ArrayDiagnostica the CRO insourcing company

2 International Study Managers (ISM) at ArrayDiagnostica

ArrayDiagnostica is increasing its Swedish appearance and is looking for 2 International Study Managers, working in the Stockholm area. Corporate language is English. The ISM will be working as consultant in a large Pharma organisation in minimum 2-3 years.

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.

Qualifications (minimum requirements):

" Broad knowledge of clinical trial methodology

" Fluent in written and spoken English

" Team oriented personality with high degree of flexibility and cross-cultural awareness

" Understanding of project management

" Good presentation, communication and negotiation skills

" Ability and willingness to adjust quickly to new situations in a continuously developing environment.

Professional experience:

Preferably experience in planning and conducting clinical trials

Preferably experience from working in a project oriented, international matrix organization

Key areas of responsibility:

The International Study Manager (ISM) is the global project manager for a single clinical trial being responsible for international coordination of study activities (phase 2 and onwards) carried out in accordance with the Clinical Development Plan (CDP)/Project Business Plan (PBP). The ISM is the team leader for the International Study Group (ISG) with team members from other functional areas involved in the clinical trial e.g. data management, Sponsors affiliates etc.

The ISM drives the progress of trial activities, and delivers results that have a direct impact on the successful conduct of the clinical trial i.e. key deliverables at the BSC. The ISM responsibilities may include, by contribution or completion depending on skills and experience:

" Planning and co-ordination of clinical trial activities including trial protocol preparation in accordance with the CDP/PBP.

" Input to project related documents (e.g. CDP, PBP, and Investigators' Brochure), if appropriate

" Input to study related documents (e.g. CRF, Trial Validation Plan, Statistical Analysis Plan)

" Clinical trial budgets incl. follow-up on external clinical trial costs

" Ensure study related CRO contract negotiation and maintenance of contracts

" Input to high-level clinical documents for submission of new drug applications worldwide

" Providing operational and therapeutic expertise to the project, trial protocols, clinical trial reports and scientific papers

" Survey and reporting on trial progress including study recruitment, monitoring activities, data quality and compliance with Sponsors Procedures

" Plan, conduct and chair the International Study Group (ISG) meetings.

" Participate in and contribute to Investigator and Monitor meetings.

" Presentation of the clinical trial protocols and results internally and externally in collaboration with the IMO

" Ensure that the Director Clinical Operations is kept up to date on trial progress

" Give input to monthly reports and status reports on the designated project(s)

" Review trials for LTR on request

" Participate in working groups within Global Development as well as cross functional groups

Main job tasks:

1. Trial Protocols:

" Prepares study protocols, amendments, master patient information and informed consent forms in accordance with synopsis and approved CDPs/PBPs, the policies and procedures of Sponsor and in agreement with clinical trial SOPs

" Prepares monitoring guidelines, coding manuals for concomitant illness and concomitant medication, and provides input to the CRFs

" Prepares the budget for external trial costs and follow up

" Negotiates contracts with CROs in accordance with 'Assignment of Tasks and Responsibilities for Clinical Trials (phase 2-3b) procedure

" Coordinates the study group through the protocol preparation, trial execution and the reporting phase which includes responsibility for ensuring updating of Gantt charts or similar

2. Trial Execution:

" Co-ordinates trial related activities across all involved departments/regions/countries

" Prepares International Study Group Meetings and Monitor/investigator Meetings

" Prepare Global Recruitment Strategies and ensure preparation of Country and Site Strategies

" Surveys study progress with proper proactive corrective actions

" Prepares specifications and ensures selection, negotiation and supervision of central laboratories and other CROs undertaking clinical trial related activities in collaboration with the Outsourcing Manager

" Supports Investigator Meetings, monitoring activities and organizes study and project specific training upon request

" Reviews trial validation plans and statistical analysis plans

" Archives relevant documents in TMF and SponsorDocs

3. Trial Reporting:

" Coordinates or contributes to multinational results meetings on request

" Contributes to report review, internal results presentation and publication preparation

Application:

Please send your application and CV to info@arraydiagnostica.com.

If you need further information about the positions please contact - Thomas Vorre at: phone +45 56508812 or +4658550511.