Contract Senior CTA - REMOTE

Proclinical are recruiting a Contract Senior CTA for a cutting-edge pharmaceutical organisation. This role is on a contract basis and has the opportunity to work remotely in the United Kingdom.

The Senior Clinical Trials Assistant will support the Study Team Leader (Manager/Associate Director/Director Clinical Operations) in the efficient and effective leadership for all stages of the trial execution.

Responsibilities:

• Act as secretary to the Study Team, (producing agendas, minutes and action tracking and management) and provide support to the Study Team Leader
• Provide project administrative support to assigned clinical trials, working pro-actively and in liaison with the Study Team Leader
• Create, update, track, and maintain project-specific management files, tools, and systems to support Sponsor oversight, in liaison with the Study Team Leader
• Support document management to ensure project and study files are maintained, and always inspection ready
• Support drafting, quality control (QC) and publishing of study documents including informed consent documents, draft source documents, patient instruction guides and case report forms, working closely with internal stakeholders and external partners
• Coordinate internal and external review and approval of trial documentation such as, manuals, contract agreements, oversight plans, operational plans, risk management plans, communication plans, clinical study activity plans etc.
• Support development and review of trial guides and tools for Investigator sites and trial team
• Support communication with CROs, Investigator sites, and clinical sub/project teams as appropriate
• Support development of trial communications such as newsletters and presentations
• Support and manage CRO activities through review and maintenance of regular KPIs/dashboards/reports, meeting minutes and tracking of actions, with escalation to the Study Team Leader
• Co-ordinate meetings with clients, investigators and internal team, including scheduling, sending invitations, coordinating agenda, materials and presentations and taking accurate and complete minutes
• Track study progress such as regulatory and ethics submissions, follow-up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools, when not outsourced to CRO(s)
• Act as a contact for CRO, Study team and study sites
• Support budget management for the trial; purchase order requests, financial reporting requests, invoice tracking and financial reconciliations against finance tools
• Create, update and maintain clinical department management tools and systems, as required
• Assist with the management and tracking of study non-clinical supplies to CRO/sites and organise shipments, where required
• Assist with the management and tracking of study clinical supplies to sites, in liaison with study vendors and in-house staff, where required
• Assist the Study Team Leader and Clinical Operations team in any another activity, as appropriate

Key Skills and Requirements:

• Degree in life sciences or equivalent subject preferred
• Demonstrable prior experience of providing administrative support in a clinical or laboratory environment
• Previous experience acting as secretary to study teams executing clinical trials
• Computer literacy (including relevant software, such as Excel, Word, PowerPoint, Adobe plus specific regulatory packages)
• Familiarity with clinical study documents
• Basic knowledge of ICH-GCP, EU Directive and relevant regulations an advantage
• Previous experience working in a small organisation (small biotech will be beneficial) and/or managing vendors/CROs
• Excellent English oral and written communication skills
• Highly methodical and organized, including time-management skills and attention to detail.
• Enjoys working in a regulated environment and willing to comply with Standard Operating Procedures and Policies
• Clear affiliation with our vision and values, and a true ambassador of our organisation
• Proven ability to effectively prioritise workload and strong organisational skills
• Strong attention to detail and pride in the quality of their work
• Excellent written and verbal communication skills
• Holds a passion for collaborative working, building relationships and excellent stakeholder management experience

If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 4400 639 or m.pike@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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