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Job Details

PW 6776 Interim Clinical Project Manager

Company: AXESS
Location: London
Reference: PW 6776
Closing Date: 28 Dec 16
Type: Contract
Salary (£): Competitive
Benefits: Competitive Fee

Job Summary:

Opportunity for an experienced Clinical Project Manager to join this exciting niche organisation as a pivotal member of their clinical team. Remit includes phase II project management, UK and EU and will require exceptional vendor management skills and experience. Offered on a six month basis, home based with meetings in the London office and ideally part-time three or four days a week.

Requirements:

BACKGROUND

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

 

PRIMARY DUTIES

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

Leadership:

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.

 

TO APPLY:

For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference 6772.

 

KEYWORDS:

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

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.axess.co.uk

 

Apply for this job:  PW 6776 Interim Clinical Project Manager

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Surrey
TW9 1AA
England
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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