Associate Manager Clinical Operations Manager Europe, Ref AQ1662
Primary Purpose of the Role
Celgene have recently established their International headquarters in Neuchâtel, Switzerland and are seeking to further develop clinical operations capability.
Having enjoyed tremendous success commercially and from a research perspective their pipeline is extremely healthy. As an organisation, a significant proportion of Celgene’s clinical research is outsourced. We are currently seeking to recruit clinical research professionals with the experience, vision, drive and determination to add value to these research programmes and enhance Celgene’s product development success.
The position calls for a team player with well developed clinical operations and project management experience, strong cultural awareness, confidence in your own position and able to manage internal and external resources.
Critical to success of this role, therefore, will be the ability of the selected candidate to further enhance the reputation of the European business and the value of Europe’s contribution, through both internal and external relationships.
In return, Celgene can offer the right individual a growing environment, with a positive culture where you will be able to take a highly visible role with the opportunity for personal development and growth coupled to the ability to assist in influencing, shaping and developing the clinical research expertise in line with the continued expansion of the Celgene business.
Core Responsibilities
Responsibilities will include, but are not limited to, the following:
- Plan and implement all operational aspects of clinical studies that are being performed in ROW
- Overall management of one or more clinical studies and corresponding internal/external clinical team members
- Assist in review and finalisation of protocol, CRF and clinical study report
- Organise and conduct Investigator Meetings
- Review of ongoing summary data including: safety, primary efficacy variables, laboratory data; responsible for accurate quality control and medically consistent data
- Investigator selection and site management
- Prepare and negotiate study budgets and research agreements
- Track study progress: identify and implement actions to keep projects on track
- Assist in CROs, contractor and other vendor selection as required by the team in Corporate Headquarters
- Interface with project team members including: Drug Supply, Regulatory, Data Management, Statistics, Drug Safety and Project Management
- Supervise CRAs assigned to each study, this could include CRAs from other Celgene facilities in ROW
Person Specification and Competencies
- Ability to work with complex projects
- Experience in all aspects of the drug development process
- Knowledge of GCP and ICH Guidelines
- Knowledge of Data Management processes including IT systems, e.g. Excel
- Experience working with CROs and in-house CRAs
- Multi-therapeutic area expertise, especially oncology or immunology
- Medical/scientific writing skills
- Excellent interpersonal and communication skills both orally and in writing
- Sound influencing and persuading skills
- Demonstrable track record of working within a multi disciplinary team
- Demonstrate commitment, dedication, co-operation, positive behaviour, adaptability and flexibility with changes in responsibilities and duties
Experience
- Degree in Life Sciences
- Clinical research experience, including clinical trial management
Package
- An attractive salary and benefits package will be offered, commensurate with experience, for the right candidates. This will include relocation costs, where appropriate.
- The package is negotiable, based upon the level of experience of the individual.
Click here to apply for this role
|
