Excellent opportunity for a home-based Clinical Research Manager at a leading biotech company
Over de functie
Yacht Life Sciences has a vacancy for a Non-Core Country Oversight Clinical Research Manager. This is a home-based position.
As a Clinical Research Manager you will:
- Follow-up on start-up activities with CRO Regional Lead. Identify and escalate issues and delays as appropriate.
- Follow-up pro-actively with the Global Trial Leader/Clinial Trial Manager (GTL/CTM) that startup and country commitments are met via action plans
- Support onboarding of new hires and approve access requests for Global Clinial Operation systems
- Contact person for process related questions in the non-core countries
- Follow-up with the CRO Regional Lead(s) that all new staff have access to supporting systems, are trained, and are pro-actively checked as to whether they are up to date for all trials/countries: CTMS, ICD, CTSRS, VTMF
- Challenge review of MVR by Local Trial Manager (LTM) and discuss KQPI metrics with local team
- Schedule regular update meeting with the RSU/LTM to discuss study progress and issue resolution
- Maintain oversight on investigator contracts & amendments, and HCC adherence
- Maintain oversight on 3rd party vendor contracts & amendments, if applicable
- Maintain oversight that feasibilities are done on time and with quality. Provide comments on CFR when CRO submits to GTL/CTM.
- QRM metrics report: Drill down in QRM, when needed to the site level and communicate to CRO staff so that actions can be taken per site + FU
- Collaborate with internal Quality Manager
- Ensure with CRO that all KQPIs are green for the relevant non-core countries
- Provide support during audits and inspections in the non-core countries
- MSc degree with at least 10 years multi-country clinical trial experience or advanced degree (PhD) with at least 7 years clinical study management experience (phases I-IV) within the pharmaceutical industry
- Profound knowledge of ICH-GCP guidelines and regulatory guidelines and directives that apply to clinical studies
- Experience with protocol and clinical drug development processes
- Experience with clinical study design, study planning and management
- Experience with clinical study monitoring
- Great leadership and project management skills
- Structured, accurate and pragmatic work approach and attitude
- Excellent interpersonal, written and verbal communication skills
- Excellent administrative skills and computer ability
- Flexible in working hours
- Willing to work from home
- Excellent communication skills and a good command of English
This is a full-time, home-based role with occasional travelling.
We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
A global biotechnological company that develops, acquires, and commercializes pharmaceutical products and biopharmaceutical therapies.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer +31 0612387998
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.