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, 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 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
• 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

Benefícios adicionais

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