Clinical Operations Lead

Purpose

Accountable for all operational aspects in the set-up and management of clinical trials (pre-and post-market). To lead the proactive management of site performance (recruitment and retention, data collection, document collection, TMF review etc), including vendor oversight as needed, and to inform the Global Clinical Team of progress.

Key Responsibilities

• Responsible for planning, conducting, and reporting on all assigned clinical trials.
• Contribute medical/scientific/feasibility input for the development of study documents, including the Clinical Investigational Plan. Collaborate with Medical Advisors to ensure expert feedback is adequately integrated into the protocol.
• Ensure protocol and all auxiliary documents, including manual of procedures, informed consent template, investigator brochure, statistical analysis plan, data validation plan, etc. are written in high quality.
• Managing development and implementation of patient recruitment and patient retention strategies.
• Liase with external vendors on clinical trial status, timelines, budget and execution.
• Ensure trials are carried out according to the protocol, SOPs, and ISO/GCP regulations, and documents are inspection ready.
• Manage logistics related to clinical studies with ordering, sending and tracking of study materials.
• Forecast trial resource needs. Accountable for the development, management and tracking of trial budget.
• Manage study feasibility assessment to select relevant regions and countries.
• Identify, select, and monitor performance of investigational sites for clinical trials.
• Interface with different departments to ensure that clinical activities are in line with overall strategic goals including: Quality, R&D, Marketing and Sales.
• Oversee and provide input to clinical supplies forecasting, device accountability and device reconciliation.
• Other duties as required
  
  

Qualification

• Bachelors’ degree in Medical Science, Nursing or equivalent education required.
• 2+ years in clinical research or clinical operations or relevant scientific, industry, therapeutic or geographic experience and experience with managing external vendors.
• Solid understanding of the Operational process of performing clinical studies of medical devices and/or pharmaceuticals
• Solid understanding of the clinical trial regulations and guidelines (GCP, FDA, ICH, ISO, ANSI, etc.)
• Strong background in ophthalmology (preferred but not limiting)
• Fluent in English
  
  

Company

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com