Clinical Site Manager

Buscojobs; Umbria; Ibrido; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading company in healthcare is seeking a Clinical Site Manager to act as the primary contact between sponsor and trial sites. The role involves ensuring compliance with clinical trial protocols while managing site relationships effectively. The successful candidate will work in a hybrid model with flexibility and will require a mix of strong clinical oversight and excellent communication skills.

Servizi

Opportunity for continuous development

Flexible working conditions

Challenging and diversified job in an international setting

Competenze

• Solid experience in site monitoring and management.
• Strong working knowledge of GCP, local laws, and regulations.
• Proficient in English and the primary language of the country.

Mansioni

• Act as primary local company contact for assigned sites.
• Work with site to ensure compliance with SOPs and regulations.
• Manage up to 10 sites across 2-4 clinical trial protocols.

Conoscenze

GCP

Oncology

Ophthalmology

Gene Therapy

IT skills

Formazione

BA / BS degree in life science or equivalent

Descrizione del lavoro

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity :

As a Clinical Site Manager (CSM), you will serve as the primary contact point between the Sponsor and the Investigational Site. You will be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up to site closure. You will manage the site / sponsor relationship as it relates to clinical trial delivery through consistent communication and support.

You will partner with the Clinical Trial Lead (CTL), Clinical Trial Manager (CTM), Clinical Trial Specialist (CTS), and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial-related activities for assigned protocols.

Hybrid Working :

At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Responsibilities :

• Acting as a primary local company contact for assigned sites for specific trials. Trials may include both early and late-phase clinical trials.
• Driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study-specific systems and other reports / dashboards), and site / study close-out according to SOPs, Work Instructions (WIs) and policies.
• Being responsible for implementing risk-based monitoring approaches at the site level and working with the site to ensure timely resolution of issues found during monitoring visits.
• Ensuring source and other site documentation is adequate and in compliance with ALCOA-CCEA. Ensuring site compliance with the study protocol, ICH-GCP, and local / country regulations.
• Taking accountability for up to 10 sites across 2-4 protocols, dependent on the complexity of protocols and site activity. Being responsible for managing own travel budget within Astellas T & E guidelines.
• Strong working knowledge of GCP, local laws and regulations, assigned protocols, and associated protocol-specific procedures including monitoring guidelines.
• Solid experience in Oncology, Ophthalmology, and / or Gene Therapy.
• Strong IT skills in appropriate software and company systems.
• Extensive site monitoring and / or site management experience.
• Proficient in English and the primary language of the country of employment.

Preferred Experience :

• Worked cross-functionally and within matrix teams.
• Mentored junior site monitors and site managers.
• Involved in early development studies.

Education / Qualifications :

• BA / BS degree in life science or equivalent.

Additional Information :

• This is a permanent, full-time position.
• This position can be based in the UK, Poland, Italy, Germany, and Australia.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Milano office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

What We Offer :

• A challenging and diversified job in an international setting.
• Opportunity and support for continuous development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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