Senior Clinical Research Manager

2 semanas atrás


Lisboa, Lisboa, Portugal Michael Page Tempo inteiro
Sobre o nosso cliente

Our client is a pharmaceutical company with experience in various therapeutic areas.

Descrição

- Plan, implement, evaluate, and complete full execution of studies by setting goals and timelines

- Monitor ongoing resource needs to the projects, assuring SOPs and Project Management tools will be in place

- Provide monthly project status reports. Evaluate and manage project budget against project milestones

- Provides coordination and implementation of projects to assure compliance with International Council for Harmonization (ICH) /Good Clinical Practice (GCP), Good Epidemiologic Guidelines (GEP) and Good Pharmaco-epidemiology Guidelines (GPP) and applicable regulatory requirements, including data protection and project procedure

- Ensure the development of project required deliverables, such as, but not limited to: Feasibility assessments, Regulatory Submissions, Scientific Writing, Gap Analysis, etc.

- Lead team meetings to enable effective information sharing, discussion, and decision making. Prepare and lead Investigator meetings

- Provide oversight to contracted vendors, review contracted specifications, and maintain regular interactions with vendors

- Responsible for implementation and management of Clinical Studies, ensuring that goals of time, budget and quality performance are met, according to all applicable Regulatory Requirement

Perfil ideal

- Bachelor's Degree or above in a health science field, namely pharmacy or biological sciences, experience in pharmaceutical or medical device research, or related health science field

- Proficient in English

- Excellent verbal and written communication skills

- At least 5-7 years of experience in clinical research, and at least 3 years of experience in managing complex regional or global projects Previous

- Experience in Clinical Trials and Real World Evidence, in a pharmaceutical, biotech company or a CRO. Strong experience in the development and implementation of clinical studies

- Motivation and Flexibility, ability to manage assigned responsibilities and capable to work independently and be self-motivated

- Demonstrates effective interpersonal skills of leadership and critical thinking skills and have the ability to effectively manage shifting priorities, be an excellent decision-maker and creative problem-solving

- Ability to acquire strong knowledge and help develop PM processes and SOPs, to foster collaboration and coordination amongst a diverse group (disciplines, individuals, countries/cultures) to achieve desired goals

- Demonstrates knowledge and clear understanding of the drug development process and understand, interpret and explain medical details associated with projects

- Proficient use of computer and Office tools (Excel, PowerPoint, Word) and Endnote, Articulate

- Good interaction with medical/ clinical and research community to help implement the Company`s new research line. Interact with marketing department

Vantagens

Excellent opportunity to join a renowned company in the portuguese market.

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