all correspondence.

 

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Principal Programmer – Switzerland

Monday, April 8th, 2013

Mylene Paumier is recruiting for a Principal Programmer to join a global pharmaceutical company at their site based in Switzerland on a permanent basis.

Responsibilities:

As Principal Programmer, your responsibilities will include the following:

  • Coordinate programming activities across several trials, indications and small projects for multiple compounds including exploratory analysis, publication and regulatory submission activities.
  • Lead the indication/project team including resources planning and coordination of the different programming sites
  • Make certain that indication/project documents and specifications are consistent and comply with company standards by providing input into Study protocol, CRF and Data structures and outputs (listings, tables and figures) for phase I-II clinical trials and submission activities.
  • Develop programming specifications for analysis datasets, pooled datasets and deliverables in consultation with the statistician.
  • Develop and comply with project/study programming standards and specifications following internal guidelines.
  • Support quality control and quality audit of deliverables.
  • Participate as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial/project level activities.
  • Track clinical trial milestones for statistical reporting deliverables.
  • Maintain records for all assigned projects and archiving of indication/project analysis and associated documentation.
  • Maintain efficient interfaces with internal and external customers and communicate effectively across line functions.
  • Program according to specifications, analysis datasets, pooled datasets, listings, tables and figures for phase I-II clinical trials

Qualifications:

As Principal programmer, you will have the following qualifications, skills and experience:

  • Bachelor/Master’s degree in Mathematics, Statistics, Data Analysis Program or Computer Science (or equivalent degree with experience).
  • Fluent English (oral or written).
  • Ability to lead and coordinate programming work across several studies.
  • Experience using SAS in the analysis and the reporting of pharmaceutical data (early phase in Oncology therapeutic area would be desirable)
  • Working knowledge and expertise with SAS (including SAS macro language)
  • Strong analytical

    skills and the ability to think laterally

  • Working knowledge of database design/structures
  • Good understanding of global clinical trial practices, procedures and methodologies.
  • Good understanding of regulatory requirements (e.g. GCP, ICH)Mylene Paumier - European Recruitment at CK Clinical

How to apply:

Apply online:

For more information or to apply for this Principal Programmer position, please contact Mylene Paumier on +44 (0)207 470 5672 or email: mpaumier@ckclinical.co.uk.  Please quote reference CL25698 in all correspondence.

 

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Associate Drug Safety Licenser – Switzerland

Monday, March 25th, 2013

Mylene Paumier at CK Clinical is recruiting for an Associate Drug Safety Licensing to join a global pharmaceutical company at their site based in Switzerland on a 6 month contract basis.

Responsibilities

As Associate Drug Safety Licensing, you will be responsible for:

  • The Drug Safety

    Licensing (DSL) Senior Associate is responsible for writing and implementing Safety Agreements for any commercial arrangement and/or clinical studies / programs between the company and its partners as appropriate, per DSL templates, guidance’s and standard operating procedures.

  • The DSL Senior Associate will, under mentorship and coaching of a DSL manager, contribute to due diligence activities, draft, negotiate and implement the appropriate Pharmacovigilance agreements (PVAs).

Qualifications

As Associate Drug Safety Licensing you will have the following qualifications, experience:

  • Bachelor’s Degree in life science / health care degree (or equivalent through experience) with a proven experience in Pharmacovigilance
  • Proven experience in Drug Safety Licensing activities
  • Knowledge and understanding of FDA and ICH regulations and guidelines

Experience

  • Proven excellent written and verbal communication skills with an international or cross functional perspective, able to represent the company internally and externally
  • Excellent command of English
  • Knowledge and understanding of FDA, EU Pharmacovigilance Legislation and related regulatory documents, ICH guidelines and national/international GCP requirements
  • Excellent problem-solving, analytical, impact assessment and strategic thinking skills.
  • Ability to work independently, and contribute as a team member
  • Ability to simultaneously work on several projects at the same time
  • Good time management
  • Solution oriented
  • Excellent negotiation skills
  • Ability to collaborate and communicate effectively and efficiently in an international matrix environment

How to apply

CK Clinical are recruiting for an Associate Drug LicensingApply online now

For more information or to apply for this Associate Drug Safety Licensing position, please contact Mylene Paumier on 0207 470 5672 or email: mpaumier@ckclinical.co.uk  Alternatively, please click on the link below to apply online now. Please quote reference CL26531 in all correspondence. Entitlement to work in the EEA is essential.

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Global Data Manager – Belgium

Thursday, March 21st, 2013

Mylene Paumier at CK Clinical is currently recruiting for a Global Data Manager to work for a leading pharmaceutical organisation in the Belgium on a contract basis.

Responsibilities

  • Liaises continually between the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s)
  • With the trial customer, CRO and other functional partners:
  • Gathers content and integration requirements for eCRF and other data collection tools
  • Establishes conventions and quality expectations for clinical data
  • Establishes expectations for dataset content and structure
  • Sets timeline and follow-up regularly to ensure delivery of all Data Management milestones
  • Performs trial level oversight controls as described in the oversight plan, QC process and work instructions
  • Participates in User Acceptance Testing and performs trial data Quality Control.
  • Prepares or reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensures compliance with regulatory guidelines and the documentation matrix
  • Ensures real-time inspection readiness of all IDS

    deliverables for the trial

  •  Participates in Regulatory Agency and the company internal audits as necessary
  • Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverables are on time and within budget
  • Supports the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met
  • Provides input to the DML on trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate
  • Identifies and participates in process, system, and tool improvement initiatives within IDS
  • Participates in or leads non-trial/non-program projects based on specific expertise

Qualification and Skills

  • BS/BA or equivalent work experience.
  • Life sciences background a plus.
  • Experience in Clinical Drug Development within the Pharmaceutical Industry or related Industry with proven track record
  • Data Management experience required.
  • Thorough knowledge of the protocol
  • Understanding of current clinical drug development processes
  • Knowledge of applicable international guidelines regarding Data Management of clinical trials
  • Relevant System / technical knowledge
  • Knowledge and understanding of current industry standards (i.e. CDISC, SDTM , CDASH , etc.)
  • Knowledge of technology platforms for data exchange
  • Knowledge of electronic data capture (eDC) systems, preferably Medidata Rave
  • Negotiation skills
  • Key Project Management Skills
  • Effectively prioritizing and managing multiple tasks simultaneouslyMylene Paumier at CK Clinical is recruiting for a Global Data Manager in Belgium

How to apply

Apply online now

For more information or to apply for this Global Data Manager position, please contact Mylene Paumier on 0207 470 5672 or email: mpaumier@ckclinical.co.uk.  Entitlement to work in the EEA is essential. Please quote reference CL26517 in all correspondence.

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