CK Clinical

Contract Statistician- Excellent Rates

A reputable Pharmaceutical company has an urgent requirement for an experienced Statistician to join them for a 3-4 month contract.

In this role you will be working in a small team of Statistical Programmers and Statisticians, working on 2 end^studies. Here you will work alongside a statistical programmer to create figures, tables and listings of clinical trial data.

To be successful in this role you will have experience of working in a pharmaceutical company or CRO in a similar role.

Pharmacovigilance Manager - Global

The objective of your role as Pharmacovigilance Manager will be to:

Provide strategic advice for the management of global Pharmacovigilance (PV) and ensure that the appropriate PV and risk management systems are in place to comply withglobal regulatory requirements and that the department is inspection-ready. Manage PV staff. Represent the company on industry teams both locally and internationally and develop and maintain strong working relationships with relevant internal and external stakeholders.

Your duties will include:

Management

- Support departmental strategic planning by providing PV advice on budgets and resource plans.

- Recommend, develop and ensure implementation of PV strategies to meet business objectives.

- Develop in-depth knowledge of PV processes in all relevant countries, providing a global overview and expertise within the company.

- Manage selection and implementation of outsourced support (e.g. PV consultants), including development, negotiation and amendment of associated contracts.

- Proactively identify issues and propose solutions for areas requiring improvement.

- Initiate and maintain high-level relationships with relevant stakeholders (e.g. key regulatory agency staff, peak industry bodies, professional societies and associations).

- Manage/participate in multidisciplinary project teams.

- Develop an overall perspective of PV projects and supervise team members.

- Manage the staffing, resources and budget planning, and tracking for the PV team.

- Oversee the performance management, professional and personal development of line reports.

- Create an open environment, which encourages team and individual growth.

Adverse events and safety reporting; signal detection and evaluation

- Ensure processes are in place for the collection, evaluation, documentation and reporting (where appropriate) of all adverse events associatedwith all company products arising from global clinical trials, pre-authorisation named patient supply and post-marketing supply.

- Oversee the preparation and submission of global Periodic Safety Update Reports (PSURs) and clinical safety reports, ensuring accuracy of scientific content and compliance with regulatory timelines.

- Ensure searches of the worldwide scientific literature for safety on all company products are conducted on a regular basis.

- Be an active member of theDrug Safety Committee, responsible for safety signal detection, evaluation and monitoring.

- Manage response formulation to urgent (and other) safety information requests from regulatory authorities or other parties.

- Participate in product^recalls for safety reasons in conjunction with other relevant company personnel.

- Provide safety input into study protocols and Investigator brochures.

PV compliance

- Manage PV compliance and quality assurance of PV processes. Determine requirements for new/revised SOPs and procedural documents and write/review PV SOPs. Have a high level understanding of company procedures.

- Ensure adequate and timely training of company personnel in adverse event reportingresponsibilities.

- Oversee the development, negotiation and amendment of safety contractual agreements (eg. as part of Distribution Agreements).

- Manage the preparation and conduct of regulatory inspections and internal audits.

Travel Requirements

- National and international travel may be required, 2-3 times a year.

Essential Skills and Competencies

- Pharmacy or medical degree preferred. Postgraduate qualifications in a relevant pharmaceuticalindustry discipline desirable.

- Strong experience in the pharmaceutical industry, specifically in the Pharmacovigilance field.

- Current experience in international pharmacovigilance, with experience working in Europe and/or the United States.

- In-depth knowledge of applicable global regulations, guidelines and policies.

- Prior line management experience and demonstrated leadership skills.

- Ability to innovatively search for solutions to complex technical and procedural problems.

- Strong interpersonal, communication and negotiation skills, written and verbal, internal and external; demonstrated medical writing skills.

- Excellent organisational and planning skills; high attention to detail.

- Able to prioritise, multi-task and meet deadlines.

- Able to work independently and as a team member.

- Computer proficiency (Microsoft Office, databases).

Line Management

The position reports into the Regulatory Affairs Manager.

If you would like to know more about the role please call Hendre at 01438 743 047. Alternatively make us aware of your interest in the position by sending your CV to hmoolman@ckclinical.co.uk, quoting the reference number.

