Ph3Overview /h3pThese roles are accountable for performance and compliance for assigned protocols in a country in compliance with ICH / GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for diverse aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. /ph3Responsibilities /h3ulliTracking (e.g. essential documents) and reporting (e.g. Safety Reports) /liliEnsure collation and distribution of study tools and documents /liliUpdate clinical trial databases (CTMS) and trackers /liliClinical supply non-clinical supply management, in collaboration with other country roles /liliManage Labeling requirements and coordinate / sign translation change request /liliSupport to CRA for start up activities and site management as required /liliContribute to Execution and oversight of clinical trial country submissions and approvals for assigned protocols /liliDevelops working knowledge of local language materials including local language Informed Consents and translations. May interact with IRB / IEC and Regulatory Authority for assigned protocols /liliSupports country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country /liliProvide support to local vendors as applicable /liliSupport of local regulatory and financial compliance /li /ulh3Qualifications and Experience /h3ulliRequired: Associate Degree or equivalent Health Care related experience /liliPreferred: Bachelor’s degree (or higher) /lili1-2 years of experience in Clinical Research or experience in Finance / Business /li /ulh3Skills and Attributes /h3ulliExcellent verbal and written skills, in local language and English /liliStrong coordination and organizational skills /liliBasic knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up /liliAbility to propose solutions to local study teams /liliICH / GCP knowledge appropriate to role. Hands on knowledge of Good Documentation Practices /liliAble to work with other experienced clinical research professionals to learn and develop skills to manage protocols independently. Works with high quality and compliance mindset /liliEffective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills /liliHigh sense of accountability and urgency in order to properly prioritize deliverables /liliStrong communication and negotiation skills in local language and English /liliAbility to focus on multiple deliverables and protocols simultaneously; capable of working effectively in a remote virtual environment with a wide range of people /liliPositive and growth mindset, capable of working independently and being self-driven /li /ulh3About Us /h3pWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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. /ppIn 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. /ppWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. /ph3Benefits and Logistics /h3ulliRelocation /liliVISA Sponsorship /liliTravel Requirements /liliFlexible Work Arrangements /liliShift /liliValid Driving License /liliHazardous Material(s) /li /ulpemNote: Requisition ID has been removed for clarity. This description focuses on responsibilities, qualifications, and company information. /em /p /p #J-18808-Ljbffr