Clinical Operations Manager Lazio

Clinical Operations Manager
Roma
Lazio, Lazio

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.

In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change.

We bring a human touch to every treatment we pioneer.

Join us and make a difference.

**The Role

We are looking for the **Clinical Operations Manager** who will lead and manage a **Team of Clinical Trial Monitors regionally based in the North of Italy**.

This position will ensure delivery of clinical operations effectiveness in RCO South East Europe and will be based in Milan.

**Key Duties And Responsibilities

- Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Monitors (CTMo) to ensure timely execution consistent with R&D and local research goals and priorities

- Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.

- Anticipates resource needs and provides workload evaluations and task assignments

- Allocates and assign study resources in alignment with R&D and local research goals and priorities.

- Supervises clinical trial execution at country level including supervising study metrics and team performance

- May propose and/or validate country study targets

- May support Health Authority inspection and pre-inspection activities

- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

- Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available

- Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met

- Together with the RCO management tracks and manages performance metrics for Clinical Operations staff

- Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit

- Point of Contact for FSP staff within the country/cluster

- Managing the hiring, performance management and succession planning of staff

- Performing general and human resource administrative functions

- Participation in performance calibration and talent review meetings

- Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)

- When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager

- Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed

**Qualifications, Knowledge and Skills Required

- ** Bachelors or Master degree required.

Field of study within life sciences or equivalent**:

- ** Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs**:

- Significant experience in the planning, conduct and management of clinical programs (Phase I-IV)

- Demonstrated ability to drive project related activities

- Previous supervisory and/or leadership experience (i. e.

participation in task force, initiative or cross functional team)

- Previous resource allocation experience preferred

- Experience mentoring and providing feedback to others

- In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs

- In depth knowledge and understanding of clinical research processes, regulations and methodology

- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management

- Demonstrated organizational and planning skills and independent decision-making ability

- Strong organization and time management skills and ability to effectively manage multiple competing priorities

- Outstanding interpersonal, oral and written communication skills to influence, inform or guide others

- Advanced proficiency in English and in Italian

- L'appartenenza alle categorie protette, lg.

68/99 costituirà titolo preferenziale. _

**What's important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

**Passion**_: Our dedication to learning and excellence helps us to deliver exceptional results.

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**Innovation**: _We pursue disruptive and bold solutions for patients.

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**Urgency**: _We move together with speed and quality because patients are waiting. _

**Accountability**: _We