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Study Management Associate

Study Management Associate sought for a 12 month contract in Cambridge

Study Management Associate
Location: Cambridge
Contract Duration: 12 months
Remuneration: Competitive


Study Management Associate, Early Clinical Development
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. The exact accountabilities will differ depending on the exact nature of the clinical programme so a high degree of flexibility is required.
Accountabilities:
• 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 web-sites


Education, Qualifications, Skills and Experience
• 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
• A clear demonstration of behaviours of:
1. Ability to prioritise
2. Flexibility
3. Ability to manage multiple deliverables
4. Team oriented
5. Ability to manage change and actively seek and champion more efficient and effective methods / processes
• Good communication, negotiation, collaboration and interpersonal skills



Summary

Job Type:
Contract
Industry
Pharmaceuticals
Location
Cambridge
Specialism
Life Sciences
Pay
Competitive
Ref:
3163170
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Talk to a Consultant

Talk to Sara Havers, the specialist consultant managing this position, located in Cambridge

Terrington House, 13 - 15 Hills Road, Cambridge, CB2 1NL

Telephone: 01625519700

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