Clinical Project Manager
Clinical Project Manager Marlow £40K possibly higher dependent on individual No- At least 2yrs experience as CPM for a pharma or CRO managing clinical trials in Phase II or III - International CPM experience, where the candidate has managed teams including members outside UK eg- EU, ROW or US - Project management - Therapeutic experience in rheumatoid arthritis, Oncology, phase I would be ideal but not essential. - Ability to directly manager CRAs in teams without the need for linemanagement. - Budget management Ability to work in UK essential

Outsourcing & Contracts Manager
Outsourcing & Contracts Manager 6 month contract Slough Daily rates dependent on individuals experience Position to start ASAP A 6 month contract role for an experienced person (ideally with a strong operational background with demonstrableexperience in outsourcing). In this role you will ensure that the identification, selection, negotiation and purchasing of all clinical contracts with external suppliers are managed to the most rigorous standards of quality, timely deliver and within budget in support of the achievement of Clinical Development objectives and to achieve clinical excellence. Ability to "hit the ground running" as this is a short term contract position. Ideally based in the Slough office (although would also consider an individual based in Paris ), with travel to French offices (or UK offices if based in France). Ability to work in UK essential

Clinical Research Manager
Clinical Research Manager (12 month contract) A unique opportunity has arisen to join innovative European Pharmaceutical group with over 20 products on the market and over 4000 employees worldwide. In this position you will plan, prioritise, co-ordinate and project manage (as required), all clinical trial activities (phases II to IV, Post Authorisation Safety Studies (PASS) and Externally Sponsored Studies (ESS)) performed by the UK Medical department within the frameworkof global SOPs and^ICH/GCP. Responsibilities will also include: · To provide advice and support to investigators on the design and conduct of ESS of UK licensed products. · To take line management responsibility for other clinical trials staff within the UK Medical department. · To manage the overall clinical trials activities of the department, including resource planning and allocation, prioritisation of workload and provision of guidance and support to reportees. Experience Required: · A minimum of 5 years relevant pharmaceutical drug development experience including project management of national and international programmes. · Detailed knowledge of Good Clinical Practice (GCP) and other applicable regulations governingclinical research. · Experience of working with multi-disciplinary groups. · Experience of managing and developing relationships with Contract Research Organisations (CROs) and / or other contractors. · Experience of compiling and managing project budgets. · Experience of line management. · Experience of writing / reviewing SOPs. Ability to work in the EU is essential

Project Manager
Our client is a world leading clinical contract research organisation. We are currently seeking an experienced project manager to take overall responsibility for the coordination and management set up, conduct, tracking, and quality and regulatory compliance of projects allocated to them. These may be conducted nationally or internationally. May also assist with preparation and presentation of marketing proposals. Oversee training of project specific training. Eligibility to work in the EEAis required.

Medical Information Officer

An opportunity has arisen for a Life Sciences or Pharmacy Graduate to join the Medical Information Team, in the position of Medical Information Officer. Working with the full, diverse range of products and a variety of teams from across the company, the position will appeal to an Associate who is keen to broaden their experience and build upon their current knowledge of the Pharmaceutical business, in a varied and challenging customer service role.
The position would appeal to someone with excellent communication skills, both written and verbal, and a lively interest in learning more about the company's products and information retrieval systems.
The role will involve:
- Providing a comprehensive medical/technical enquiry service to all users of the company's products through the retrieval, evaluation and presentation of high quality information using in-house and external information sources.
- Providing information support services to meet the needs of the business teams, field-based staff and other in-house personnel.
- Recording adverse drug reaction and suspected defect report data and liaising with customers and other in-house personnel to ensure that the appropriate^responses to meet statutory and Duty of Care obligations are met by the company.
- Supporting customer facing teams (e.g. field-force, MDAs) with client contacts allowing for optimisation of relationship building opportunities.
Thesuccessful candidate will need to demonstrate the following skills and capabilities :
- Ideally some experience of providing information and technical support within the pharmaceutical industry or a hospital environment.
- Excellent communication skills both written and verbal.
- Good PC skills, including knowledge of text retrieval systems and effective use of the internet.
- Attention to detail.
- An ability to work as part of a team, as well as demonstrating anability to manage and prioritise your own workload in a busy environment.
If you would like to know more about the role please call Hendre at 01438 743 047. Alternatively make us aware of your interest in the position by sending your CV tohmoolman@ckclinical.co.uk, quoting the reference number 16358 in your email. If you want us to help you with other jobs do not hesitate to give Hendre a call on 01438 743047.

