Associate Director Clinical Study Manager
CK Group is recruiting for an Associate Director Clinical Study Manager in Oncology to join a company in the Pharmaceutical industry at their site based in Melbourn, Cambridgeshire, with the possibility of a day home working, on initially a 12 month contract basis and it pays £600-650 per day LTD.
The Company: Our client is a global pharmaceutical company with a large presence and multiple sites in the UK. They produce innovative medicines across a range of therapeutic areas to enhance the health and lives of their patients.
The Location: Located within the South East of England in Melbourn. Melbourn is a large village in the far south west of Cambridgeshire. It is located next to the A10 just north of Royston.
The Role: The Associate Director Clinical Study Manager is responsible for delivering a single or several smaller development programs or leading multiple studies. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility and autonomy is required.
Key Responsibilities include:
- Providing expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documents
- With oversight from the Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
- Leading the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards
- Accountability for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate
- Ensuring sponsor oversight throughout the life of the study
- Developing and managing effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriate
- Responsibility for planning and leading issue escalation and resolution
- Providing input to forecasting and management of study/program delivery costs, resource and timelines
- Accountability for the quality of study/program planning information into relevant planning systems
- Mentoring and supporting development of individuals within the organisation
- Contributing to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
- Responsibility for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
- Responsibility for study or program level reporting of progress, risks and issues
- Leading the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
- Provision to procurement clear specifications for study or program specific outsourcing
- Review and operational approval of study or program specific contracts or work orders
- Higher degree e.g. PhD, MSc, MPhil
- Program management qualification (e.g. MBA, PRINCE2, PMP)
- Experience in variety of academic/CRO/Sponsor organisations and countries
- Experience of early phase oncology clinical delivery
- 10 years of experience in leading studies/programs in clinical development
For more information or to apply, please contact Heather Deagle on 0191 3848905 or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47463 in all correspondence.