- Company Name
- Keyrus Life Science
- Job Title
- Clinical Research Development Lead
- Job Description
-
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 Junior Clinical Research & Development Lead to join our consulting team for a client project based in Walloon Brabant (Belgium).
The goal of the Clinical Research & Development Lead (CRDL) it to participate to Phase I-IV Clinical Development Activities within a program or group of related programs in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and standard operating procedures (SOP).
Your Challenges Will Be To
Contribute to activities or components of a Clinical and Epidemiology Plan (CEP) as appropriate.
Define the outline and content of the protocol.
Analyse and interpret the results as a subject matter expert.
Supervise the study conduct, and serve as the accountable for the overall delivery of the clinical trial.
Assure that results meet the highest standards of quality and ethical conduct.
Support to Independent Data Monitoring Committee (IDMC).
Complete tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
Support the regional clinical strategy for a project through Clinical development, in partnership with relevant matrix team members.
Serve as a scientific and management representative for the project:
Assume accountability for the medical/legal and human safety aspects of the clinical study.
Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program.
Address scientific and medical issues related to one or more clinical studies. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
Liaise with PV to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), as applicable. In clinical studies, together with PV analyse safety and potential signals and escalate accordingly.
Publish clinical data in peer review journals and presents in external scientific meetings / congresses.
Maintain and expand knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology.
Support internal process improvement activities and initiatives.
Liaise with the Regional Evidence Generation team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subjects safety).
As a member of the Clinical Project Team, always actively participate and engage within the project matrix:
Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
Actively participate in preparing the clinical portion of the regulatory files and the registration process.
Contribute to development of clinical section of regulatory files, including labelling.
Profile
Experience: 2 years experience in clinical research or safety in a CRO, hospital or pharmaceutical environment (vaccinology is an asset).
Education, Methodology & Certification Requirements
MD or PhD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharma-co-epidemiology
Language Proficiency: excellent spoken and written English.
Knowledge/skills
Basic knowledge and understanding of vaccines, clinical research, and biomedical research regulation, including ICH and GCP.
Possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences.
Working knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape.
Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum.
Strategic thinking skills and achievement oriented.
Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks.
License to practice medicine and board and/ or professional certification is an asset.
Experience
Previous experience in clinical vaccinology is an asset.
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 skilfully, 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.
#clinicalresearch #clinicaltrials #vaccines