Pharmacovigilance Scientist - 6 Month Contract

We are recruiting for a Pharmacovigilance Scientist to work within the UK affiliate Pharmacovigilance team, liaising with members of the Medical division, other company departments and externally with the MHRA and IMB to provide compliant Adverse Event Reports (AERs).
Your key accountabilities will be:
- To provide timely and compliant handling of adverse event cases to GSSEL and regulatory authorities.
- To provide and review safety information to/for relevant parties e.g. Medical advisors.
- To liase as appropriate with the MHRA and IMB following company SOPs as required.
- To maintain compliance with company policies including monitoring of internal and regulatory timelines for case processing.
Your responsibilities will include:
- Assessment and processing of adverse events received from all sources within the UK and Ireland, utilising the relevant safety database.
- Submission of adverse event reports as applicable to GSSE headquarters, ethics committees and appropriate regulatory authorities, within the required timelines.
- The assessment and submission of worldwide cases received from GSSE and/or business partners to the relevant regulatory authority ensuring compliance with the required timelines.
Skills required for the position
- Knowledge of general software applications eg.MS Word, MS Excel
- Knowledge of pharmaceutical legislation relevant to role, local Medical division procedures and documentation, GSSE procedures and documentation
- Attention to detail/self-starter
Qualification and Experience
- Life sciences degree or professional qualification eg, pharmacist, registered nurse
- Preferably experience of Drug safety or at experience in an appropriate healthcare or industry position e.g.regulatory affairs.
- Excellent understanding and working knowledge of medical terminology
If you would like to know more^about the role please call Hendre at 01438 743 047. Alternatively make us aware of your interest in the position by sending your CV to hmoolman@ckclinical.co.uk, quoting the reference number 16351 in your email. If you want us to help you with other jobs do not hesitate to give Hendre a call on 01438 743047.

Drug Safety Scientist - Contract

As a Drug Safety Scientist, you will assist in the daily operation of the Drug Safety Department in the collection, evaluation and reporting of Safety Information from clinical trials and spontaneous sources. You will have key working relationships with the Medical Affairs Physicians, Medical Information Services and Global Drug Safety.
Your main responsibilities as Drug Safety Scientist will involve:
- Handling serious adverse events and pregnancy reports in accordance with Drug Safety working practices, including triage assessments, entering cases into the global Drug Safety database, reviewing and evaluating cases and reporting to Regulatory Authorities.
- Understanding and complying with Clinical Drug Safety procedure and Adverse Event reporting.
- Up to date knowledge of regulatory requirements for expediting reports from clinical trials and other spontaneous sources.
- Assisting with safety and serious adverse event data collation for internal and external use.
Your skills and qualifications will ideally include:
- Science based degree or equivalent and / or
- Previous experience in drug safety
What the client is looking for:
You will be highly professional and enthusiastic about working in Drug Safety. This is an ideal opportunity for someone looking to build a career in Drug Safety.
If you would like to know more about the role please call Hendre at 01438 743^047. Alternatively make us aware of your interest in the position by sending your CV to hmoolman@ckclinical.co.uk, quoting the reference number 16353 in your email. If you want us to help you with other jobs do not hesitate to give Hendre acall on 01438 743047.

Drug Safety Manager (UK And Ireland)

Your responsibilities as Drug Safety Manager will include:
- Ensuring the company complies with all the relevant legal requirements concerning drug and medical device safety and the requirements of Global Drug Safety.
- Liaising and^negotiating with the regulatory to ensure that the company's objectives are met satisfactorily and that pharmacovigilance surveillance, devices vigilance and reporting are carried out in line with regulatory requirements and guidelines.
- Educate staff regarding the regulatory requirements for medicines and devices, with particular respect to the company's, and their individual drug safety/devices vigilance responsibilities.
- Producing and maintaining the relevant local procedural documents for pharmacovigilance and device vigilance, including the Pharmacovigilance Manual, as they relate to the company's activities and responsibilities within Global Drug Safety.
- Liaising proactively with the Medical Director to ensure that an effective risk management system is in place.
- Liaising with associate companies, licensors and business partners to obtain the necessary information to comply with our drug and medical device safety obligations
-This function sits atthe first and last stages of almost all pharmacovigilance activities and thus ensures that the whole local company organisation is contributing to the global risk management responsibility of the company.
- Providing drug safety advice on the development and marketing of medicines, including post-authorisation studies, and medical devices.
- Ensuring that relevant agreements are in place with contractual partners to ensure that the company can fulfil its drug and device vigilance obligations.
- Maintaining an awareness of the changing environment in pharmacovigilance, particularly with respect to changes in local legislation, and transmitting relevant information to Global Drug Safety.
- Notifying Global Drug Safety of any clinical safety issues which have the potential to create public interest or involve legal action or liabilities.
- To provide line management support for the Drug Safety Officer to include development, training support, appraisals etc
-^To comply with all UK regulatory guidelines and company SOPs in relation to the 2006 ABPI Code of Practice, MHRA and all other authorities related to your functional position
KEY INTERNAL RELATIONSHIPS
- Drug Safety Team colleagues
- Medical Director
- Medical Team colleagues
- Regulatory Team colleagues
- Training Manager
- Global Clinical Development
- Global Drug Safety
If you would like to know more about the role please call Hendre at 01438 743 047. Alternatively make us aware of your interest in the position by sending your CV to hmoolman@ckclinical.co.uk, quoting the reference number 16352 in your email. If you want us to help you with other jobs do not hesitate to give Hendre a call on 01438 743047.