Clinical Project Manager

Location
Berkshire
Salary
Dependent on experience
Posted
07 Sep 2017
Closes
05 Oct 2017
Ref
J4192
Contact
Eve Hegarty
Contract Type
Permanent
Hours
Full Time
We are currently working exclusively with a growing, well established pharmaceutical firm in their search for a Clinical Project Manager to join their facility based in the Berkshire area. As the Clinical Project Manager you will be responsible for delivery of assigned clinical projects according to the approved timeline and budget, and to acceptable quality in line with regulations, standard operating procedures and Good Clinical Practice guidelines

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Clinical Project Manager will see you create and execute trial level project management plan for assigned studies:

1. Risk assessment and risk management plan, critical path and key milestones for project timeline development (e.g. Gantt chart).

2. Regulatory and Ethics submission/approval/reporting plan and core document development

3. Budget oversight: projected and actual spend for each vendor, including invoice approval and reconciliation. Quality plan including master audit schedule. Manages contracts and consultant agreements with external parties and organisations, as appropriate.

4. Site selection and subject enrolment strategy. Forecast clinical supplies including study drug. Ensure all vendors are equipped with required documents, plans and materials to enable them to meet project requirements. Manages all clinical trial vendors (e.g. IVRS, central labs, study depot).

5. Reports overall trial timeline and progress to internal stakeholders and gains alignment with cross-functional team members on milestone dates.

6. Manages internal and external relationships and serves as point of communication at the trial level

A full job description can be provided upon application.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Clinical Project Manager we are looking to identify the following on your profile and past history:

1. Relevant degree or higher in a life sciences based discipline, plus extensive experience working on relevant clinical trial projects, and proven success in the management of multi-national clinical trials. Therapeutic experience in CNS is preferred (Parkinson's Disease especially preferred).

2. Proven experience of scientific methods and research design across phases I - III. Thorough understanding of ICH Good Clinical Practice guidelines, clinical trials management, regulatory compliance (including UK statutory instruments).

Key Words: Clinical Project Manager | Clinical Research | Clinical Trials | Pharmaceuticals | CNS | Parkinsons Disease | ICH | Clinical Trials Management

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.

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