As a Epidemiology Research Assistant you will provide support to a range of epidemiological projects to increase disease understanding related to drug development and clinical trials, such as incidence, risk factors, co-morbidities, phenotypes and biomarkers.
The successful candidate will have an MSc in Epidemiology and hands-on experience conducting or supporting epidemiological research.
For more information or to apply for this Epidemiology Research Assistant role please contact Jim Gleeson on 01438 743 047 or email email@example.com. Please quote reference CL25999 in all correspondence.
Posted in Featured Jobs
p>Shreeya Patel at CK Clinical is recruiting a Clinical Trial Regulatory Lead to join a global pharmaceutical company at their site based in the South East on a 6 month contract.
As Clinical Trial Regulatory Lead you will be responsible for managing and assisting in all regulatory aspects for Phase 1 – Phase 4 clinical trial authorization applications conducted globally, regionally or locally, spanning all relevant Therapeutic Areas.
Main responsibilities will be:
- Attend/Lead CTA meetings to prepare/compile CTA applications for submission to global Health Authorities.
- Prepare EudraCT forms.
- Create/maintain/update CTA content plans.
- Prepare the list of ongoing trials using available template.
- Follow-up with Core document owners on status of documents needed for the CTA packages.
- Interface with publishing/production on publishing/dispatch/submission of CTAs from CTA content plans.
- Import documents into GRIPS/ERIS for direct filings.
- Maintain/Update CTA approval status.
- Regulatory CTA Experience is essential for this role
- Previous experience of working with pharmaceutical organisations required.
- The successful candidate will ideally be educated to degree level
The individual must be proactive and able to work independently requiring minimal supervision
How to apply
Apply online now
For more information or to apply for the role, please contact Shreeya Patel on 01438 743047 or email firstname.lastname@example.org. Please quote reference CL25763 in
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Posted in Featured Jobs
Mylene Paumier at CK Clinical is recruiting for a Senior Statistician to join a global pharmaceutical company at their site based in Switzerland on a permanent basis.
As Senior Statistician, your responsibilities will include
- All statistical tasks of individual clinical trials.
- All statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence e.g.: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase.
- May be assigned to lead a small project or parts (e.g. indication) of a project, initially under the guidance of a more experienced statistician, but with increasing autonomy and accountability.
- Track clinical trial/allocated project activities and milestones.
- Ensure timeliness and adequate quality for the assigned trials and project tasks.
- Participate in or lead non-clinical project activities as needed.
- Establish and maintain sound working relationships and
As Senior Statistician, you will have the following qualifications, skills and experience:
- At least Masters Degree in Statistics (or equivalent degree) with experience or PhD with experience.
- Fluent English (oral or written).
- Experience in all tasks of a Trial Statistician.
- Proven knowledge in Statistics and its applications to clinical trials. Proven knowledge of drug development and HA guidelines.
- Background medical knowledge, preferably in relation to the specific therapeutic area.
- Proven knowledge of statistical software packages.
- Good communication and presentation skills. Good team player
How to apply
Apply online now
For more information or to apply for this Senior Statistician position, please contact Mylene Paumier on +44 (0)207 470 5672 or email: email@example.com. Alternatively, please click on the link below to apply online now. Please quote reference CL25702 in all correspondence.
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Posted in Industry News, News
Hendre Moolman at CK Clinical is recruiting for a PV Process Excellence Coordinator to join a company in the pharmaceutical industry in a fixed term contract role in the South East.
As a PV Process Excellence Coordinator you will be responsible for working across the PV team to understand and refine the processes to drive efficiencies and consistency. You will be working with the Head of PV Operations, existing members of the team, global PV colleagues, and colleagues in other departments, to help improve daily processes.
Further responsibilities of PV Process Excellence Coordinator position will include:
- Leading matrix teams within the local PV team, to help bring consistency in working practice and to strengthen overall PV operations
- Playing a leading role in the creation of streamlined processes both within the team and in a cross functional and global setting
- Being responsible for the development and driving better ways of working and also project managing some important process improvement initiative while playing a key role in the training and implementation of these
- Being involved in the creation and maintenance of appropriate SOPs and WPs
- Facilitating the implementation of some aspects of the new PV legislation
- Working together with Head of PV Operations to help strengthen and streamline operations, including any process improvements to create a highly effective and compliant operation.
- Coordinating cross departmental process improvement activities to strengthen PV working with colleagues.
- Playing a key role in leading PV operational projects including facilitating complex discussions in matrix teams to successful outcome.
- Undertaking other activities and projects as required by line manager and to help ensure high quality documentation, guidance and training are in place.
- Collaborating with other members of the department, including global colleagues and working in collaboration with the PV ICSR manager and PV Scientific Manager as required
- Interacting with colleagues in clinical, clinical operations or regulatory and possibly IT
As PV Process Excellence Coordinator you will have the following qualifications, skills and experience:
- Science Degree (e.g. pharmacy, Nursing, Life Science).
- Proven experience in pharmacovigilance including case handling, aggregate reports, other PV deliverables
- Experience of coordinating project improvement initiatives and in leading matrix teams to a successful outcomes, including at a global level.
- Extensive knowledge of global PV regulatory legislation (both pre and post marketing) including the new EU legislation
- Strong understanding of PV business, in a global setting.
- Proven ability in project delivery, including writing working practices and SOPs, training and implementation of new processes
- Demonstrated experience of leading process improvement initiatives
- Possessing a strong sense of responsibility and having a good track record of working to strict deadlines
- Excellent organisation, coordination or project management skills
- Good communication and facilitation skills
- A quick thinking decision maker and problem solver
- Leadership and drive – in pursuit of operational excellence
- Proven ability to identify streamlining opportunities and to take projects forward.
- Excellent negotiation skills -with an ability to reach consensus despite disparate views
- A creative thinker with a sense of urgency
- Ability to work consistently and autonomously, seeking advice where necessary
- Able to form strong cross-departmental and cross-functional relationships
As a PV Process Excellence Coordinator you will be joining a global pharmaceutical company based in the South East.
- You will be working with a global company
- You will have a competitive salary
- 2 year fixed term contract role
Please contact Hendre for more details.
How to apply:
For more information or to apply for this PV Process Excellence Coordinator position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org. Please quote reference CL25881 in all correspondence.
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Posted in Industry News, News
Jim Gleeson at CK Clinical is recruiting for permanent Study Start-up Clinical Project Managers for a leading international Clinical Research Organisation. These will be home based positions and available in most European countries.
This Project Manager Study Start-up 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.
Skills and experience:
To be considered for this Project Manager Study Start-up job this ideal candidate will have the following skills and 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 pharmaceutical company/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:
If you would like to find out more or apply for this Project Manager Study Start-up job please contact Jim Gleeson on 01438 743 047 or email email@example.com. Please quote reference CL25848 in all correspondence.
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