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.
CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
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
- Quality submissions of justifications for claims and files relating to registration applications, in a timely manner
- 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
- 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
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @
https://www.talentsourcelifesciences.com/jobs please contact firstname.lastname@example.org for more information.
Who will you be working for?
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 around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Country Trial Manager, CTM, start-up activities, Clinical Research, Pharma, Pharmaceutical, GCP, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated
Country Manager, Clinical, Clinical Research Organisation, CRO, GCP, Pharma, Pharmaceutical, Start-up activities