ArrayDiagnostica the CRO insourcing company

International Study Managers at ArrayDiagnostica

ArrayDiagnostica is increasing its UK appearance and is looking for 3 International Study Managers, working in the London area. Corporate language is English. The ISM will be working as consultant in a large Pharma organization as permanently or temporally employed by ArrayDiagnostica.

ArrayDiagnostica offers:

ArrayDiagnostica is, opposed to most other global CRO's, integrating our staff as partners. You will have access to at least 10% of the company's profit for training, and professional and personal development. We call our philosophy Substantial Management opposed to Lean Management.

PURPOSE OF THE JOB:

To plan and manage international clinical studies in phase II-IV according to ICH-GCP, current SOPs and working instructions. To implement a large E-clinical operation within all clinical studies at sponsor as well as in global affiliates.

RESPONSIBILITIES:

" Management of the study from protocol synopsis to closure of study

" Lead the Study Management Team

" Responsible for timelines and ICR part of the study budget

" Address quality issues as they are identified

" Primary contact person to coordinating investigator after final protocol synopsis

" Primary contact person on the study

" Implement E-clinical in the organisation

" Being a pert of the E-clinical development and implementation task force/team.

TASKS:

" Participate in the development of the protocol synopsis

" Write the protocol, including amendments if applicable, based on protocol synopsis, and with input from relevant study management team members

" Write patient information sheet and informed consent

" Coordinate feasibility survey if applicable

" Collaborate with CTS in early planning of IMP supplies

" Monitor recruitment and establish action plans in close collaboration with the medical directors

" Arrange, chair and speak at investigator meetings

" Train, supervise and support the CRAs and relevant affiliate personnel in the protocol, compound and study specific procedures

" Ensure preparation and distribution of study specific documents and material

" Liase with sponsors Legal Department regarding agreements, insurances etc.

" Liase with Regulatory Affairs regarding Clinical Trial Applications

" Review and approve the CRF

" Prepare the monitoring manual

" Coordinate CRA resources with CRA Managers

" Responsible for the outsourcing in collaboration with the affiliates, relevant departments and the sponsors contracts manager

" Responsible for contracts with external providers e.g. central laboratory, in collaboration with the sponsors contracts manager

" Perform co-visits with the CRAs to ensure compliance with protocol and study specific procedures when relevant

" Answer study specific questions from investigators, CRAs and Ethics Committees

" Maintain overview of SAEs reported

" Review and approve note-to-files

" Ensure close collaboration with the CRS / CRP / medical expert

" Provide information to coordinating investigators, investigators, CRAs, study management team members and other relevant personnel

" Inform the clinical core team member, the Clinical Project Coordinator, the line manager, the section leader in Clinical operations of the progress of the study when required

" Act as eRoom coordinator for the study

" Respond to audit reports in cooperation with the CRA, CRA Manager and other relevant parties

" Participate in inspections on the study

" Update study budget at least quarterly

" Participate in blinded data review meeting

" Participate in soft-lock of database

" Support the medical writer in the reporting phase

APPLICATION:

Please send your application and CV toClient Service Director Susan Buus Jensen at Susan.buus.jensen@arraydiagnostica.com.

If you need further information about the positions please contact - Susan Buus Jensen at: Phone: +4520557785