Associate Director, Study Lead Country Operations Milano

Associate Director, Study Lead Country Operations
Milano
Lombardia, Milano

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives.

At Alexion, people living with rare and devastating diseases are our Guiding Star.

We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.

We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

**Associate Director, Study Lead Country Operations

**Location**:

Field-based Italy

**Reports To**:

Head of Study Leads, Country Operations or Director Study Leads Country Operations

**This is what you will do**:

The Study Lead Country Operations (SLCO) is the primary point of contact for the Country Operations (CO) team at the global study level and will act as a core study team member.

The SLCO will be accountable for coordinating and driving activities performed by country operations including start up, monitoring, site oversight, quality, and specific study deliverables.

The SLCO will, therefore, be involved in study documentation review, coordinating CO activities globally, and will act as a liaison for other key stakeholders for relevant site and monitoring issues at country level.

The SLCO be responsible for liaising with Country Operations personnel to conduct the feasibility process, providing feedback to the study team regarding potential site and patient numbers.

The SLCO is responsible for utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.

**You will be responsible for**:

**Accountable For**:

- Monitoring and site oversight globally assigned study(ies), representing the monitoring function on the Global Study Team

- Aggregating and communicating deliverables for assigned study(ies), globally, to the Clinical Program Lead (CPL)

- Resourcing and training of Functional Service Provider (FSP) CRAs for assigned study(ies) Validating local CRO resources, as necessary, to support execution of the study(ies)

- Developing and/or reviewing applicable study documents including training materials and reports

- Delivering of appropriate protocol and indication training to Country Operations teams

- Coordinating of startup and recruitment activities at the study level, across all countries

- Ensuring deployment of inspection readiness measures: including preparation of tools and required documentation

**Responsible For**:

- Liaising between Country Operations (CO) teams and the Global Study Team: act as the central point of contact for the CO team for assigned studies

- Standardizing study conduct and clinical monitoring processes across study(ies)

- Collecting site nominations and communications thereof to the CPL

- Tracking trends occurring within the study that may impact other studies and communicate to the SLCO team and other key stakeholders

- Together with the SLCO team, standardizing processes across the studies to improve efficiencies in CO activities

- Defining monitoring requirements including components of Risk Based Monitoring (RBM)

- Supporting risk management and signal detection at a study level

- Acting as a Subject Matter Expert for Sponsor Inspections by Regulatory Agencies or during audits

- Reviewing quality metrics and provide solutions for continuous improvement

- Maintaining a thorough knowledge of disease area and protocols

**You will need to have**:

- Bachelor's level degree required.

Extensive clinical trial experience across a range of highly complex disease areas

- Demonstrated capability of effective CRA and site oversight

- Solid knowledge of clinical development processes with strong emphasis on monitoring

- Track record of establishing effective relationships with investigator sites

- Ability to lead, troubleshoot and influence for quality and delivery

- A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected

- Ability to travel as required internationally and domestically.

Demonstrates flexibility in schedule and willingness to travel up to 25%.

- The duties of this role are generally conducted in an office environment.

As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

**We would prefer for you to have**:

- Masters or Doctoral degree or equivalent in a scientific or business discipline preferred.

- 5+ years of clinical research experience in biopharma or CRO

- Demonstrated project management skills across multiple highly co