A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Contract Clinical Study Management Associate. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK. The Clinical Study Management role is a 6-month contract role with the possibility to extend.
The Study Management Associate is accountable for assisting Associate Directors Study Management and Study Management Leads fulfil their accountabilities through coordinating activities that ensure quality, consistency, and integration of study data and clinical trial processes and providing administrative support.
- Lead the preparation of country specific agreements (SMA), confidentiality agreements, clinical trial applications and other applicable country documents.
- Contribute to review of new/amended/unique SOPs and guidance documents
- Ensure the supply of study materials and Investigational product by liaising with Investigational Product Supply or external service providers as appropriate.
- Support the study delivery team in the implementation of audits and regulatory inspections
- Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the Associate Director Study Management.
- Interface with Investigators, third party vendors, Marketing Companies and internal staff to support effective delivery of a study and its regulatory documents through finalization of the protocol through to the Clinical Study Report (CSR) and administrative appendices
- Maintain and close the TMF, ensuring continual inspection readiness
- Initiate and maintain production of study documents, ensuring template and version compliance
- Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and interface with data management representatives and sites to facilitate the delivery of study data
Skills and Requirements:
- Excellent verbal and communication skills.
- Degree in Scientific field or similar area.
- Previous clinical research experience preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.