Gerente Pesquisa Clínica Biopharmaceuticals

Are you ready to lead and inspire Local Study Teams at the country level? As a Local Study Associate Director, you will be at the forefront of delivering clinical studies, ensuring compliance with international guidelines and local regulations. Your leadership will drive the success of our clinical trials, making a significant impact on patient outcomes.

**Accountabilities**:

- Lead Local Study Teams (LSTs) to deliver committed components of clinical studies according to agreed resources, budget, and timelines.
- Perform site monitoring as needed to support the flexible capacity model.
- Ensure sites are identified, qualified, set up, initiated, monitored, closed, and documentation archived.
- Oversee study commitments within the country and ensure timely delivery of high-quality data.
- Lead and optimize the performance of Local Study Teams, ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
- Conduct clinical and operational feasibility assessments of potential studies.
- Coordinate site selection processes and perform Site Quality Risk Assessments.
- Prepare and maintain accurate study budgets and financial agreements.
- Prepare local Master CSA and country-level Master Informed Consent Forms.
- Collect and verify trial essential documents prior to study start.
- Plan and coordinate local drug activities.
- Set up and maintain study information in CTMS and local websites.
- Manage and coordinate monitoring activities from site activation to study closure.
- Review monitoring visit reports and provide guidance to monitors.
- Perform co-monitoring and training visits with study CRAs.
- Identify risks and resolve complex study problems.
- Organize regular Local Study Team meetings.
- Foster good relationships with Local Study Team members, site staff, and global stakeholders.
- Report study progress to the Global Study Associate Director/Global Study Team.
- Contribute to patient recruitment strategies.
- Develop and review risk management plans at the country study level.
- Communicate regularly with National Coordinating Investigator/National Lead Investigator.
- Plan and lead National Investigator meetings.
- Assist in forecasting study timelines, resources, recruitment, budget, study materials, and drug supplies.
- Ensure systems for business-critical activities are set up and maintained.
- Ensure accurate payments related to the study are performed according to local regulations.
- Train and coach new Local Study Team members.
- Ensure completeness of the eTMF and readiness for inspection.
- Plan and lead activities associated with audits and regulatory inspections.
- Provide input to process development and improvement.
- Provide regular updates to Line Managers on study milestones and key issues.
- Ensure compliance with AstraZeneca’s Code of Ethics, company policies, and procedures.

**Essential Skills/Experience**:

- Bachelor's Degree in health area.
- Fluent in English.
- Experience in clinical research management of international clinical trials phase II and III in pharmaceutical industry or CRO.

**Desirable Skills/Experience**:

- Knowledge about Cardio, Kidney or Respiratory studies

At AstraZeneca, we are driven by a passion for science and a commitment to making a difference in patients' lives. Our innovative approach allows us to explore new frontiers in medicine, working on groundbreaking discoveries from early-stage research to late-stage development. Join a team of curious minds who are empowered to ask bold questions, make impactful decisions, and drive change. Here, your work will contribute to transforming the future of medicine.

Ready to make a difference?