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Country Trial Manager, Belgium - L

Employer
ClinChoice
Location
Belgium
Salary
Competitive
Start date
14 Oct 2021
Closing date
28 Oct 2021

Job Details

Description:
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


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

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 careers@cromsource.com for more information.

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 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
Skills: Country Manager, Clinical, Clinical Research Organisation, CRO, GCP, Pharma, Pharmaceutical, Start-up activities Location: Belgium Share:

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Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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