Reference: PW 6776
Closing Date: 28 Dec 16
Salary (£): Competitive
Benefits: Competitive Fee
Private, clinical-stage biotechnology company developing next-generation medicines for the treatment of niche therapeutic areas.
Pivotal role within the Organisation, supporting head of Clinical Development as CPM
Home based, however will need to attend meetings in London office, approximately one day a week.
Offices are based in London
International (EU) travel will be required.
6 month contract
Responsibilities for the Senior Study Manager / CPM / Clinical Project Manager include:
Manage project/operational objectives to meet timelines and deliverables; proactively track progress of assigned clinical study and identify/take appropriate actions (including remedial actions) to achieve objectives.
Act as the routine contact with clinical CRO(s), drug supply providers, regulatory consultants to ensure delivery of studies to agreed cost, quality and time.
Provide and present accurate and timely project plans and progress updates as needed.
Proactively coordinate and input to the timely review to a high standard of key study documents (including clinical, data management and statistical documents) including those required by the CROs during the course of clinical studies.
Maintain structured paper filing systems and electronic file shares relating to documents associated with the conduct of the clinical studies. Ensure essential documents including Study Oversight documents are appropriately filed and maintained (contemporaneously) in the clinical trial filing system (Trial Master File and related files).
Represent the company as Sponsor at CRO meetings, site visits, investigator meetings, competent authority meetings and other meetings as needed (this may involve some international travel).
Ensure timely reporting of SAEs, Suspected Unexpected Serious Adverse Reactions (SUSARs) and protocol deviations.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Qualifications and experience for the Study Manager / CPM role include:
A science/health care, nursing degree or equivalent.
Experience of project/operations management including multinational clinical study conduct.
A sound knowledge and experience of clinical research, regulatory standards and quality systems in the context of early stage clinical development
Preferably experience of working in clinical development within a small organization and interacting with multiple external parties would be an advantage.
Key Competencies include:
Project management experience and understanding of taking a drug through early stage clinical development
Ability to understand the scientific rationale of study designs, compound class and relevant therapeutic area
Ability to work largely autonomously and effectively as part of a small cross-functional team managing demanding deadlines and ‘stretched’ personal and corporate objectives
Ability to manage a cross-functional team mainly involving external parties, ensuring integration of inputs to enable delivery of the agreed project plan and study objectives.
Track record of risk management and generating viable solutions to address emergent issues.
Lead clinical study issue resolution.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to email@example.com quoting reference 6772.
Study Manager / Clinical Project Manager / CPM / Senior Study Manager / early phase project manager / EU Study Manager / International CPM / London / CPM / study manager / interim CPM / interim clinical project manager / contract CPM / interim study manager / EU CPM / London based CPM / London / UK COM / UK CPM / part-time
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