Clinical Trial Manager - Oss, Netherlands

Region: Noord-Brabant. Oss
Experience: Medior
Education: University
As a Clinical Trial Manager you are responsible for the day to day management of clinical trials including management of the international study team, third party vendors, clinical monitors and clinical trial sites. You coordinate and supervise all aspects of a clinical study and may take on the role of global study lead.
Your tasks and responsibilities
Manage the operational aspects of clinical trials
Manage the study project plan, including timeline, budget, and resources
Draft and/or review relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports
Contribute to development of Request For Proposals and participate in selection of CROs/vendors
Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
Train CROs, vendors, investigators, and study coordinators on study requirements
Review selection-, initiation-, monitoring- and close out visit reports
Coordinate and participate in the review of data listings
Proactively identify potential study issues/risks and recommends/implements solutions
Prepare metrics and updates for management, as assigned
Travel nationally and internationally up to 30% of the time as required
Requirements
Your competencies
Proven excellence in cross-functional, multicultural and international teams, communication, decision-making and you have outstanding organizational skills.
Demonstrated capabilities in leading specific trial related activities like planning, executing, tracking and reporting activities and demonstrated ability to meet timelines.
Thorough knowledge and understanding of FDA and EMA Regulations, ICH and GCP Guidelines.
Have ability to understand, interpret, and explain protocol requirements to others
Ability to prioritize multiple tasks
Ability to participate in interdepartmental strategic initiatives under limited supervision
You have a general, functional expertise to support SOP development and implementation
Proven flexibility and adaptability
Fluent in English
Proficient in MS Excel and MS projects
Education/ Training
BA/BS/MS in a scientific discipline
4+ years of relevant clinical experience in a CRO or pharmaceutical firm
2+ years of management experience in a clinical research environment
Experience in multiple Clinical study phases (e.g. I, II, III) and multiple stages (e.g. startup, maintenance, close out)
Experience in oncology preferred
Experience in global trials preferred
We offers you Dutch employment contract. We also offer you these benefits:
Good competitive salary;
Bachelor
2300-2800 euros gross a month
Master
2800 - 3500 euros gross a month
PhD
3500 - 3800 euros gross a month
All international candidates that start, receive an bonus of € 1800, 00 net for relocation after working one year.
Pension scheme, no waiting days are served in case of incapacity of work, accident insurance, supplementary occupational disability insurance and a collective health insurance;
Travel allowance, Holiday pay, 24 vacation days and shift allowance;
We support your relocation to the Netherlands including your working permit, provide a personal development program and introduce you into our large expat community with several social events a year.
Send your resume + diploma or certificates to or call at +359 886 832551.

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