Clinical Trial Manager Bardi

Clinical Trial Manager
Bardi
Emilia Romagna, Bardi

NMS Group is the largest company in Italy, committed in innovation and research and

development in oncology.

Nerviano Medical Sciences srl, representing the innovative heart of the

group, is looking for a

**CLINICAL TRIAL MANAGER**:

**Main responsibilities**:

The position reports to the Head of Clinical Operations and will be a reference figure in the team consisting of a total of 4 colleagues.

It is a position that functionally coordinates cross-functional teams dedicated to trials.

The purpose of the position is to lead and coordinate the activities necessary for the correct implementation of multi-country clinical trials in the oncology field, early phases, and to guarantee the company continuous availability of up to date and reliable clinical trial data.

- Assess the feasibility of projects from an operational point of view, where applicable.

- Coordinate and lead the Clinical Trial Team (CTT) ensuring the availability of documentation for meetings.

Liaise with e. g.

Clinical Research Associate (CRA), Data Manager, PV Manager, Regulatory Affairs Manager, etc.

for study related activities.

- Participate in the Company cross-functional meetings, interface and supervise with contractors, collaborators and any party involved in assigned CO activities, if applicable.

- Contribute to the selection of investigator/investigational sites according to project requirements.

- Advise on the project-specific budget for investigators/investigational sites and related contractual arrangements.

- Assisting in the preparation of clinical trial (CT) documents for initial submission to regulatory authorities and IEC/IRBs and subsequent maintenance.

- Ensure the preparation and update of study manuals and plans, as appropriate.

- Ensure the preparation, maintenance and archiving of study documentation.

Perform study set-up, review and maintenance into Veeva system (e. g.

account management, periodic review).

- Where appropriate, provide project-specific training or retraining to relevant persons.

- Provide supervision of project related monitoring activities.

- Perform oversight on protocol deviations that occurred during the conduct of the study, contribute to assess their impact and liaise with the function and sites concerned for corrective/preventive actions.

- Contribute to IMP related activities.

- Contribute to the management of drug recalls and other urgent safety measures, as appropriate.

- Scientific degree (Biology, Pharmacy, Chemistry).

- Fluent knowledge of the English language, written and spoken.

- Experience, preferably at least 5 years, gained in Clinical Trial Manager/Clinical Project Manager positions in early clinical development of oncology compounds in pharmaceutical companies or CROs, Biotech, etc.

with responsibility for multi-country trials, preferably in EU and US.

- Excellent organizational, planning and problem-solving skills.

- Good interpersonal skills, habit/aptitude for working in complex and international contexts.

- Team working orientation, engagement and project management skills.

- Ability to act on several fronts at the same time, excellent relationship skills, aptitude for cross

- functional team working.

- Ability to carry out technical-economic feasibility analyses of requests and sense of responsibility.

**Location**:

Nerviano (Milan) and position can be held remotely for 2 day for week.