Surgical Manager

Company Description
Antev is part of NASDAQ listed Medicus, pursuing global clinical trials in Urology and Uro-Oncology.

Role Description
This is a full-time remote role for a Clinical Study Manager. Working closely with the Head of Clinical Operations, the Clinical Study Manager (CSM) will oversee end-to-end clinical trial management and ensure that studies are conducted in compliance with applicable protocols, regulations, and company procedures. Responsibilities include:

• Creating trial protocols
• Managing clinical operations activities
• Monitoring trial progress
• Coordinating with cross-functional teams to achieve study goals
  The role also requires maintaining accurate documentation, ensuring quality control, and providing leadership to project teams of one or more clinical trials or programs, ensuring delivery of associated activities to time, cost, and quality.

Summary

• Work with internal and external teams and providers to ensure clinical trials and development plans are delivered in line with Antev Ltd/Medicus Pharma company strategy
• Develop and maintain clinical study documentation
• Contribute to and oversee filings of regulatory and ethics packages
• Support vendor selection and qualification (CRO/Lab/DM/PV/Packaging, etc.)
• Identify and communicate study issues that will impact budget, resources, and timelines
• Review and negotiate clinical work orders and change orders
• Manage/oversee third-party vendors including Clinical CROs, laboratory vendors, imaging IRT, etc.
• Work with the Head of Clinical Operations to set and maintain study budgets, manage budgetary changes, and review and approve invoices
• Create and maintain positive and effective relationships with international (US & EU) study sites and Principal Investigators
• Work with external providers to ensure drug supply for clinical activities
• Review and approve relevant study plans and specifications including but not limited to CRFs, IRTs, laboratory manuals, pharmacy manuals, risk plans, vendor oversight plans, etc. from an operational perspective
• Manage and oversee TMF and study filing related activities, particularly Sponsor Oversight sections
• Review study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies
• Ensure adherence to GCP, SOPs, regulatory requirements and to departmental policies, practices, and procedures
• Ensure clinical trials/program meets all GCP/ICH Guidelines and are inspection ready

Key Deliverables

• Successful setup of appropriate vendors to support clinical program delivery within the agreed business timelines
• Achieve global and local patient milestones including but not limited to FPI, LPI, LPO, and DBL within agreed business timelines
• Closely oversee global study conduct to ensure site and vendor compliance with regulatory, protocol, and contractual requirements
• Manage study and program budgets to ensure spend is within agreed costs

Qualifications

• Minimum 7 years experience in Trial Management and Clinical Operations
• In-depth knowledge of Clinical Trials, Research methodologies, and regulations (FDA, EMA, and MHRA)
• Ability to develop and execute Protocols and ensure regulatory compliance
• International (US & EU) Site Management experience
• Phase I and II trial experience
• Vendor selection and management experience
• Experience of data management aspect of clinical trial management together with strong data analytical skills

Personal Attributes

• Highly driven & motivated self-starter with the ability to work independently as well as part of the ClinOps team
• Pragmatic, solution-focused, and willing/able to roll up sleeves in a fast-moving, small company environment
• Attention to detail
• Strong organizational, leadership, project management, and problem-solving skills
• Strategic in focus with an appetite for regular audit of practices to generate positive feedback for a continuous improvement approach to trial design and management
• Excellent communication and collaboration abilities
• Familiarity with GCP (Good Clinical Practice) guidelines
• Proven experience in the pharmaceutical or biotech industry
• Willing to travel internationally and nationally (London) as required (at least monthly)
• Bachelor's degree in Life Sciences, Nursing, or a related field (Master’s degree is a plus)