Clinical Trial Assistant Milano

Clinical Trial Assistant
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.

**Clinical Trial Assistant, Country Operations Management

**Location - Field-based Italy

**This is what you will do**:

The Clinical Trial Assistant (CTA) assists in the coordination of study activities from the start up to execution and close out within Country Operations Management (COM) to ensure quality and consistency of trial deliverables to time, cost and quality objectives according to Good Clinical Practices (GCP), Alexion Standard Operating Procedures (SOPs) and evolving regulatory requirements.

The CTA collaborates closely with the Project Manager Country Operations (PMCO) and other COM functions such as Study Start Up (SSU), Clinical Research Associates (CRA), Site Management Leads (SML) and Head of Country Operations (HCO) in delivering support in the conduct of clinical trials in region or country.

**You will be responsible for**:

- Providing support to the COM team in achieving quality and timeliness of study deliverables across the lifecycle of assigned trials (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation)

- End to end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone management in the Clinical Trial Management System (CTMS) and other general trial support in the country or region as delegated or per assigned trials.

- Providing support to the COM team and/or SSU team during start-up phase: CDA delivery and negotiation, distribution and collection of documents, communication with sites during contract negotiation phase, Site File preparation and preparation and approval of sites for activation, etc

- Collaborating with COM, CRAs and study vendors on the preparation, supports the handling and distribution of clinical trial supplies and maintenance of tracking information

- Act as a central point of contact for the COM team for designated project communications, correspondence, and associated documentation.

- Input on the development and maintenance of project management and other global tracking tools (e. g.

: CTMS, smartsheets, etc.

).

- Collaborating in global initiatives to standardize processes within and across countries (collaboration with other local and global CTAs)

- Assist with local language translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions, as required within the country/region.

- Providing support to local COM team with local F2F study and team meetings (venue, cost, agenda, etc.

), support team teleconferences, assist with staff onboarding as required by country/region

- Depending on the country/region, the CTA may provide varying levels of COM support to the department rather than to assigned studies as needed.

**You will need to have**:

- Bachelor's Degree in a related discipline, preferably life science.

- Proficiency with MS Office Suite (excel, word, PowerPoint)

- Understanding of the drug development process either via education or experience in the life sciences field.

- Excellent collaboration and interpersonal skills, unafraid to ask questions.

- Strong organizational skills and ability to manage competing priorities.

- Strong attention to detail

- Effective written and verbal communication skills

- The duties of this role are generally conducted in a field environment.

As is typical of a field-based role, employees must be able, with or without an accommodation to: travel by public transportation, automobile, train, or plane; work comfortably in a clinical setting; use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

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

- Prior experience working in clinical research

- Medical knowledge and ability to learn relevant Alexion rare disease areas.

- Ability to work in an environment of remote collaboratorsand in amatrix reporting structure

- Manages change with a positive approach for self, team and the business.

Sees change as an opportunity to improve performance and add value to the business.

- Ability to look for and champion more efficient and effective methods/ processes of delivering quality clinical trials with reduced budget and in less time.

- Team oriented and flexible; ability to respond quicky to shifting d