Country Trial Manager

You are an experienced Clinical Trial professional with a interest in a more global role? Then jump right in!
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What we offer

Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

 

Job Description

Keyrus Life Science is looking for a Country Trial Manager to join our consulting team for a cient project based in Anderlecht, Belgium.

The Country Trial Manager (CTM) is responsible for conducting trial initiation activities of moderate to high complexity for studies assigned at the country level. For studies where more than one Country Trial Manager is assigned, he/she may act as the lead (CTM) for the country or group of countries and coordinate all activities at the country or countries level. The CTM collaborates with the Study Start Up Project Manager, Study Manager, Site Intelligence Lead, Site Relationship Partner, Site Activation Partner, Contracts Lead, Regulatory Affairs, CRO representatives or other internal or external stakeholders as needed.

Your will mostly manage the study start-up process and site-activation in assigned countries:

  • Support investigator/country briefing process, center identification, and feasibility by ensuring that countries/centers meet study protocol requirements.
  • Provide in-country input on start-up and recruitment steps to the global research team during planning.
  • Underline risks and deviations of start-up and site-activation plans, and proactively find solutions.
  • Lead the local research team (e.g. in giving advices related to protocol), and make sure that the communication between the local and global team is effective.
  • Make sure that procedures are respected.
  • Provide input on country specific risks in the preparation of the Quality Management Investigation Plan, study monitoring plans; ensure completeness of study master files and monitoring of all relevant compliance activities for assigned studies.
  • Effectively lead recruitment planning at the center to enable implementation of plans at the center and at country level in accordance with the global plan and local goals.
  • Provide input on country-wide per-participant costs, local vendor costs, and other costs if appropriate.
  • Possibly act as a mentor/coach and assist in the onboarding of other clinical trial leaders.
  • Identify and communicate mitigation plans for study start-up that can be effective for multiple countries.


On a more administrative side, your responsibilities will be to:

  • Review reports of center activation visits and Pharmacy technical assistants.
  • Support the implementation of site technology systems expertise (e.g., Shared Investigator Platform [SIP], centralized account management).
  • Gather country-wide documentation (e.g., insurance documents, letter of agreement if required) required for center activation submissions/visits.
  • Support submissions of claims substantiation and records related to regulatory submissions and other relevant submissions (e.g., radiation, biobanking) and responses to missing queries/information for initial and subsequent clinical trial agreement submissions.
  • Support negotiations for clinical trial agreements and budgets and implementation of center payment tools.
  • Set up study master files at the country and center level.
  • Upload country level documents to the Study Master File and Center - Investigator file and ensure completeness of the Study Master Files during study initiation.
  • Create informed consent documents and complete the global review and approval form related to the country, and create informed consent documents and complete the global review and approval form related to the center, if applicable.
  • Manage the procurement of investigational products, equipment and ancillary supplies, including management of import/export licenses.
  • Provide support for the investigator start-up kit process to the operations partner and center activation.
  • Support implementation of new tools and technologies (e.g., electronic consent, Center File - Electronic Investigator, remote source access, remote data source verification/review, iConnect, implementation of decentralized testing options required per protocol).
  • Identify, manage and monitor local vendors/facilities contracted with as per protocol.
  • Support meetings with researchers


Profile

  • Bachelor or Master of Sciences with at least 5 years of experience in an operational role in clinical trials.
  • Experience as a Study Start up Specialist is preferred.
  • Knowledge of Good Clinical Practices (GCP), Clinical and Regulatory Operations.
  • Clinical research experience or experience as a project manager for study start-up and management.
  • Established knowledge of the interdependencies between center selection, center activation and center preparation.
  • Established knowledge of clinical trial methods and drug development.
  • Demonstrated experience leading cross-functional teams.
  • Demonstrated experience in project management and quality management.
  • Proven experience in a matrix management environment.
  • Expertise in the use of center activation tools.
  • Attention to detail and technical expertise.
  • Ability to manage complex processes.
  • Ability to manage a matrix team.
  • Risk identification and mitigation.
  • Strategic planning, analysis and problem solving skills.
  • Critical path analysis.
  • Excellent oral and written communication skills.
  • Ability to adapt to new technologies and processes.
  • Oral and written communication skills with colleagues and other stakeholders inside and outside the company.
  • Trilingual or at least Bilingual (English, French and Dutch).

 

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

 

Or, know someone who would be a perfect fit? Let them know!

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1000 Brussels Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

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