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Pharmaceutical - International Clinical Project Manager Jobs - Berkshire

Pharmaceutical - International Clinical Project Manager Jobs - Berkshire (Job Ref: WR/JOBS/22732-9160)

Job Description :

Flame Pharma Pharmaceutical - International Clinical Project Manager Job - Berkshire:

An excellent opportunity has arisen to become Clinical Project Manager for one of the world’s leading pharmaceutical organisations.  Reporting to the Head of Therapeutic Division (Diabetes) and/or International Project Director, the International Project Manager is responsible for the initial conception of clinical trials within the relevant therapeutic area and subsequently to provide medical management of these clinical trials in Phase I, II or III and post registration.  This role would suit a clinical/medical professional with extensive experience within clinical research or the pharmaceutical industry.

Job Title

International Clinical Project Manager

Background

Due to expansion, our client is recruiting an International Clinical Project Manager.  Reporting to the Head of Therapeutic Division (Diabetes) and/or International Project Director, the International Project Manager is responsible for the initial conception of clinical trials within the relevant therapeutic area and subsequently to provide medical management of these clinical trials in Phase I, II or III and post registration.  This role would suit a clinical/medical professional with extensive experience within clinical research or the pharmaceutical industry.

Key Responsibilities

• To contribute to the design of the global clinical development plan.
• Prepare the scientific rationale for a clinical study including regulatory affairs documents and seek feedback from opinion leaders regarding the feasibility of the study.
• Remain up to date and informed regarding regulatory, scientific and clinical information for respective therapeutic area through attending conferences, relevant literature and general awareness,
• To propose relevant and known experts and opinion leaders to undertake clinical studies.
• Discuss the protocols of the clinical studies with experts and opinion leaders.
• To participate in the choice of co-ordinator and investigators within affiliates and CROs where appropriate.
• To write and update the clinical aspect of the Investigator Brochures
• To create and write the International Technical Protocols and design the primary and secondary parameters.
• Write and validate the International version of the patient information sheet and informed consent document and other documents for patients
• To validate the medical aspects of Case Report Forms (CRFs).
• To estimate the budgets relating to clinical trials and possible amendments/deviations and re-evaluate these as necessary.
• Validate and regularly re-evaluate the deadlines for the study set-up, follow up and termination.
• To organise the creation of different committees (steering, scientific, safety) and liaise with the experts involved in these committees.
• To write synopses and documents concerning the country and investigator feasibility assessment for the CROs.
• To train all partners (Clinical Project Manager, CRAs etc) on relevant study documentation and pathology.
• To organise and chair the monitors’ and clinical project managers’ meeting.
• To prepare the medical section of the monitoring guide and medical review guide.
• Participate at investigator meetings playing an essential role in the communications strategy relating to the product.
• To review what should be considered as an alert value for a specific study in conjunction with the central laboratory and experts.
• To ensure that presentations on product and protocol for pre-study investigator visits are prepared and updated as required.

 Experience and Qualifications

• MBChB
• Specialist in the diabetes therapeutic area
• Familiarity with Good Clinical Practice, clinical trial methodology, terminology and procedures.
• Extensive experience within clinical research (either CRO or preferably Pharmaceutical company)

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a very competitive salary.

Key Words

Diabetes, Clinical Project Manager, Clinical Project Management, Senior Manager, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

The position will be based in Berkshire