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Country Trial Manager

il y a 2 semaines


Brussels, Belgique CROMSOURCE Temps plein

**Location**: Belgium - office based
**Schedule**: Full Time, Permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds.

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a **Country Trial Manager** **(CTM)** to join one of our partner companies. Our client is a global biopharmaceutical company which brings therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products.

**Scope of the role**:
The Country Trial Manager (CTM) is responsible for carrying out moderate to high complexity trial start-up activities for studies assigned at country level. For studies where more than one Country Trial Manager is assigned, he or she can act as the lead (CTM) for the country or group of countries and coordinate all activities at the country or country level. The Country Trial Manager collaborates with the Study Start Up Project Manager, the Study Manager, the Site Intelligence Lead, the Site Relationship Partner, the Site Activation Partner, the Contracts Lead, Regulatory Affairs, representatives of CROs or other internal stakeholders or external if necessary. The Country Trial Manager demonstrates leadership, organizational and planning skills across the country to ensure successful completion of trial initiation activities in accordance with appropriate quality standards including Good Clinical Practice (GCP) of the International Conference on Harmonization (ICH), standard operating procedures (SOP), local operating guidelines and local regulatory requirements, where applicable.

**Main Job Tasks and Responsibilities**:

- Assumes responsibility for the execution of: _
- The implementation of plans for the start-up and activation of centers nationwide
- The countrywide recruitment strategy
- Communication with the internal stakeholders listed above to ensure the efficient and timely completion of the countrywide study start-up
**Education and Experience**:

- A scientific or technical degree, preferably combined with a broad knowledge of clinical trial methods. In general, applicants for this position should have the following levels of education / experience: B. Sc./M. Sc.; a nursing degree or a nursing diploma may also be considered, if accompanied by extensive experience in clinical trials
- Extensive operational experience in clinical trials
- Functional knowledge of Good clinical practices, clinical and regulatory operations and the environment of the countries under his responsibility
- More than 7 years of clinical research experience or experience as a project manager for the start-up and management of studies
- Established knowledge of the interdependencies between the choice of centers, the activation of centers and the preparation of centers
- Established knowledge of clinical trial methods and drug development
- Demonstrated experience leading cross-functional teams
- Demonstrated experience in project management and quality management
- Demonstrated experience in a matrix management environment
- Expertise in the use of center activation tools
**Skills**:

- Proficiency in English and the local language of the region or country is compulsory
- Attention to detail and technical expertise
- Ability to manage complex processes
- Ability to manage a matrix team
- Identification and mitigation of risks
- Skills for strategic planning, analysis and problem solving
- Critical path analysis
- Excellent oral and written communication skills
- Ability to adapt to new technologies and new processes
**Our benefits when working in Belgium**:

- Competitive Salary
- Group and hospitalisation insurance
- Electronic meal vouchers
- Internet reimbursement
- Company Car with fuel card depending on the function
- Dedicated Line Manager
- Regular face-to-face or phone meetings with line manager
- Full annual performance review process
- Ad-hoc team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
**The Application Process**

**Who will you be working for?**

**_About CROMSOURCE _**
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

**_Our Company Ethos _**
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum aroun