Clinical Trial Support

What we offer

Get the opportunity to be part of the early-stage of oncological clinical trials and be the detailed-oriented eye we need to make sure that everything is running administratively smooth.

Joining our consulting team 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

You will be delivering support to the Early Stage Development Europe Operational team and you will also be providing operational and project support.

The tasks will include, but are not limited to:

• Assemble and track availability of essential documents required for study conduct.
• Update, maintain and monitor Clinical Trial Management System (CTMS) to allow accurate project management and regulatory reporting.
• Updating of clinical and study planning spreadsheets/trackers.
• QC of essential documents, clinical milestones and other study documentation for completeness, consistency and accuracy.
• Follow-up/check return or destruction of study drug.
• Update of clinical and study planning databases.
• Review study budgets/clinical trial agreements for consistency with study protocol (anti-bribery + corruption checks on fact finding, workflows, tracking, renewals).
• Clinical trial payments and payment tracking (financial disclosure, denied parties screening, compliance checks, disclosure agreements, generate and track Trial Master File reconciliation of clinical grants/compliance documents).
• Maintenance of trackers: enter and track payments in the Grants Management System, run reports execute payments in COMET (SAP), purchase orders as needed.

Profile

• Bachelor degree (e.g. medical assistant, or paramedical education) or Master degree in health science.
• 1-2 years of experience in a pharmaceutical environment.
• Advanced computer skills: e.g. professional using of MS Office programs for daily business (Excel).
• Able to build quick basic understanding of SAP COMET, Grants Management System en eTMF (VAULT).
• Advanced communication skills (written and verbal) in local languages and English.
• Understanding and knowledge of study protocols and study working documents, lab manuals, etc.
• Good understanding of the clinical research processes.
• Understanding of the ICH/GCP (international good clinical practice guidelines and harmonization) and local clinical trial regulations.

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.