Rita Videira

Ad interim position (during 13months) replacing a maternity leave.

Main responsibilities:

1. Deliver a clinical performance index ≥100 by anticipating recruitment challenges and opportunities, and act on those, leading the CRA Team (15 people)

2. Ensure the achievement of study objectives in terms of timeliness, recruitment, performance, productivity and quality.

3. Maintain a competent clinical team to fulfill the assigned clinical trials

4. Establish and maintain the professional relationships with internal and external stakeholders

5. Promote WLB (EVOLVE 2023) by mainly adopting new ways of working within the team.

Project management of assigned clinical trials to ensure deliverables and high quality execution of clinical trials in PT, ES and FR.

Main responsibilities:

1. Accurate planning and co-ordination of operational feasibility of trial timelines and oversight of trial preparation to ensure trial team members are aligned and on-track;

2. Development and implementation of country level recruitment and retention plans and implementation of risk mitigation plans;

3. Ensure quality of clinical monitoring and deliverables;

4. Global review CTMS, CRF, drug management, Safety, TMF and/or other dashboards; Review content and quality of site monitoring documentation.

Accountable for study planning, start-up activities and activation deliverables of assigned projects

Main responsibilities:

1. Ownership of country/site budgets.

2. Development of clinical trials agreements and its negotiation with several sites.

3. Submission of clinical trials to Health Authorities/Hospital Board with close contact to ensure timelines are kept.

4. Country Feasibility in Diabetes/Obesity/RareD and NTAs; Participation in the Trial Portfolio Review

To manage clinical trial sites at every stage of the clinical trial process to a high quality in accordance with SOPs and procedures, compliance with the clinical study protocol and local and global regulations and guidelines whilst maintaining the standards of the Novo Nordisk Way.

Monitoring in Spain, Portugal and UK (whenever needed as backup of my colleagues in UK).

CRA trainee responsible for the monitoring tasks mainly in Spain. Coordination of local CRAs in Ireland, Italy and France. Know-how of the regulatory activities in these countries

Scientific research related with a discovery of a possible new target for Parkison's Disease with implementation and development of behaviour studies for animal experimentation.