An excellent office based project management opportunity in Scotland, working within a World leading Global Pharmaceutical company.
Our client is a global medical device company and has been a leader in surgical sutures for more than 100 years. Today they have expanded its expertise into wound management, women’s health and cardiovascular surgery.
Headquartered in New Jersey, our client presently conducts business in 50 countries and employs approximately 9,000 employees in its various worldwide locations.
Principal duties and responsibilities will include:
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Frequent contact with inter-organisational and outside contacts with medical consultants in planning, implementing and facilitating assigned studies.
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Assisting in the planning, design, management of monitoring activities and reporting of clinical studies.
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Providing upper management with study updates.
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Assisting in the design of study budgets and financial arrangements with investigators.
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Coordinating and conducting group investigator meetings.
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Assisting in the interpretation of clinical study data.
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Being instrumental in the development of study documentation, investigator’s brochure and publication plan.
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Assisting in the development of clinical section of Regulatory submissions, as needed.
Education and/or experience required:
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Bachelor’s degree in Biological Science or nursing qualification and related scientific/technical experience (including working in a CRA or Project Manager role), or
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Masters degree in a scientific discipline and related scientific/technical experience (including working in a CRA or Project Manager role), or
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Masters degree with thesis and related scientific/technical experience (including working in a CRA or Project Manager role).
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Experience of working Phase III drug research trials.
Skills and abilities required:
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Sound working knowledge of preclinical and clinical research, familiar with requirements and current attitudes of regulatory agencies and have technical writing capability.
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Worked on a wide variety of problems relating to clinical studies, such as protocols, resolving problems with progress of investigators, grant applications and remuneration.
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Be extremely flexible and able to change priorities rapidly.
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Be computer literate (Microsoft Windows, Word, Excel, Power Point)
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GCP, CFR, ICH and ISO knowledge required
Please contact Novella Clinical Resourcing on 01438 221122 or via ksnook@novallaclinical.com for more details.
