Medical Director
OPIS **is the number one Italian CRO.
It was founded in 1998 and it is now present throughout Europe.
**Posizione:**:In your role as a** Medical Director** you will be responsible for managing, leading and overseeing all the activities of the Medical Department, ensuring client projects are delivered on time and with high-quality thus guaranteeing client's satisfaction.
**Some of what you will do**:
- Assume overall responsibility for ensuring the quality and timeliness of Medical Department deliverables to sponsors
- Provide the staff with daily guidance, leadership and overall support on issues relating to projects, communication, procedures and executing process to meet customer needs
- Ensure continuous availability to respond to urgent protocol-related issues at the investigative sites, as needed
- Ensure all pharmacovigilance requirements are met
- Define KPI/KQI to guarantee excellent performance, high quality and timely deliverables and maintaining strong relationships with the key stakeholders and partners
- Oversee the activities of the consultants/third party vendors of the Medical Department and approve the related invoices
- Anticipate areas of risk, and plan and implement solutions to mitigate these risks
- Participate in discussions with Regulatory Authorities as appropriate
- Attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
- Define the timeframes and costs of each project and collaborate with the Business Development and the Finance in preparing the biddings and invoices for the sponsor
- Ensure the management of appropriate billable and non-billable time for his/her team and ensure that the activities are entered in the TRACK system, billed and invoiced on time
- Lead Medical Department personnel through inspection/audit situations, including closing out inspection/audit findings and corrective action plans
- Keep Senior Management informed on project progresses and potential issues and ensure alignment with Senior Management on any adjustment
- Conduct annual performance review for his/her staff and provides career development opportunities
- Ensure compliance with SOPs, quality standard, ICH-GxP, and other national and international regulatory requirement
- Utilizes communication skills to reinforce Corporate culture, motivate staff and develop effective working relationships
**Requisiti:**:**Minimum Requirements
- Degree in Medicine
- At least 10 years of experience in clinical research
- Experience in providing medical strategy, direction, development and review for a variety of activities and deliverables
- Strong organization, planning and budget management skills
- Strong analytical skills, attention to detail, and business process orientation
- Strong commitment to quality
- Strategic acumen
- Flexibility and propensity for innovation, process improvement and technology enhancement
- Excellent English language (fluent reading, writing and verbal skills)
- Excellent leadership, presentation, communication and interpersonal skills
- Customer/client orientation, with a strong sense of urgency and results orientation
- Excellent ability to develop important relationships with internal and external key stakeholders
- Excellent ability to motivate and inspire team members
**Altre informazioni:**:We offer a competitive salary with other benefits and opportunity to develop your professional career with a growing company.
We are looking forward to speaking with you!
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