Ref #: 29205

Employment type: Permanent - Full-Time

Location: UK

Posted: 14-May-2021

Description

Responsibilities include;

- Provides operational expertise to the study team.
- Lead the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
- Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
- Create team culture and promotes team spirit within the GSMs and GSAs assigned to the study team.
- Provide mentoring and guidance to the operations team ensuring effective collaboration and communication with the study team.
- Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process.
- 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.
- Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
- Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
- Interface with third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
- Oversee the clinical trial insurance process; track approvals, revisions and renewals of certificates.
- Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.

Essential;

- University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
- Thorough understanding of drug development process, 3-4 years clinical trial experience
- Experience of working with and delivering through strategic partners and 3rd party vendors
- Excellent knowledge of ICH-GCP principles
- Ability to lead, coordinate and prioritise multiple tasks and deliverables
- Ability to manage change and actively seek and champion more efficient and effective ways of working
- Ability to coach & mentor for more junior colleagues
- Some travel may be required

If you are seeking a true leadership opportunity and the next step in your career, with a competitive salary and benefits package, together with long term development opportunities, please send your CV for review to alison.burton@docsglobal.com as soon as possible