Contract Clinical Study Management Associate
ProClinical is advertising a vacancy for a Contract Clinical Study Management Associate position with a global biopharmaceutical company. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide. The role will be based in the company's Cambridge office.
The Study Management Associate will be accountable for assisting Associate Directors Study Management and Study Management Leads in fulfilling their accountabilities through coordinating activities that ensure quality, consistency, and integration of study data and clinical trial processes, along with providing administrative support. The exact accountabilities will differ depending on the exact nature of the clinical programme, so a high degree of flexibility is required.
- Contribute to the development of study documents as appropriate as well as any updates/amendments to those documents.
- 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.
- Prepare presentation material for meetings, newsletters and websites.
Skills and Requirements:
- University degree in related discipline, preferably in medical or biological science, or discipline associated with Clinical Research.
- Deep understanding of the drug development process, study management and data management.
- At least 1 year of Early Phase Oncology experience.
- Excellent knowledge of ICH-GCP and basic knowledge of GMP/GDP.
- Experience of working with and delivering through strategic partners and 3rd party vendors.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Matthew Pike at +207 440 0639 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.
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