Clinical Operations Manager Santiago Job Description
Join us in our mission to INVENT the future. Lets be part of our team of dedicated, energetic individuals who are committed to be the most trusted supplier of pharmaceuticals and health products worldwide.
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rig
orous scientific and ethical standards.
Key Responsibilities PERFORMANCE & COMPLIANCE Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with international and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS Responsible for... execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. MANAGEMENT & QUALITY OVERSIGHT Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. COLLABORATION Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable. LOCAL PROCESS OVERSIGHT Oversight and coordination of local processes. Clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
Qualifications Bachelor holder
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
What we look for
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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