I am looking for an experienced Clinical Study Manager who wants to operate at a leading pharmaceutical company
Over de functie
Yacht Life Sciences has a vacancy for a Senior Clinical Study Manager. This concerns a temporary position for 3 to 6 months (extension might be possible). This role can also be performed by a freelancer.
As a Senior Clinical Study Manager (CSM) you will manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Moreover, you will manage and lead cross-functional study teams, including vendors.
The CSM will provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues. You will lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
Further responsibilities are the implementation of appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data. You lead preparation of vendor requirements and project scope and selection of study vendors; you effectively manage interactions with the vendor study team and lead feasibility assessment and selection of countries and sites for study conduct.
As a CSM you oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results. You participate in data reviews and review of statistical analysis plans. Furthermore, you ensure the set-up and implementation of effective investigator and site monitor training. You coordinate operational and therapeutic area training for internal and external study team members.
The CSM participates in process improvement and quality-related initiatives associated with study execution and deliverables. You will participate in establishment of best-in-class processes and standards for study conduct. Finally, as a CSM you will provide oversight and direction to study team members for study deliverables. You may provide direction to CSM's, associate CSM's and Clinical Trial Associates for assigned studies. You are responsible for the preparation and management of budgets, timelines and resources for assigned clinical studies and you will be responsible for study budgets up to $100M.
- 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;
- In-depth knowledge of Urology, Oncology, Nephrology or Pain Management;
- Structured, accurate and pragmatic work approach and attitude;
- Excellent interpersonal, written and verbal communication skills;
- Excellent administrative skills and computer ability;
- Team player and motivation skills;
- Flexible in working hours;
- Willing to work from home;
- Willing to travel up to 25%;
- Excellent communication skills and a good command of English
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 uptodate: boosting your career through personal and scientific growth.
A multinational pharmaceutical company providing innovative medicines in areas of health where there is urgent need for better treatments.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
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.