CRO Specialist
Vector B2B - Drug Development
Lisboa, PT
há 2 horas
source : Ofertas de Emprego

Essential Duties and Responsibilities include, but are not limited to, the following :

Interaction with main stakeholders (authorities, clients, vendors, etc., as applicable)

Ensure effective budget management

Ensure deliverables are met according to the plan in alignment with all the applicable SOPs and regulatory requirements

Identification of areas of improvement with action plan implementation

Ensure appropriate training to the team (legislation, guidelines, technical training, etc.)

Ensure compliance with ICH / GCP standards and internal / external procedures

Ensure development and implementation of quality control

Responsible for the overall coordination and management of clinical trials from start up through close out activities

Primary source of communication of all project stakeholders, including clients, regarding all project matters, including discussion and definition of milestones and deadlines

Recording and sharing interactions with client and acting as their representative

Gathering and examining trial documents

Identification and development of collaborations with service providers (academic or others), other important customers and stakeholders, including professional organizations that can offer or acquire services in clinical research

Basic Qualifications :

Degree in Health or Life Sciences

10 years minimum work experience in a CRO, including relevant clinical operations experience, project management, and a leadership role

Knowledgeable about all the areas involved in clinical studies set up and conduct (e.g. medical writing, data management, clinical supply, monitoring, pharmacovigilance, etc.

Experience in one or some of these areas is a plus.

Experience with site audits and inspections

Knowledgeable about applicable local and international clinical research legislation and guidelines and regulatory processes

Experience with budget planning and control

Write, review, manage and QC documents for CRO clients, meeting scientific and regulatory standards as applicable

Data quality assessment, interpretation analysis and presentation

Preferred Qualifications :

GCP certificate

Experience in regulatory and submission to corresponding authorities

Effective leadership skills and proven ability to foster team productivity and cohesiveness

Good interpersonal, communication and presentation skills

Positive attitude

Problem solving capacity and result oriented approach

Strong time management, organizational & planning capacity

Good computer skills

Solid English knowledge, both written and spoken

Availability to travel as needed

Please send CV to

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