Senior Clinical Research Manager
(m/f)
Referencia: JN -032025-6691235
Adicionado em 12.03.2025
Sobre os nossos clientes
Our client is a pharmaceutical company with experience in various therapeutic areas.
Descriçăo da oferta
The Senior Manager will manage all operational phases from planning to completion in a completely autonomous manner and operates with very limited supervision. Will also be responsible for building an in-house clinical trials/ studies team of the new Unit the Company is creating, and coordinating subcontractors, with senior management support. Reports to Senior R&D Director.
Principais responsabilidades
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…;
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.
Perfil desejado
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;
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;
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;
Proficient in English;
Excellent verbal and written communication skills;
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.
Benefícios adicionais
Excellent opportunity to join a renowned company in the portuguese market.
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