Global Clinical Operations Manager

Descrizione dell'offerta

Johnson & Johnson is an American multinational company founded in 1886, a world leader in the development of products and devices for surgical therapies and pharmaceutical companies, as well as in the marketing of consumer products for personal hygiene, and is organized into three business segments: Pharmaceutical, Medical & Diagnostic, Consumer.

Every day more than 120,000 employees work in 250 companies of the Group, located in 60 countries.

In Italy there are all the three sectors, each of which represents one of the segments mentioned above:

- Janssen SpA (Pharmaceutical Sector):

Marketing Company: Milan

Plant: Borgo San Michele (Latina)

- Johnson & Johnson SpA (Consumer Sector):

Marketing Company and Plant: Santa Palomba (Rome)

- Johnson & Johnson Medical SPA (Medical and Diagnostic Sector):

Marketing Company: Pratica di Mare (Rome).

Janssen-Cilag SpA is looking for a Global Clinical Operations Manager (GCO Manager), to be hired wit a permanent contract in the GCO of Janssen - Cilag.

The GCO Manager position reports is accountable for the successful execution of all phases of clinical trials for an assigned Therapeutic Area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with all GCO SOPs, policies and regulatory requirements. This position is responsible for the direct functional management of Local Trial Managers, Site Managers and other functions, where applicable. Oversees staff development, project assignments, workload distribution, and issue resolution with direct reports in close collaboration with the other Funtional manager and the Country Head.

This position reports to the GCO Country Head and interfaces with the

Regional Therapeutic Area Experts,Quality and Compliance staff and other internal/external business partners as required (i.e., Local Operating Company, Janssen R&D). Alignment of goals with organizational objectives as defined in the GCO local goals objectives.

Responsibilities:

- Evaluates and projects resource needs for assigned portfolio, and manage resource requests as appropriate;

- Interviews, hires, develops and trains staff;

- Is responsible for performance and development in accordance with the Performance Management guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment

- Ensures staff have a clear understanding and knowledge of GCO SOPs, Work Instructions and Company Policies supported by documentation of training compliance

- Ensures adequate, timely, metrics driven and compliant management of clinical studies through all phases of the trial - feasibility through database lock;

- Ensures studies are in a constant state of inspection-readiness. Works with Quality Management (QM) to ensure quality oversight of studies utilizing the available tools;

- Review and approve expenses; assure expenses are in compliance with the company's policies;

- Demonstrate Leadership Behaviors in alignment with Leadership Imperatives;

- Overall accountability for planning, executing and monitoring of clinical trials through all phases of the trial feasibility through database lock, and inspection-readiness for assigned Therapeutic Area or study portfolio in country or for TCSM activities of specific role (s).

- Strong interaction with the R&D/Local Operating Company staff and departments within GCO and outside of GCO, i.e., (Regional Therapeutic Area Experts (RTAE), GCO Medical Affairs regional leadership, Central Trial Coordination (CTC), Integrated Data Services (IDS), Clinical Supplies Unit (CSU), Quality and Compliance (QC) and external vendor groups, Medical Affairs).

- Participates in special initiatives as needed and guides rollout of new processes and procedures

- Collaborates with the RTAE on country capabilities and study placement for assigned Therapeutic Area(s) or study portfolio.

- Accountable for study feasibility in country for assigned Therapeutic area or study portfolio.

- Supports metrics review and necessary follow-up actions

Profilo richiesto

Qualification required:

- Bachelor's degree or equivalent required, preferably in Life Science (e.g Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

- At least 3 years of experience in the same role and as People manager both in Pharmaceutical Industries and in CRO.

- Fluent in English

- Strong financial management skills

- Strong knowledge with MS Office (word, Excel, Access, Outlook, Explorer and PowerPoint)