Clinical Study Manager (Oncology)

Job summary
•Clinical Study Manager role in oncology
•Candidates must have previous UK start up experience
•Candidates must have oncology experience
•Working for a top 5 pharma on the M4/M40 Corridor, West London
•Freelancers welcome to apply or perm employment offered via Chiltern

Job Background
The Resourcing Solutions (RS) department of Chiltern acts in a similar way to that of a staffing solutions provider. The department is currently seeking a Clinical Study Manager to manage upto 5 UK oncology studies for our client, a world leading top 5 pharma at their offices in West London. Candidates will need to have previous oncology experience and UK start up experience to be considered. This is an office based, full-time role with no flexibility to work from home.

Job Primary Functions
•Leadership of cross functional study-teams, including CRO teams where applicable
•Setting clear study team objectives which are understood and supported by all team members
•Matrix management and motivation of the study team to maximise productivity and performance within individual studies
•Engage proactively with regional/global study colleagues to ensure performance comparisons and key learnings from other countries are implemented in UK
•Accountable for accurate MREC submissions
•Ensuring timely availability of study documentation and materials, including but not limited to IMP and all necessary approvals (including liaison with UK Regulatory Affairs)
•Preparation of study budgets and use of costing templates as appropriate
•Provide support for and where applicable drive contract and approvals negotiations with external suppliers, investigators and other parties
•Accountable for investigator selection and feasibility in conjunction with the CRS, Field Team Manager (if applicable) and Study Management Director
•Managing study specific resource requirements during the course of the study in conjunction with the Field Team Manager (if applicable) and Study Management Director
•Accountable for overall patient recruitment including contingency planning
•Track study progress against milestones at each stage of the study and ensure actions taken to deliver recruitment to target and plan
•Drive focus on data quality measures to ensure accuracy of patient data entered into e-CRFs and also data quality in other systems
•Oversee and where applicable take on the co-ordination of investigator and monitors' meetings, when required
•Ongoing management and reporting of the study budget, accruals and forecasts
•Ongoing management and reporting of study specific safety issues and safety report handling, as required (including SAE reporting)
•Review and regularly update all study databases to ensure 100% accuracy
•Work in collaboration with other stakeholders, such as Medical Advisor and brand team members in maintaining relationships with Key External Experts as appropriate.
•Maintenance and accuracy of central study files through minimum of monthly checks
•Accountable for the distribution of Clinical Study Reports as required
•If required for the UK, generation of study summaries, synopses, protocols, reports and publications through liaison with external and internal stakeholders
•Forecasting and securing IMP and non IMP supplies in conjunction with Medical Operations.

Job Qualifications
•Degree life sciences, pharmacy, pharmacology, nursing qualifications or equivalent qualification
•Experience in a similar Clinical Research role with a CRO or Pharmaceutical company
•Good knowledge of clinical research methods, SOPs and regulatory requirements
•Good communication skills, meeting chairing skills and ability to motivate others
•Organizational & planning skills, delivers to milestones
•Ability to think of novel ideas to speed recruitment, increase quality and plan contingencies
•Demonstrable ability to manage clinical trials
•Fluent English language skills essential (both written and verbal)
•Previous oncology experience essential
•Previous UK start up experience essential
•Applicants must be eligible to work in the UK

MORE INFORMATION AVAILABLE ON REQUEST
For a confidential discussion about this opportunity, please phone Peter Lewis on (0) . To apply, please send your CV to

Keywords:
pharmaceutical, pharma, contract, Clinical Trial Leader, Study Manager, CSM, Team Leader, Project Manager, PM, Study Team Leader, STL, Clinical Project Manager, CPM, Lead CRA, SCRA, Clinical research associate, office based, West London, M40 Corridor, International, ICH CGP, Lead CRA., Senior CRA, Clinical Research Associate, oncology, cancer, Breast, Lung, Leukemia, Leukaemia, Melanoma, Non-Hodgkins Lymphoma, Lung, NSCLC, ovarian, imaging, Sarcoma.

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