Excellent opportunity for a clinical trial assistant in the pharmaceutical industry
Over de functie
Yacht Life Sciences has a vacancy for a Clinical Study Associate. This concerns a temporary position for 3 to 6 months (extension might be possible).
This position will assist the Lead Clinical Study Manager and the clinical team in the day to day activities for managing clinical study(ies) conduct to support completion per established project team goals and objectives. The scope of this position is phase I through IV clinical studies including registries and observational studies.
- Assist in the day to day support of study operations including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study.
- Assist in study set-up including but not limited to eCRF design, protol preparation, informed consents, investigator selection, systems (e.g., CTMS, IVR, etc.), study related operational manuals, trainng materials, and various study plans (e.g., visit logs, drug inventory, monitoring plan, etc.).
- Process and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator payments and other study related activities as needed.
- Assist in the management of study completion activities including data review and clinical study report review.
- Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and/ or submission of regulatory documents to the TMF and ongoing document reconciliation.
- Assist in maintaining accurate and up to date study information within CTMS and other relevant tracking systems.
- Effectively communicate with study team members and work closely with Lead Study Manager to address challenges.
- May participate in process improvement and quality-related initiatives associated with study execution and deliverables.
- Bachelor degree
- At least 2 years clinical trial experience in the pharmaceutical industry or at a CRO
- General knowledge of drug development and ICH / GCP
- Fluent in English (oral and written)
- Must have excellent interpersonal, written, verbal, presentation administrative and computer skills
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.