Regional Clinical Trial Manager

6 days ago


Dubai, United Arab Emirates Boehringer Ingelheim Full time

**Regional Clinical Trial Manager**
**-**
**233859**

**REGIONAL CLINICAL TRIAL MANAGER**

**OUR COMPANY**

At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.

Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

**THE POSITION**

The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. CTMs contribute to delivery of BI’s pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites.

The CTM provides leadership and direction to the trial team for their responsible R/OPU and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators. They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g. investigative sites) and trial team members at a regional/local and global level.

The CTM is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the global study team on all study-related issues. As leader of the R/OPU Trial Team, the CTM communicates trial status to stakeholders, escalating issues as appropriate.

**Tasks & responsibilities**

Accountable for the trial activities for responsible R/OPU, including but not limited to:

- Ensure the trial is conducted in compliance with GCP-ICH, local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities.
- Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, and safety reporting.
- Ensures timely cleaning and delivery of clinical trial data.
- Build and maintain engagement with Investigators, other site staff and Patient Organizations (POs), in collaboration with other functions, to ensure trial speed and effective start up, conduct and close out.
- Creates an environment that inspires, motivates, and empowers colleagues and promotes one common CD&O identity, contributing to acceleration of clinical development timelines and value creation for patients
- Fosters a learning culture in CD&O regions by encouraging continuous learning, sharing best practices, and learning from failures.
- Embraces innovative approaches and technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and one common CD&O identity.

**Requirements**:
5 + years of experience of clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams
Experience in Therapeutic Areas relevant in BI pipeline is desirable
Understanding of local/regional major regulations
Familiarity with guidelines and standard of care is desirable
Experienced in working with CROs is desirable
Ability to build and maintain strong relationships of mutual value
Excellent influencing and communication skills

**WHY BOEHRINGER INGELHEIM?**

With us, you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.

**Job**
- Clinical Operations

**Primary Location**
- Africa, Asia, Australasia-AE-Dubai-Dubai

**Organization**
- AE-Boehringer Ingelheim MENA (United Arab Emirates)

**Schedule**
- Full-time



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